Data Analysis Method, Device, Electronic Device and Storage Medium for Pharmaceutical R & D Competition
By constructing a drug R&D competition data analysis method, obtaining and combining drug information tables, and generating date information for the drug R&D milestone stage, the problem of inefficient drug R&D competition data analysis is solved, and real-time monitoring and accurate display of drug R&D progress is achieved.
Patent Information
- Application Number
- CN202111184122.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2021-10-11
- Publication Date
- 2025-07-08
- Estimated Expiration
- 2041-10-11
AI Technical Summary
The statistical analysis methods for the research and development of competitive data of traditional Chinese medicines are time-consuming and labor-intensive, and are prone to missing data, resulting in poor user experience and inefficient replication of drug information in different data sources.
Provide a method for competitive data analysis of drug research and development. By obtaining medical information query requests, a relationship map between target and drug information is constructed, a drug clinical and registration information table is merged, and the start and end date information of the drug research and development milestone stage is generated. The bar graph is used to represent the progress of R&D, and automated data analysis is realized.
It improves the efficiency and accuracy of drug research and development data analysis, and updates the progress of drug research and development in real time. Users can quickly obtain competitive information about innovative drugs and generic drugs, improving the comprehensiveness and visual presentation of data.
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Figure CN113868488B_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the field of computer application technologies, and particularly relates to a method and device for analyzing drug R & D competition data. Additionally, it also relates to an electronic device and a non-transitory computer-readable storage medium. Background Art
[0002] For pharmaceutical companies, the product pipeline is almost the lifeblood of the enterprise. How to initiate research and development and launch suitable drug pipelines in a highly competitive environment is an eternal business focus in the pharmaceutical industry. For the project establishment or strategic development department, the daily routine is to research drug information and make decisions on project establishment or business cooperation based on the research results. Among these information, undoubtedly, the drug R & D competition situation is one of the most critical data. Enterprises especially pay attention to the TOP10 or TOP3 varieties, enterprises or opportunities with advanced R & D progress under the same variety or the same track.
[0003] There are more than tens of thousands of pharmaceutical companies and pharmaceutical R & D enterprises in China, and it is very easy to have homogeneous competition in product R & D. Whether it is generic drug research and development or innovative drug research and development, there is an obvious clustering situation. This clustering also results in a huge amount of information when researching drugs or targets. It is not easy to sort out the progress rankings of each pipeline from a large amount of information, and it takes a lot of time.
[0004] Secondly, the basic information of drugs or targets that enterprises need to research generally includes drug marketing situations, drug registration situations, and drug clinical trial situations. These data are scattered in the domestic and imported drug databases of the National Medical Products Administration (NMPA), the drug registration data of the Center for Drug Evaluation (CDE), and the Chinese Clinical Trial Registry Database of Drugs, which are the three official government data sources. However, the information in these three data sources is in a relationship of mutual intersection, partial overlap, but not completely contained. See Figure 4 。
[0005] When manually sorting out these data, it is necessary to visually distinguish the intersecting information and perform merging and duplicate removal processing to obtain complete, accurate, and non-duplicate basic data.
[0006] Thirdly, due to complex situations such as enterprise name changes, cooperative R & D registrations, transfers of clinical approvals or production approvals, and changes in marketing holders, the enterprise entity or entity name of the same drug will change in different data sources. Manually sorting out this process, clarifying the context of enterprise changes, and finally accurately aggregating the relevant data is a very complex and painful process.
[0007] Finally, the database of government departments is designed for the needs of management processes, not for the needs of industry users. The data obtained by industry users needs to be converted into drug and target data that can be used for research. Taking Chinese marketed drugs as an example, NMPA manages them according to drug approval numbers. The same drug from the same company may have multiple or even dozens of drug approval number information, and the drug approval date, specifications and other information of each information are different. Taking China's drug registration data as an example, CDE manages them according to acceptance numbers. The same drug from the same company may have several or even thousands of acceptance number data. If users want to understand the research and development registration progress, milestone evolution, and milestone dates of the drug, they need to sort out all the relevant acceptance number information to draw basic conclusions, which takes a lot of time and energy and is extremely inefficient.
[0008] In summary, a large number of highly educated personnel in pharmaceutical companies are engaged in the above-mentioned primary research work on drug information every day. Even if they can use some commercial databases to export source data, the sorting process can only be done manually, which is extremely inefficient. Simply researching the basic information of a drug may require reading and sorting thousands of data from multiple data sources. This repetitive sorting work requires a high level of experience and responsibility, but in turn, it seriously lacks growth potential for employees.
[0009] Therefore, the market is in urgent need of more efficient and automated drug R&D competition data sorting methods to liberate the labor of these highly educated personnel and greatly improve their work efficiency. Furthermore, how to express the competitive situation of the R&D of a drug or target in a more intuitive way is also urgently needed by industry users. Summary of the invention
[0010] To this end, embodiments of the present invention provide a drug R&D competition data analysis method, device, electronic device and storage medium to solve the problem that the statistical analysis method in the prior art is time-consuming and labor-intensive, and is prone to data missing, resulting in a poor user experience.
[0011] In a first aspect, an embodiment of the present invention provides a method for analyzing drug R&D competition data, comprising:
[0012] Obtaining a medical information query request, wherein the medical information includes target information and / or drug information;
[0013] Obtain research and development information corresponding to medical information;
[0014] Obtaining the start and end date information of the drug development milestone stage corresponding to the development information;
[0015] Based on the research and development information and the start and end date information of the drug research and development milestone stages, the research and development competition information of the target target and / or target drug is determined.
[0016] Further, according to the above-mentioned method for analyzing pharmaceutical R & D competition data, the R & D information corresponding to pharmaceutical information is obtained, specifically including:
[0017] The R & D information includes at least one of the R & D drug information of innovative drugs corresponding to the target target, the R & D enterprise information of innovative drugs corresponding to the target target, and the R & D enterprise information of generic drugs corresponding to the target drug;
[0018] Among them, the R & D drug information is an information set of innovative drugs corresponding to the target target information obtained according to the target target and a pre-set relationship map between the target and its corresponding drug information;
[0019] The R & D enterprise information is an information set of R & D enterprise information corresponding to innovative drugs under the target target and / or generic drugs under the target drug obtained according to the total drug information table obtained based on the innovative drug information set and / or the target drug;
[0020] Among them, the innovative drugs and the generic drugs are obtained according to the drug property type and the drug registration type;
[0021] Further, according to the above-mentioned method for analyzing pharmaceutical R & D competition data, the total drug information table is obtained through the drug clinical information table and the drug registration and marketing information table;
[0022] Among them, the total drug information table is obtained by merging the drug name information and enterprise information in the drug clinical information table and the drug registration and marketing information table.
[0023] Further, according to the above-mentioned method for analyzing pharmaceutical R & D competition data, the start and end date information of the R & D milestone stage corresponding to the R & D information is obtained, specifically including:
[0024] Based on the drug clinical information table, the start and end date information of the R & D milestone stage in the drug clinical stage is obtained,
[0025] Among them, the R & D milestone stage in the drug clinical stage includes at least one of the following stages: BE test, Phase I clinical trial, Phase I / II clinical trial, Phase II clinical trial, Phase II / III clinical trial, and Phase III clinical trial;
[0026] Based on the drug registration and marketing information table, the start and end date information of the R & D milestone stage in the drug registration and marketing stage is obtained,
[0027] Among them, the R & D milestone stage in the drug registration and marketing stage includes at least one of the following stages: application for clinical trial, approval for clinical trial, application for marketing, approval for marketing, application for consistency evaluation, and approval for consistency evaluation.
[0028] Further, according to the above-mentioned method for analyzing the competition data in drug R & D, obtain the start and end date information of the R & D milestone stage in the drug clinical stage based on the drug clinical information table, specifically including:
[0029] Collect drug clinical information, and the clinical information includes: drug name, enterprise name, clinical registration number, clinical trial phase, clinical trial status, and the enrollment time of the first subject;
[0030] Determine the R & D milestone stage in the clinical stage based on the clinical trial phase;
[0031] Determine the earliest start date of the R & D milestone stage in the drug clinical stage based on the clinical trial phase and the enrollment date of the first subject;
[0032] Determine the earliest end date of the R & D milestone stage in the drug clinical stage based on the clinical trial phase and the clinical trial status,
[0033] Among them, collect the current clinical trial status at every preset time interval, compare it with the stored clinical trial status, judge whether there is a change. If there is a change, record the corresponding clinical trial status and the time when the current clinical trial status changes.
[0034] Further, according to the above-mentioned method for analyzing the competition data in drug R & D, obtain the start and end date information of the R & D milestone stage in the drug registration and listing stage based on the drug registration and listing information table, specifically including:
[0035] Collect drug registration and listing information, and the registration and listing information includes: drug name, enterprise name, acceptance number, application item, review conclusion, acceptance date, conclusion date, approval date;
[0036] Determine the R & D milestone stage in the drug registration and listing stage based on the application item and the review conclusion,
[0037] Determine the earliest start date of the R & D milestone stage in the drug registration and listing stage based on the application item and the acceptance date;
[0038] Determine the earliest end date of the R & D milestone stage in the drug registration and listing stage based on the application item, the review conclusion, the conclusion date and the approval date.
[0039] Further, according to the R & D information and the start and end date information of the drug R & D milestone stage, determine the R & D competition information of the target target and / or the target drug, specifically including:
[0040] Generate a bar chart with the first orthogonal axis as the date and the second orthogonal axis as the R & D information;
[0041] Any bar chart represents a specific R & D milestone stage;
[0042] The length direction of the bar chart is parallel to the first orthogonal axis;
[0043] The start and end of any bar chart respectively correspond to the start date and end date of the R & D milestone stage;
[0044] Sort the R & D information based on the first parameter value and the second parameter value, where the first parameter value is the R & D milestone stage and the second parameter value is the start date of the bar chart corresponding to the R & D milestone stage;
[0045] Determine the distance between the bar chart corresponding to each R & D information and the first orthogonal axis based on the sorting result.
[0046] In a second aspect, an embodiment of the present invention further provides a device for analyzing the R & D competition data of drugs, including:
[0047] Information acquisition module: Obtain a medical information query request, where the medical information includes target information and / or drug information;
[0048] First information query module: Obtain the R & D information corresponding to the medical information;
[0049] Second information query module: Obtain the start and end date information of the R & D milestone stage corresponding to the R & D information;
[0050] Information output module: Determine the R & D competition information of the target target and / or target drug according to the R & D information and the start and end date information of the R & D milestone stage of the drug.
[0051] Further, the first information query module is specifically used for:
[0052] The R & D information includes at least one of the R & D drug information of the innovative drugs corresponding to the target target, the R & D enterprise information of the innovative drugs corresponding to the target target, and the R & D enterprise information of the generic drugs corresponding to the target drug;
[0053] Among them, the R & D drug information is an information set of innovative drugs corresponding to the target target information obtained according to the target target and a pre-set relationship graph between the target and its corresponding drug information;
[0054] The R & D enterprise information is the R & D enterprise information set corresponding to the innovative drug and / or the generic drug under the target drug obtained based on the innovative drug information set and / or the target drug, and according to the drug information summary table;
[0055] Among them, the innovative drug and the generic drug are obtained according to the drug property type and the drug registration type;
[0056] The drug information summary table is obtained through the drug clinical information table and the drug registration and marketing information table;
[0057] Among them, the drug information summary table is obtained by merging the drug name information and enterprise information in the drug clinical information table and the drug registration and marketing information table.
[0058] Further, the second query module is specifically used for:
[0059] Obtain the start and end date information of the R & D milestone stage in the drug clinical stage based on the drug clinical information table,
[0060] Among them, the R & D milestone stage in the drug clinical stage includes at least one stage of BE test, Phase I clinical trial, Phase I / II clinical trial, Phase II clinical trial, Phase II / III clinical trial, and Phase III clinical trial;
[0061] Obtain the start and end date information of the R & D milestone stage in the drug registration and marketing stage based on the drug registration and marketing information table,
[0062] Among them, the R & D milestone stage in the drug registration and marketing stage includes at least one stage of clinical application, clinical approval, marketing application, marketing approval, application for consistency evaluation, and approval of consistency evaluation.
[0063] Further, the obtaining of the start and end date information of the R & D milestone stage in the drug clinical stage based on the drug clinical information table specifically includes:
[0064] Collect drug clinical information, and the clinical information includes: drug name, enterprise name, clinical registration number, clinical trial phase, clinical trial status, and the enrollment time of the first subject;
[0065] Determine the R & D milestone stage in the clinical stage based on the clinical trial phase;
[0066] Determine the earliest start date of the R & D milestone stage in the drug clinical stage based on the clinical trial phase and the enrollment date of the first subject;
[0067] Determine the earliest end date of the R & D milestone stage in the drug clinical stage based on the clinical trial phase and the clinical trial status,
[0068] The current clinical trial status is collected at preset time intervals and compared with the stored clinical trial status to determine whether there is a change. If there is a change, the corresponding clinical trial status is recorded, and the time when the current clinical trial status changes is recorded.
[0069] Furthermore, the start and end date information of the research and development milestone phases of the drug registration and marketing phases are obtained based on the drug registration and marketing information table, specifically including:
[0070] Collect drug registration and marketing information, including: drug name, company name, acceptance number, application matters, review conclusion, acceptance date, review conclusion date, and approval date;
[0071] Determine the R&D milestones for drug registration and marketing based on application matters and review conclusions.
[0072] Determine the earliest start date of the research and development milestones for drug registration and marketing based on the application details and acceptance date;
[0073] Based on the application matters, review conclusions, review completion date and approval date, determine the earliest end date of the R&D milestone stage of the drug registration and marketing stage.
[0074] Furthermore, the information output module is specifically used to:
[0075] Generate a bar chart with the date as the first orthogonal axis and the R&D information as the second orthogonal axis;
[0076] Each bar graph represents a specific R&D milestone stage;
[0077] The length direction of the bar graph is parallel to the first orthogonal axis;
[0078] The beginning and end of any bar graph correspond to the start date and end date of the R&D milestone phase, respectively;
[0079] Sorting the R&D information based on a first parameter value and a second parameter value, wherein the first parameter value is a R&D milestone stage, and the second parameter value is a start date of a bar chart corresponding to the R&D milestone stage;
[0080] The distance between the bar graph corresponding to each R&D information and the first orthogonal axis is determined based on the sorting result.
[0081] In a third aspect, an embodiment of the present invention further provides an electronic device, comprising: a memory, a processor, and a computer program stored in the memory and executable on the processor, wherein when the processor executes the program, the steps of the drug development competition data analysis method as described in any one of the above items are implemented.
[0082] In a fourth aspect, an embodiment of the present invention further provides a non-transitory computer-readable storage medium, on which a computer program is stored. When the computer program is executed by a processor, the steps of the method for analyzing pharmaceutical R & D competition data as described in any one of the above are implemented.
[0083] By using the method for analyzing pharmaceutical R & D competition data according to the embodiment of the present invention, by obtaining the R & D information corresponding to the pharmaceutical information and the start and end date information of the pharmaceutical R & D milestone stage corresponding to the R & D information, according to the R & D information and the start and end date information of the R & D milestone stage, the R & D progress competition information of the target target and / or target drug is determined, the progress of pharmaceutical R & D is reflected in a timely manner, enabling users to quickly obtain the R & D competition information of different innovative drugs under the target target and the R & D competition information of different generic drugs under the target drug. The data is updated in real time, greatly improving the efficiency of R & D data analysis. At the same time, the comprehensiveness and accuracy of the data are also greatly improved. BRIEF DESCRIPTION OF THE DRAWINGS
[0084] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for use in the description of the embodiments or the prior art. Obviously, the drawings in the following description are some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative efforts.
[0085] Figure 1 It is a schematic flowchart of a method for analyzing pharmaceutical R & D competition data provided by an embodiment of the present invention;
[0086] Figure 2 It is a schematic structural diagram of a device for analyzing pharmaceutical R & D competition data provided by an embodiment of the present invention;
[0087] Figure 3 It is a schematic physical structure diagram of an electronic device provided by an embodiment of the present invention;
[0088] Figure 4 It is an analysis diagram of a data source in a method for analyzing pharmaceutical R & D competition data provided by an embodiment of the present invention. DETAILED DESCRIPTION OF THE EMBODIMENTS
[0089] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are some, but not all, of the embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts fall within the scope of protection of the present invention.
[0090] Based on the method for analyzing the competition data of drug R & D described in the present invention, the embodiments thereof will be described in detail below. As Figure 1 shown, it is a flowchart of the method for analyzing the competition data of drug R & D provided by the embodiment of the present invention, and the specific implementation process includes the following steps:
[0091] Step 110: Obtain a medical information query request, where the medical information includes target information and / or drug information;
[0092] Specifically, the target target is a drug target, which refers to the binding site of a drug and a biological macromolecule of an organism, such as the PDI (Protein disulfide isomerase) target.
[0093] In the embodiment of the present invention, before obtaining the target target query request, it is necessary to pre - establish a knowledge graph of the association relationship between target information and drug information.
[0094] Step 120: Obtain the R & D information corresponding to the medical information;
[0095] The R & D information includes at least one of the R & D drug information of innovative drugs corresponding to the target target, the R & D enterprise information of innovative drugs corresponding to the target target, and the R & D enterprise information of generic drugs corresponding to the target drug;
[0096] Among them, the R & D drug information is an information set of innovative drugs corresponding to the target target information obtained according to the target target and a preset relationship graph between the target and its corresponding drug information;
[0097] The R & D enterprise information includes the enterprise information of those who are developing relevant drugs and the enterprise information of those whose relevant drugs have been listed;
[0098] Specifically, the R & D enterprise information is an information set of R & D enterprises corresponding to innovative drugs under the target target and / or generic drugs under the target drug obtained according to a total drug information table obtained based on the innovative drug information set and / or the target drug;
[0099] Among them, the innovative drugs and the generic drugs are obtained according to the drug property type and the drug registration type; the drug property type includes chemical drugs, biological products, and traditional Chinese medicines; the drug registration type is a refined classification of chemical drugs, biological products, and traditional Chinese medicines when submitting a registration application to the NMPA;
[0100] Further, the total drug information table is obtained through a drug clinical information table and a drug registration and listing information table;
[0101] Among them, the total drug information table is obtained by merging based on the drug name information and enterprise information in the drug clinical information table, drug registration and marketing information table.
[0102] Specifically, on the one hand, since drug clinical information is scattered in three major databases: the drug registration and registration database of the National Medical Products Administration (CDE), the Chinese drug clinical trial registration database, and ClinicalTrials, and drug registration and marketing information is scattered in the domestic and imported drug databases of the National Medical Products Administration (NMPA) and the drug registration and registration database of the National Center for Drug Evaluation (CDE). The information of these data sources intersects and partially overlaps, but is not completely contained.
[0103] On the other hand, there are issues such as joint R & D of drugs, transfer of clinical approvals or production approvals, and the marketing authorization holder system for drugs. The historical evolution is relatively complex, and the entities in different data sources will change.
[0104] Therefore, the drug clinical information is obtained by constructing the drug clinical information table, and the drug registration and marketing information is obtained by constructing the drug registration and marketing information table. Then, the drug clinical information table and the drug registration and marketing information table are merged through the drug name information and enterprise information to obtain the total drug information table, and further obtain the accurate and complete R & D enterprise information corresponding to the target drug, as well as the complete R & D progress information under the target drug.
[0105] Step 130: Obtain the start and end date information of the drug R & D milestone stage corresponding to the R & D information.
[0106] In this embodiment, for innovative drugs: the new drug R & D cycle is long and the investment is large. Enterprises need to closely monitor the development progress in this field and adjust strategies within several years. Financial practitioners also need to closely monitor the R & D progress and adjust the valuation model and investment. The drug application and clinical information can well display that the new drug R & D process includes pre-clinical research - application for clinical trial - Phase I - Phase II - Phase III - application for marketing - marketing. Therefore, new drug development needs to go through two rounds of processes: clinical application and marketing application.
[0107] For generic drugs: With the further advancement of volume-based procurement, the profit margins of the generic drug industry have been significantly compressed. Pharmaceutical companies need to plan carefully and rely on economies of scale and synergy effects to maintain the profit margins of their generic drug pipelines. Currently, there are two types of generic drug filings in China: (1) The consistency evaluation of already marketed drugs approved according to the old regulations; (2) The "deemed consistency application" conducted in accordance with the current reference preparations and equivalence standards. Generally, the launch of a generic drug requires two processes: equivalence study and marketing application. For the filing process of already marketed products: BE (bioequivalency) filing - BE study - consistency application - approval supplement; for the filing process of generic drugs with new chemical classifications: BE filing - BE study - marketing application - market launch; for the filing process of generic drugs with special dosage forms / high risks: clinical application - clinical study (Phase I, Phase II, Phase III) - marketing application - market launch;
[0108] In summary, the start and end date information of the R & D milestone stage corresponding to the R & D information of the drug actually includes the start and end date information of the R & D milestone stage in the clinical stage of the drug and the start and end date information of the R & D milestone stage in the registration and marketing stage of the drug;
[0109] Specifically, the start and end date information of the R & D milestone stage in the clinical stage of the drug is obtained based on the drug clinical information table,
[0110] Among them, the R & D milestone stage in the clinical stage of the drug includes at least one of the following stages: BE test, Phase I clinical trial, Phase I / II clinical trial, Phase II clinical trial, Phase II / III clinical trial, Phase III clinical trial;
[0111] The start and end date information of the R & D milestone stage in the registration and marketing stage of the drug is obtained based on the drug registration and marketing information table,
[0112] Among them, the R & D milestone stage in the registration and marketing stage of the drug includes at least one of the following stages: application for clinical trial, approval of clinical trial, application for marketing, approval of marketing, application for consistency evaluation, approval of consistency evaluation.
[0113] Furthermore, a drug clinical information table is constructed by collecting the original drug clinical information and the start date and end date of the R & D milestone stage in the clinical stage of the drug calculated based on the original drug clinical information. The original drug clinical information includes: drug name, company name, clinical registration number, clinical trial phase, clinical trial status, and the enrollment time of the first subject.
[0114] Specifically, due to multiple specifications and multiple indications of the same drug, a relatively large number of clinical trials may be carried out at the same time. Therefore, pre-aggregating the data by drug name, company name, and clinical trial phase avoids the system burden of calculating a much larger amount of data at the same time and improves the calculation efficiency.
[0115] Since the clinical research times of different clinical phases may not be sequential, time intersections and dislocations may occur. Therefore, based on the pre-aggregated data, determine the R & D milestone phases of the clinical stage based on the clinical trial phase; determine the earliest start date of the drug clinical stage milestone phase based on the clinical trial phase and the enrollment date of the first subject; determine the earliest end date of the R & D milestone phase of the drug clinical stage based on the clinical trial phase and the clinical trial status, where the current clinical trial status is collected at preset time intervals and compared with the stored clinical trial status to determine whether there is a change. If there is a change, record the corresponding clinical trial status and the time when the current clinical trial status changes.
[0116] Furthermore, construct a drug registration and marketing information table jointly by collecting the original drug registration and marketing information and the start date and end date of the R & D milestone phase of the drug registration and marketing stage calculated based on the original drug registration and marketing information. The original drug registration and marketing information includes: drug name, company information, acceptance number, application matters, review conclusion, acceptance date, conclusion date, approval date.
[0117] Specifically, based on the data of registered and marketed drugs in China. Among them, for the Chinese drug registration data, CDE manages it by acceptance number. For the same drug of the same company, there may be several or even thousands of acceptance number data; for the Chinese marketed drug data, NMPA manages it by drug approval number. For the same drug of the same company, there may be multiple or even dozens of drug approval number information, and the drug approval date, specifications, etc. of each piece of information are different.
[0118] Secondly, there are situations such as joint R & D of drugs, transfer of clinical approvals or production approvals, and the marketing authorization holder system for drugs, and the historical evolution is relatively complex, and the subjects in different data sources will change. Therefore, pre-aggregating the data by drug name and company name avoids the system burden of calculating a much larger amount of data at the same time and improves the calculation efficiency.
[0119] Therefore, based on the pre-aggregated data, determine the R & D milestone phases of the drug registration and marketing stage based on the application matters and review conclusions.
[0120] Determine the earliest start date of the R & D milestone phase of the drug registration and marketing stage based on the application matters and acceptance date.
[0121] Determine the earliest end date of the R & D milestone stage in the drug registration and listing stage based on the said application matters, review conclusions, conclusion dates, and approval dates.
[0122] Step 140: Determine the R & D competition information of the target target and / or target drug according to the said R & D information and the start and end date information of the drug R & D milestone stage.
[0123] Generate a bar chart with the first orthogonal axis as the date and the second orthogonal axis as the R & D information according to the said R & D information and the start and end date information of the drug R & D milestone stage;
[0124] Any bar chart represents a specific R & D milestone stage;
[0125] The length direction of the said bar chart is parallel to the first orthogonal axis;
[0126] The start and end of any bar chart respectively correspond to the start date and end date of the R & D milestone stage;
[0127] Specifically, the start and end of any bar chart can respectively correspond to the start date and end date of the same R & D milestone stage, or can respectively correspond to the end date and start date of different R & D milestones; for example, for the bar chart corresponding to the BE test in the R & D milestone stage, the start of the corresponding bar chart is the start date of the BE test, and the end of the corresponding bar chart is the end date of the BE test; for the bar chart corresponding to the application for listing in the R & D milestone stage, the start of the corresponding bar chart is the end date of the Phase III trial, and the end of the corresponding bar chart is the start date of the application for listing;
[0128] Further, sort the said R & D based on the first parameter value and the second parameter value, where the first parameter value is the R & D milestone stage and the second parameter value is the start date of the bar chart corresponding to the R & D milestone stage;
[0129] Determine the distance between the bar chart corresponding to each R & D information and the first orthogonal axis based on the sorting result.
[0130] Specifically, the R & D information on the second orthogonal axis includes at least one of the R & D drug name corresponding to the innovative drug under the target target, the R & D enterprise name corresponding to the innovative drug under the target target, and the R & D enterprise name corresponding to the generic drug under the target drug. Among them, for the R & D enterprise name corresponding to the innovative drug under the target target, there is a situation where multiple innovative drugs corresponding to the target target are developed by the same enterprise. Therefore, it is necessary to sort the R & D enterprises corresponding to different innovative drugs under the target target on the second orthogonal axis. It can be distinguished by marking the same R & D enterprise corresponding to different innovative drugs, or by marking the innovative drug names corresponding to the same R & D enterprise, or other markings can be used for distinction. This embodiment does not make specific limitations here.
[0131] Based on the above embodiments, step 120 includes:
[0132] The R & D drug information obtains an innovative drug information set corresponding to the target information according to the target information and a pre-set relationship map between the target and its corresponding drug information; for example,
[0133]
[0134] The R & D enterprise information is an R & D enterprise information set corresponding to innovative drugs under the target and / or generic drugs under the target drug obtained according to a total drug information table corresponding to the innovative drug information set and / or the target drug;
[0135] Wherein, the total drug table includes: drug name, enterprise name, innovation type, start date and end date information of each R & D milestone stage under the target drug;
[0136] For example,
[0137]
[0138] Specifically, through the innovation type being innovative drugs, the R & D progress of all innovative drugs under the target can be obtained, and the R & D progress of the R & D enterprises corresponding to all innovative drugs under the target can also be obtained; through the innovation type being generic drugs, the R & D progress of all generic drug R & D enterprises under the target drug can be obtained;
[0139] Wherein, the judgment of the drug innovation type is obtained based on the drug property type and the drug registration type; for example, if the drug property type of the target drug is a chemical drug and the drug registration type is type 1 or 1.1 or 1.2 or 5.1, then mark the innovation type of the drug as an innovative drug; if the drug property type of the target drug is a chemical drug and the drug registration type is type 3 or 3.1 or 4 or 5.2 or 6, then mark the innovation type of the drug as a generic drug; if the drug property type of the target drug is a biological product and the drug registration type is type 1 or 6 or 8 or 9, then mark the innovation type of the drug as an innovative drug;
[0140] Furthermore, the total drug information table is obtained through a drug clinical information table and a drug registration and marketing information table;
[0141] Among them, a drug clinical information table is jointly constructed by collecting the original drug clinical information and calculating the start date and end date of the R & D milestone stage in the drug clinical stage based on the original drug clinical information; a drug registration and listing information table is communicated and constructed by collecting the original drug registration and listing information and calculating the start date and end date of the R & D milestone in the drug registration and listing stage based on the original drug registration and listing information;
[0142] Specifically, the collected original drug clinical information table includes: drug name, enterprise name, clinical registration number, clinical trial phase, clinical trial status, the time when the first subject is enrolled. For example,
[0143]
[0144] Specifically,
[0145] For drug information: For the clinical research data registered on the CDE platform, the drug name can be directly extracted. For some of the clinical trial data registered in the Chinese Drug Clinical Trial Registration Database, the research name needs to be extracted, such as, "An open, multicenter Phase IV clinical study to evaluate the efficacy and safety of Shezhi Shenhuang Ointment in the treatment of superficial mycosis; An open, multicenter Phase IV clinical study to evaluate the efficacy and safety of Shezhi Shenhuang Ointment in the treatment of superficial mycosis", and then the drug name is further extracted through entity recognition or rule-based matching; the extracted drug name is matched in a preset drug dictionary to obtain the standard drug name and store it.
[0146] For enterprise information: The enterprise name is directly extracted from the official website and matched in a preset enterprise dictionary to obtain the standard enterprise name and store it;
[0147] For the trial phase information: The trial phase corresponding to the target clinical registration number is obtained from the official website. The clinical registration number is the unique code identified by the official for each registered clinical trial. The trial phases include: Phase I (such as, Phase I, Phase Ib, Phase Ia), Phase I / II (such as, Phase I / II, Phase Ib / II), Phase II (such as, Phase II, Phase IIa, Phase II / III), Phase II / III (such as, Phase II / III), Phase III (such as, Phase III, Phase IIIa), BE trial;
[0148] Based on the trial phase obtained from the official website, the standard trial phase is obtained by cleaning according to certain rules. For example,
[0149]
[0150] For the trial status information: Obtain the trial status corresponding to the target clinical registration number from the official website. The trial status includes: In progress (not yet recruiting), In progress (recruiting), In progress (recruitment completed), Completed, Suspended or terminated voluntarily, Halted; Based on the trial status obtained from the official website, clean it according to certain rules to obtain the standard trial status. For example, if the collected trial status starts with "Suspended voluntarily" or "Terminated voluntarily", return "Suspended or terminated voluntarily"; if the collected trial status starts with "Ordered to suspend" or "Ordered to terminate", return "Halted".
[0151] Since the trial status is a continuously changing process, therefore, collect the current clinical trial status at preset time intervals. The time interval can be 1 day, 3 days, and this embodiment does not make specific limitations here; Compare the current clinical trial status with the stored clinical trial status to determine whether there is a change. If there is a change, record the corresponding clinical trial status, and use the time when the current trial status changes as the time when the clinical trial status changes, and store it.
[0152] For the information on the enrollment date of the first subject: Obtain the domestic enrollment date of the first subject and the foreign enrollment date of the first subject corresponding to the target clinical registration number from the official website. For the enrollment date of the first subject, preferentially obtain the domestic enrollment date of the first subject. If the domestic enrollment date of the first subject is empty, use the foreign enrollment date of the first subject as the enrollment date of the first subject.
[0153] Furthermore, calculate the start date and end date of the R & D milestone stage of the target drug in the clinical stage based on the clinical trial phase, the enrollment date of the first subject, and the clinical trial status. For example: BE trial start date, BE trial end date, Phase I trial start date, Phase I trial end date, I / II trial start date, I / II trial end date, Phase II trial start date, Phase II trial end date, II / III trial start date, II / III trial end date, Phase III trial start date, Phase III trial end date. Save the collected drug clinical information and the start date and end date of the R & D milestone stage of the drug clinical stage together in the drug clinical information table.
[0154] The collected original drug registration and marketing information includes: The collected original drug registration information, including: drug name, company name, acceptance number, application item, review conclusion, acceptance date, conclusion date, and the collected original drug marketing information, including: drug name, company name, approval number, approval date;
[0155] Among them, the collected original drug registration information, such as,
[0156]
[0157] Specifically,
[0158] Regarding enterprise information: On the one hand, drug registration information will be separately registered on two official platforms, CDE and NMPA. For example, the application matters corresponding to the target acceptance number for drugs will be registered on the CDE platform, and the review conclusion matters corresponding to the target acceptance number for drugs will be registered on the NMPA platform. On the other hand, there are issues such as joint R & D of drugs, transfer of clinical approvals or production approvals, and the marketing authorization holder system, with a relatively complex historical evolution, and the entities in the two data sources of CDE and NMPA will change; Therefore, based on the same acceptance number, the enterprise information from the two data sources is merged and cleaned. For example, special characters are removed, duplicates are removed, etc.; The merged enterprise names are matched in a pre-constructed enterprise dictionary to obtain standard enterprise names and stored;
[0159] Regarding drug name information: From any one of the official platforms of CDE and NMPA, the drug name corresponding to the acceptance number is extracted, and it is matched in a pre-constructed drug dictionary to obtain a standard drug name and stored.
[0160] Regarding application matter information: The application matter is obtained by judging the acceptance number through a preset rule, where the acceptance number is an operation mark used by the National Medical Products Administration for the approval of the accepted drug registration application; For example, when the acceptance number starts with JT, the application matter is JT, indicating: one-time import; When the acceptance number starts with CQZ or JQZ or CSZ or JSZ, the application matter is S, indicating: application for production; For others, the fourth character of the acceptance number is taken as the value of the application matter, such as L, indicating: application for clinical trial;
[0161] Regarding review conclusion information:
[0162] First, initialize the review conclusion information to "not available yet";
[0163] Second, determine the corresponding review conclusion (such as review conclusion A or review conclusion B) based on the collected information, and then compare it with the stored review conclusion to judge whether there is a change. If there is a change, record the corresponding review conclusion and store it. For example,
[0164] (1) If the information on the clinical trial notice letter issuance directory is collected and the stored review conclusion information is not available yet, then determine the review conclusion as approved for clinical trial;
[0165] (2) If the information on marketed drugs (including the technical review report and the product label) is collected and the stored review conclusion information is not available yet, then determine the review conclusion as approved for production;
[0166] (3)If the information of waiting to receive the new license by replacing the old one for a specific drug is collected and the stored review conclusion information is "not available yet", when the head of the acceptance number being detected is in the fields of JYHB, JYSB, JYZB, JYBB or JYFB, the review conclusion will be determined as "approved supplement"; when the head of the acceptance number being detected is in the fields of JYBZ, JYHZ, JYFZ, JYSZ or JYZZ, the review conclusion will be determined as "approved re-registration".
[0167] Regarding the acceptance date information:
[0168] Directly obtain the acceptance date corresponding to the target acceptance number through the CDE official website, and obtain the target date through data cleaning and format conversion. However, there may be a situation where the acceptance date on the CDE official website is a null value.
[0169] Collect the processing status corresponding to the target acceptance number on the NMPA official website every preset time. The preset time can be 1 day, 3 days, and this embodiment does not make specific limitations here; the processing status includes: "waiting for acceptance", "accepted - waiting for review", "under review", "review completed - waiting for license printing", "under approval", "approval completed - waiting for license printing"; initialize the processing status as a null value, compare the currently collected processing status with the stored data. If there is a change, it means that the currently collected processing status has changed. If the currently collected processing status is "accepted", collect the "status start date" corresponding to the target acceptance number, obtain the target date through data cleaning and format conversion, and store it in the "undertaking date" information; if the above "status start date" is a null value, store the date when the currently collected processing status changes to "accepted" in the "undertaking date" information.
[0170] The acceptance date preferentially obtains the acceptance date corresponding to the target acceptance number directly through the CDE official website; if the acceptance date corresponding to the target acceptance number on the CDE official website is a null value, obtain the date in the "undertaking date" information.
[0171] Regarding the conclusion date information:
[0172] Collect the processing status on the NMPA official website every preset time. The preset time can be 1 day, 3 days, and this embodiment does not make specific limitations here; if the currently collected processing status is "approval completed - waiting for license printing", use the current data collection date as the conclusion date.
[0173] If the review completion date obtained based on the above steps is a null value, the review task progress of the target acceptance number in the "New Material Task Publicity" and "Supplementary Material Task Publicity" on the CDE official website is collected at preset intervals. The preset time can be 1 day or 3 days, and this embodiment does not make specific restrictions here; if all review items corresponding to the target acceptance number are shown to have been reviewed, the latest collection date of the target acceptance number in the "New Material Task Publicity" and "Supplementary Material Task Publicity" when all review items are shown to have been reviewed is obtained as the review completion date;
[0174] Regarding the application for consistency evaluation:
[0175] The consistency evaluation application status includes: application for consistency evaluation, deemed application for consistency evaluation, and non-consistency evaluation application; obtaining a consistency evaluation list from the CDE official website at preset intervals, the preset time may be 1 day or 3 days, and this embodiment does not make specific limitations here; if the target acceptance number is in the consistency evaluation list, the consistency evaluation application status corresponding to the target acceptance number is application for consistency evaluation;
[0176] If the drug property type corresponding to the target acceptance number is chemical drug, the drug registration type is Class 3, Class 4, Class 5.2, and the application item corresponding to the target acceptance number is S, then the consistency evaluation application corresponding to the target acceptance number is deemed to be applied for consistency evaluation;
[0177] If it is neither of the above two situations, the consistency evaluation application corresponding to the target acceptance number is a non-consistency evaluation application;
[0178] Regarding the consistency evaluation results:
[0179] The consistency evaluation pass status includes: non-consistency evaluation, passed, applying, deemed to be applied, and not approved;
[0180] If the consistency evaluation application status corresponding to the target acceptance number is a non-consistency evaluation application, then the consistency evaluation status corresponding to the target acceptance number is: non-consistency evaluation;
[0181] If the consistency evaluation application status corresponding to the target acceptance number is an application for consistency evaluation or deemed to be an application for consistency evaluation, the consistency evaluation pass status is further obtained based on the collected review conclusions; for example, if the review conclusion corresponding to the target acceptance number includes "approval", such as approval for production or approval for supplementation, the consistency evaluation pass status corresponding to the target acceptance number is passed;
[0182] The original drug marketing information collected, such as:
[0183]
[0184] For enterprise information: obtain the enterprise name corresponding to the approval number based on NMPA and clean it, such as removing special characters; match the enterprise name based on the information in the pre-built enterprise dictionary to obtain the standard enterprise name and store it;
[0185] Regarding drug name information: obtain the drug name corresponding to the approval number based on NMPA, and match it with the pre-built drug dictionary to obtain the standard drug name and store it.
[0186] Regarding the approval date: Based on the approval date corresponding to the approval document number obtained from NMPA, the date format is converted to obtain and store the date information in the standard format.
[0187] Furthermore, the collected original drug registration information and original drug marketing information are aggregated based on the same drug name, the same or partially identical company name, and the start date and end date of the research and development milestone stage of the target drug registration and marketing stage are calculated based on the application matters, review conclusions, review completion date and approval date, such as the date of application for consistency evaluation, the date of passing the consistency evaluation, the date of application for clinical trials, the date of approval for clinical trials, the date of application for marketing, and the date of approval for marketing; the aggregated drug registration information and drug marketing information, as well as the start date and end date of the research and development milestone stage of the drug registration and marketing stage are saved together in the drug registration and marketing information table.
[0188] Furthermore, based on the same drug name, same company name or part of the same drug name, the drug clinical information table and the drug registration and marketing information table are merged to obtain a drug information summary table;
[0189] Based on the above, a complete R&D enterprise information set corresponding to the innovative drugs under the target and / or the generic drugs under the target drugs can be obtained.
[0190] Step 130 includes:
[0191] Obtaining the start and end date information of the drug research and development milestone stages corresponding to the research and development information, including the start and end dates of the drug clinical stage research and development milestone stages obtained based on the original drug clinical information, and the start and end dates of the drug registration and marketing stage research and development milestone stages obtained based on the original drug registration and marketing information;
[0192] Specifically, the start date and end date of the R & D milestone stage in the clinical stage of the drug include at least one of the following dates: the start date of the BE trial, the end date of the BE trial, the start date of the Phase I trial, the end date of the Phase I trial, the start date of the Phase I / II trial, the end date of the Phase I / II trial, the start date of the Phase II trial, the end date of the Phase II trial, the start date of the Phase II / III trial, the end date of the Phase II / III trial, the start date of the Phase III trial, and the end date of the Phase III trial;
[0193] Furthermore, based on the clinical trial phases, the enrollment date of the first subject, and the clinical trial status, the start date and end date of the R & D milestone stage of the target drug in the clinical stage are calculated;
[0194] Specifically, regarding the start time and end time of the BE trial:
[0195] Based on the same drug name, the same company name, and the experimental phase being BE, the data is pre-aggregated to obtain the target dataset;
[0196] The earliest time corresponding to the trial status of "completed" or "ended" in the target dataset is obtained as the end time of the BE trial;
[0197] The clinical registration number corresponding to the above end time of the BE trial is obtained, and the enrollment date of the first subject corresponding to the target clinical registration number is the start time of the BE trial;
[0198] If the enrollment date of the first subject corresponding to the above target clinical registration number is a null value, the earliest enrollment date of the first subject in the target dataset is obtained as the start date of the BE trial;
[0199] Regarding the start and end times of the Phase I clinical trial:
[0200] Based on the same drug name, the same company name, and the experimental phase being Phase I, the data is pre-aggregated to obtain the target dataset;
[0201] The earliest enrollment date of the first subject in the target dataset is obtained as the start date of the Phase I trial;
[0202] The earliest time corresponding to the trial status of "completed" or "ended" in the target dataset is obtained as the end time of the Phase I trial;
[0203] Regarding the start and end dates of the Phase I / II clinical trial:
[0204] Based on the same drug name, the same company name, and the experimental phase being Phase I / II, the data is pre-aggregated to obtain the target dataset;
[0205] The enrollment date of the earliest first subject in the target dataset is taken as the start date of the Phase I / II trial;
[0206] In the target dataset, the earliest time corresponding to the trial status of "completed" or "ended" is taken as the end date of the Phase I / II trial;
[0207] Regarding the start and end times of the Phase II clinical trial:
[0208] Based on the same drug name, the same company name, and the experimental phase of Phase II, the data is pre-aggregated to obtain the target dataset;
[0209] The enrollment date of the earliest first subject in the target dataset is taken as the start date of the Phase II trial;
[0210] In the target dataset, the earliest time corresponding to the trial status of "completed" or "ended" is taken as the end date of the Phase II trial;
[0211] Regarding the start and end times of the Phase II / III clinical trial:
[0212] Based on the same drug name, the same company name, and the experimental phase of Phase II / III, the data is pre-aggregated to obtain the target dataset;
[0213] The enrollment date of the earliest first subject in the target dataset is taken as the start date of the Phase II / III trial;
[0214] In the target dataset, the earliest time corresponding to the trial status of "completed" or "ended" is taken as the end date of the Phase II / III trial;
[0215] Regarding the start and end times of the Phase III clinical trial:
[0216] Based on the same drug name, the same company name, and the experimental phase of Phase III, the data is pre-aggregated to obtain the target dataset;
[0217] The enrollment date of the earliest first subject in the target dataset is taken as the start date of the Phase III trial;
[0218] In the target dataset, the earliest time corresponding to the trial status of "completed" or "ended" is taken as the end date of the Phase III trial;
[0219] Furthermore, the start date and end date of the R & D milestone stage in the drug registration and marketing stage include at least one of the following dates: the date of applying for clinical trial, the date of approval for clinical trial, the date of applying for marketing, the date of approval for marketing, the date of applying for consistency evaluation, and the date of approval for consistency evaluation;
[0220] Specifically, the start and end dates of the R & D milestone stage in the drug registration and listing phases are calculated based on the application matters, review conclusions, conclusion dates, and approval dates;
[0221] First, pre-aggregate the collected original drug registration data and original drug listing data based on the same drug name, the same or partially the same enterprise name to obtain a drug registration and listing aggregation data table;
[0222] Regarding the application clinical date information:
[0223] Based on the drug registration and listing aggregation data table, obtain the target data set with the application matter being L, and obtain the date information with the earliest acceptance date in the target data set as the application clinical date;
[0224] Regarding the approved clinical date information:
[0225] Based on the drug registration and listing aggregation data table, obtain the target data set with the application matter being L or R and the review conclusion being approved for clinical trials, and obtain the date with the earliest conclusion date in the target data set as the approved clinical date;
[0226] Regarding the application for listing date information:
[0227] Based on the drug registration and listing aggregation data table, obtain the target data set with the application matter being S, and obtain the date information with the earliest acceptance date in the target data set as the application for listing date;
[0228] Regarding the approved listing date information:
[0229] Based on the drug registration and listing aggregation data table, obtain the date with the earliest approval date as the approved listing date;
[0230] Regarding the application for consistency evaluation time information:
[0231] Based on the drug registration and listing aggregation data table, obtain the target data set with the consistency evaluation application status being application for consistency evaluation or deemed application for consistency evaluation, and obtain the date information with the earliest acceptance date in the target data set as the application for consistency evaluation time;
[0232] Regarding the time information for passing the consistency evaluation:
[0233] Based on the drug registration and listing aggregation data table, obtain the target data set with the consistency evaluation passing status being passed, and obtain the date with the earliest conclusion date in the target data set as the time for passing the consistency evaluation;
[0234] Furthermore, based on the R & D progress logical relationship, rules can be set to judge whether the above 4 date information is reasonable for the application clinical date, approved clinical date, application for listing date, and approved listing date obtained in the above steps. For example,
[0235] (1) If "Approval Clinical Date < Application Clinical Date", then clear the Application Clinical Date of this acceptance number;
[0236] (2) If "Application for Marketing Date < Approval Clinical Date", then clear the Approval Clinical Date of this acceptance number;
[0237] (3) If "Application for Marketing Date < Application Clinical Date", then clear the Application Clinical Date of this acceptance number;
[0238] (4) If "Approval for Marketing Date < Application for Marketing Date", then clear the Application for Marketing Date of this acceptance number;
[0239] (5) If "Approval for Marketing Date < Approval Clinical Date", then clear the Approval Clinical Date of this acceptance number;
[0240] (6) If "Approval for Production Date < Application Clinical Date", then clear the Application Clinical Date of this acceptance number;
[0241] Furthermore, based on any change in the application matter, review conclusion, or conclusion date in the drug registration and marketing information table, the start and end dates of the R & D milestone stage in the drug registration and marketing stage are synchronously updated.
[0242] Step 140 includes:
[0243] Generate a bar chart with the first orthogonal axis as the date and the second orthogonal axis as the R & D information according to the R & D information and the start and end date information of the drug R & D milestone stage; any bar chart represents a specific R & D milestone stage; the length direction of the bar chart is parallel to the first orthogonal axis;
[0244] The start and end of any bar chart respectively correspond to the start date and end date of the R & D milestone stage;
[0245] Specifically, for innovative drugs under the target target: the R & D milestone stage includes any stage among Application for Clinical, Approval for Clinical, Phase I Clinical, Phase I / II Clinical, Phase II Clinical, Phase II / III Clinical, Phase III Clinical, Application for Marketing, and Approval for Marketing according to the R & D progress;
[0246] For generic drugs under the target drug: the R & D milestone stage includes any stage among Application for Clinical, Approval for Clinical, BE Test, Phase I Clinical, Phase I / II Clinical, Phase II Clinical, Phase II / III Clinical, Phase III Clinical, Application for Marketing, Approval for Marketing, Application for Consistency Evaluation, and Passing Consistency Evaluation according to the R & D progress;
[0247] The start and end of any bar graph can respectively correspond to the start date and end date of the same R & D milestone stage, or can respectively correspond to the end date and start date of different R & D milestones; for example, for the bar graph corresponding to the BE trial in the R & D milestone stage, the start of the bar graph is the start date of the BE trial, and the end of the corresponding bar graph is the end date of the BE trial; for the bar graph corresponding to the application for marketing in the R & D milestone stage, the start of the bar graph is the end date of the Phase III clinical trial, and the end of the corresponding bar graph is the start date of the application for marketing;
[0248] Further, sort the R & D based on the first parameter value and the second parameter value, where the first parameter value is the R & D milestone stage, and the second parameter value is the start date of the bar graph corresponding to the R & D milestone stage;
[0249] Determine the distance between the bar graph corresponding to each R & D information and the first orthogonal axis based on the sorting result.
[0250] Specifically, based on the different R & D progress of innovative drugs and generic drugs, if any R & D information among the R & D drug information of the innovative drug corresponding to the target target, the R & D enterprise information of the innovative drug corresponding to the target target, and the R & D enterprise information of the generic drug corresponding to the target drug has an earlier R & D milestone stage and an earlier start date of the bar graph corresponding to this R & D milestone, then the distance between the bar graph corresponding to the target R & D information and the first orthogonal axis is farther.
[0251] Furthermore, this solution can not only be used for the analysis of domestic drug R & D competition data, but also analyze foreign or global data by country or region.
[0252] By using the method for analyzing drug R & D competition data described in the embodiments of the present invention, by obtaining the R & D information corresponding to the medical information and the date information of the drug R & D milestone stage corresponding to the R & D information, and according to the R & D information and the start and end date information of the R & D milestone stage, determine the R & D progress competition information of the target target and / or the target drug, timely reflect the progress of drug R & D, enable users to quickly obtain the R & D competition information of different innovative drugs under the target target and the R & D competition information of different generic drugs under the target drug, with real-time data update, greatly improving the efficiency of R & D data analysis, and at the same time, the comprehensiveness and accuracy of the data are also greatly improved.
[0253] Corresponding to the above-provided method for analyzing drug R & D competition data, the present invention also provides a device for analyzing drug R & D competition data. Since the embodiments of this device are similar to the above method embodiments, the description is relatively simple. For the relevant parts, please refer to the description in the above method embodiment section. The following description of the embodiments of the device for analyzing drug R & D competition data is only illustrative. Please refer to Figure 2As shown in the figure, it is a schematic structural diagram of a pharmaceutical R & D competition data analysis device provided by an embodiment of the present invention.
[0254] A pharmaceutical R & D competition data analysis device according to the present invention specifically includes the following parts:
[0255] Information acquisition module 210: acquires a medical information query request, and the medical information includes target information and / or drug information;
[0256] First information query module 220: acquires R & D information corresponding to the medical information;
[0257] Second information query module 230: acquires start and end date information of the drug R & D milestone stage corresponding to the R & D information;
[0258] Information output module 240: determines R & D competition information of the target target and / or target drug according to the R & D information and the start and end date information of the drug R & D milestone stage.
[0259] By using the pharmaceutical R & D competition data analysis device described in the embodiment of the present invention, by acquiring R & D information corresponding to medical information and start and end date information of the drug R & D milestone stage corresponding to the R & D information, according to the R & D information and the start and end date information of the R & D milestone stage, the R & D progress competition information of the target target and / or target drug is determined, the progress of drug R & D is reflected in a timely manner, enabling users to quickly obtain R & D competition information of different innovative drugs under the target target and R & D competition information of different generic drugs under the target drug. The data is updated in real time, greatly improving the efficiency of R & D data analysis. At the same time, the comprehensiveness and accuracy of the data are also greatly improved.
[0260] Corresponding to the above-provided pharmaceutical R & D competition data analysis method, the present invention also provides an electronic device. Since the embodiment of this electronic device is similar to the above method embodiment, the description is relatively simple. For related parts, please refer to the description in the above method embodiment part. The following-described electronic device is only illustrative. For example Figure 3As shown, it is a schematic structural diagram of an electronic device disclosed in an embodiment of the present invention. The electronic device may include: a processor 301, a memory 302, and a communication bus 303. Among them, the processor 301 and the memory 302 communicate with each other through the communication bus 303. The processor 301 can call the logical instructions in the memory 302 to execute the method for analyzing the competition data of drug research and development. The method includes: obtaining a medical information query request, where the medical information includes target information and / or drug information; obtaining the research and development information corresponding to the medical information; obtaining the start and end date information of the drug research and development milestone stage corresponding to the research and development information; and determining the research and development competition information of the target target and / or target drug according to the research and development information and the start and end date information of the drug research and development milestone stage.
[0261] In addition, when the logical instructions in the above-mentioned memory 302 are implemented in the form of software functional units and sold or used as independent products, they can be stored in a computer-readable storage medium. Based on such an understanding, the technical solution of the present invention, in essence, or the part that contributes to the prior art, or a part of this technical solution, can be embodied in the form of a software product. The computer software product is stored in a storage medium and includes several instructions for causing a computer device (which may be a personal computer, a server, or a network device, etc.) to execute all or part of the steps of the methods described in the various embodiments of the present invention. The foregoing storage medium includes: various media such as USB flash drives, mobile hard disks, read-only memories (ROM, Read-Only Memory), random access memories (RAM, Random Access Memory), magnetic disks, or optical discs that can store program codes.
[0262] On the other hand, an embodiment of the present invention also provides a computer program product. The computer program product includes a computer program stored on a non-transitory computer-readable storage medium. The computer program includes program instructions. When the program instructions are executed by a computer, the computer can execute the method for analyzing the competition data of drug research and development provided in each of the above method embodiments. The method includes: obtaining a medical information query request, where the medical information includes target information and / or drug information; obtaining the research and development information corresponding to the medical information; obtaining the start and end date information of the drug research and development milestone stage corresponding to the research and development information; and determining the research and development competition information of the target target and / or target drug according to the research and development information and the start and end date information of the drug research and development milestone stage.
[0263]
[0264] In another aspect, an embodiment of the present invention further provides a non-transitory computer-readable storage medium, on which a computer program is stored. When the computer program is executed by a processor, it is configured to execute the method for analyzing the competition data of drug research and development provided in the above embodiments. The method includes: obtaining a medical information query request, where the medical information includes target information and / or drug information; obtaining the research and development information corresponding to the medical information; obtaining the start and end date information of the drug research and development milestone stage corresponding to the research and development information; and determining the research and development competition information of the target target and / or target drug according to the research and development information and the start and end date information of the drug research and development milestone stage.
[0265] The device embodiments described above are merely illustrative. The units described as separate components may or may not be physically separated, and the components shown as units may or may not be physical units, that is, they may be located in one place, or may be distributed to multiple network units. Some or all of the modules can be selected according to actual needs to achieve the purpose of the solution of this embodiment. Those of ordinary skill in the art can understand and implement it without creative efforts.
[0266] Through the description of the above embodiments, those skilled in the art can clearly understand that each embodiment can be implemented by means of software plus a necessary general hardware platform, and of course, it can also be implemented by hardware. Based on this understanding, the above technical solution, in essence, or the part that contributes to the prior art, can be embodied in the form of a software product. The computer software product can be stored in a computer-readable storage medium, such as ROM / RAM, magnetic disk, optical disk, etc., and includes several instructions for causing a computer device (which can be a personal computer, a server, or a network device, etc.) to execute the methods described in each embodiment or some parts of the embodiments.
[0267] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit them. Although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that they can still modify the technical solutions described in the foregoing embodiments, or equivalently replace some of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.
Claims
1. A method for analyzing drug R & D competition data, characterized in that Including: Obtaining a medical information query request, where the medical information includes target information and / or drug information; Obtaining R & D information corresponding to the medical information; The R & D information includes R & D drug information and R & D enterprise information of innovative drugs corresponding to the target target, and R & D enterprise information of generic drugs corresponding to the target drug; Obtaining start and end date information of the drug R & D milestone stage corresponding to the R & D information; Sorting the R & D information based on a first parameter value and a second parameter value, where the first parameter value is the R & D milestone stage and the second parameter value is the start date of the bar chart corresponding to the R & D milestone stage; determining the distance between the bar chart corresponding to each R & D information and the first orthogonal axis based on the sorting result; any bar chart represents a specific R & D milestone stage; the length direction of the bar chart is parallel to the first orthogonal axis; the start and end of any bar chart correspond to the start date and end date of the R & D milestone stage respectively; Among them, the obtaining of the start and end date information of the drug R & D milestone stage corresponding to the R & D information specifically includes: obtaining the start and end date information of the R & D milestone stage of the drug clinical stage based on the drug clinical information table; obtaining the start and end date information of the R & D milestone stage of the drug registration and listing stage based on the drug registration and listing information table; Among them, the obtaining of the start and end date information of the R & D milestone stage of the drug clinical stage based on the drug clinical information table specifically includes: collecting drug clinical information, where the clinical information includes: drug name, enterprise name, clinical registration number, clinical trial phase, clinical trial status, the time of enrollment of the first subject; determining the R & D milestone stage of the clinical stage based on the clinical trial phase; determining the earliest start date of the R & D milestone stage of the drug clinical stage based on the clinical trial phase and the enrollment date of the first subject; determining the earliest end date of the R & D milestone stage of the drug clinical stage based on the clinical trial phase and the clinical trial status; among them, the current clinical trial status is collected at preset time intervals and compared with the stored clinical trial status to determine whether there is a change. If there is a change, the corresponding clinical trial status is recorded, and the time when the current clinical trial status changes is recorded.
2. The method for analyzing the competition data of drug R & D according to claim 1, wherein The R & D drug information is an innovative drug information set corresponding to the target target information obtained according to the target target and a preset relationship map between the target and its corresponding drug information; The R & D enterprise information is an R & D enterprise information set corresponding to the innovative drug under the target target and / or the generic drug under the target drug obtained according to the total drug information table obtained according to the innovative drug information set and / or the target drug; Among them, the innovative drug and the generic drug are obtained according to the drug property type and drug registration type.
3. The method for analyzing the competition data of drug research and development according to claim 2, wherein The total drug information table is obtained through the drug clinical information table and the drug registration and listing information table; Among them, the total drug information table is obtained by merging the drug name information and enterprise information in the drug clinical information table and the drug registration and listing information table.
4. The method for analyzing the competition data of drug R & D according to claim 1, wherein The R & D milestone stages in the clinical stage of the drug include at least one of the following stages: BE test, Phase I clinical trial, Phase I / II clinical trial, Phase II clinical trial, Phase II / III clinical trial, and Phase III clinical trial; the R & D milestone stages in the drug registration and marketing stage include at least one of the following stages: application for clinical trial, approval of clinical trial, application for marketing, approval of marketing, application for consistency evaluation, and approval of consistency evaluation.
5. The method for analyzing the competition data of drug R & D according to claim 1, wherein Based on the drug registration and marketing information form, obtain the start and end date information of the R & D milestone stages in the drug registration and marketing stage, specifically including: Collect drug registration and marketing information, where the registration and marketing information includes: drug name, company name, acceptance number, application item, review conclusion, acceptance date, conclusion date, and approval date; Based on the application item and review conclusion, determine the R & D milestone stages in the drug registration and marketing stage; Based on the application item and acceptance date, determine the earliest start date of the R & D milestone stages in the drug registration and marketing stage; Based on the application item, review conclusion, conclusion date, and approval date, determine the earliest end date of the R & D milestone stages in the drug registration and marketing stage.
6. A pharmaceutical R & D competition data analysis device, characterized in that, Including: Information acquisition module: Obtain a medical information query request, where the medical information includes target information and / or drug information; First information query module: Obtain the R & D information corresponding to the medical information; the R & D information includes the R & D drug information and R & D company information of innovative drugs corresponding to the target, and the R & D company information of generic drugs corresponding to the target drug; Second information query module: Based on the drug clinical information form, obtain the start and end date information of the R & D milestone stages in the drug clinical stage; based on the drug registration and marketing information form, obtain the start and end date information of the R & D milestone stages in the drug registration and marketing stage; The method for obtaining the start and end date information of the R & D milestone stages in the drug clinical stage based on the drug clinical information form specifically includes: collecting drug clinical information, where the clinical information includes: drug name, company name, clinical registration number, clinical trial phase, clinical trial status, and the time of enrollment of the first subject; based on the clinical trial phase, determine the R & D milestone stages in the clinical stage; based on the clinical trial phase and the enrollment date of the first subject, determine the earliest start date of the R & D milestone stages in the drug clinical stage; based on the clinical trial phase and clinical trial status, determine the earliest end date of the R & D milestone stages in the drug clinical stage; among them, collect the current clinical trial status at preset time intervals, compare it with the stored clinical trial status, determine whether there is a change, if there is a change, record the corresponding clinical trial status, and record the time when the current clinical trial status changes; Information output module: Sort the R & D information based on the first parameter value and the second parameter value, where the first parameter value is the R & D milestone stage, and the second parameter value is the start date of the bar chart corresponding to the R & D milestone stage; Determine the distance between the bar chart corresponding to each R & D information and the first orthogonal axis based on the sorting result; Any bar chart represents a specific R & D milestone stage; The length direction of the bar chart is parallel to the first orthogonal axis; The start and end of any bar chart correspond to the start date and end date of the R & D milestone stage respectively.
7. An electronic device, comprising a memory, a processor, and a computer program stored on the memory and executable on the processor, wherein When the processor executes the program, it implements the steps of the drug R & D competition data analysis method described in any one of claims 1-5.
8. A non-transitory computer-readable storage medium, characterized in that, A computer program is stored thereon, characterized in that when the computer program is executed by a processor, it implements the steps of the drug R & D competition data analysis method described in any one of claims 1-5.
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