Method, device, storage medium and equipment for business allocation of clinical trial projects
Through a scientific allocation method based on project label data and business executive organization location and capability data, the problem of lack of scientificity in business executive organization allocation in clinical trials is solved, and project efficiency and scientificity are improved.
Patent Information
- Application Number
- CN202111438824.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2021-11-29
- Publication Date
- 2025-03-14
- Estimated Expiration
- 2041-11-29
AI Technical Summary
In clinical trials, CRO lacks scientific basis when allocating business executive agencies, which has affected project efficiency.
Business executives are scientifically selected and assigned by scientifically based on project label data of clinical trial projects and location and capability data of candidate business executives.
It improves the completion efficiency of clinical trial projects, ensures the scientificity and replicability of the allocation process, and reduces work costs.
Smart Images

Figure CN114121192B_ABST
Abstract
Description
Technical Field
[0001] The present application relates to the technical field of clinical trial research, and in particular to a method, device, storage medium and equipment for allocating business to a clinical trial project. Background Art
[0002] Contract Research Organization (CRO) mainly provides outsourcing services such as clinical trial planning, clinical trial monitoring, data management, case report form design and consulting. Its target business is mainly concentrated in pharmaceutical companies' medical statistics and clinical trials for pharmacology. Its most notable features are high efficiency and high degree of specialization.
[0003] When conducting clinical trials, CRO generates an outsourcing plan based on the business to be bid, and then assigns the outsourcing plan to the corresponding business execution agency for execution. When assigning business execution agencies, most of them make choices based on personal experience. The selection process lacks scientific basis, which in turn affects the efficiency of project completion. Summary of the invention
[0004] In order to solve the above technical problems, the present application is proposed. The embodiments of the present application provide a method, device, storage medium and equipment for allocating business of a clinical trial project.
[0005] In a first aspect, an embodiment of the present application provides a method for allocating business for a clinical trial project, the method comprising: determining project label data of the clinical trial project based on the trial project business to be allocated of the clinical trial project; determining N selected business execution agencies based on the project label data and M candidate business execution agencies; and allocating the trial project business to be allocated based on the N selected business execution agencies.
[0006] In combination with the first aspect, in certain implementation methods of the first aspect, the project label data includes project indication data, and based on the project label data and M candidate business execution agencies, N selected business execution agencies are determined, including: based on the project indication data, determining the distribution location data of patients matching the trial project business to be assigned; determining the agency location data corresponding to each of the M candidate business execution agencies; and selecting N selected business execution agencies from the M candidate business execution agencies based on the patient distribution location data and the agency location data corresponding to each of the M candidate business execution agencies.
[0007] In combination with the first aspect, in certain implementation methods of the first aspect, based on the patient distribution location data and the agency location data corresponding to each of the M candidate business execution agencies, N selected business execution agencies are selected from the M candidate business execution agencies, including: based on the patient distribution location data and the agency location data corresponding to each of the M candidate business execution agencies, P candidate business execution agencies are selected from the M candidate business execution agencies, where P is a positive integer less than or equal to M and greater than or equal to N; based on the business capability data corresponding to each of the P candidate business execution agencies and the CRO cooperation intention data, N selected business execution agencies are selected from the P candidate business execution agencies.
[0008] In combination with the first aspect, in certain implementation methods of the first aspect, based on the business capability data and CRO cooperation intention data corresponding to each of the P candidate business execution agencies, N selected business execution agencies are selected from the P candidate business execution agencies, including: determining the level information corresponding to each of the P candidate business execution agencies based on the business capability data corresponding to each of the P candidate business execution agencies; determining the historical sedimentation data corresponding to each of the P candidate business execution agencies, and the historical sedimentation data of the CRO corresponding to the clinical trial project; selecting N selected business execution agencies from the P candidate business execution agencies based on the level information, historical sedimentation data and CRO cooperation intention data corresponding to each of the P candidate business execution agencies, and the historical sedimentation data of the CRO corresponding to the clinical trial project.
[0009] In combination with the first aspect, in certain implementations of the first aspect, the business capability data corresponding to the candidate business execution agency includes scale data and / or business acceptance capability data of the business execution agency, and the historical accumulation data corresponding to the candidate business execution agency includes business experience data of the same type as the clinical trial project.
[0010] In combination with the first aspect, in certain implementation methods of the first aspect, based on the patient distribution location data and the agency location data corresponding to each of the M candidate business execution agencies, P candidate business execution agencies are selected from the M candidate business execution agencies, including: based on the patient distribution location data and the agency location data corresponding to each of the M candidate business execution agencies, for the M candidate business execution agencies, P candidate business execution agencies are selected based on the candidate business execution agencies whose patient density in their areas is greater than a preset patient density threshold.
[0011] In combination with the first aspect, in certain implementations of the first aspect, before determining N selected business execution agencies based on the project label data and M candidate business execution agencies, it also includes: determining S countries to which the business of the trial project to be assigned needs to be assigned; for the S countries, determining M candidate business execution agencies that match the clinical trial project based on the project label data.
[0012] In the second aspect, an embodiment of the present application provides a business allocation device for a clinical trial project, the device comprising: a first determination module, used to determine the project label data of the clinical trial project according to the trial project business to be allocated of the clinical trial project; a second determination module, used to determine N selected business execution agencies based on the project label data and M candidate business execution agencies; an allocation module, used to allocate the trial project business to be allocated based on the N selected business execution agencies.
[0013] In a third aspect, an embodiment of the present application provides a computer-readable storage medium, which stores a computer program for executing the business allocation method for a clinical trial project mentioned in any of the above embodiments.
[0014] In a fourth aspect, an embodiment of the present application provides an electronic device, comprising: a processor; a memory for storing instructions executable by the processor; and the processor is used to execute the business allocation method for the clinical trial project mentioned in any of the above embodiments.
[0015] The business allocation method for clinical trial projects provided in the embodiment of the present application obtains the project label data of the clinical trial project through the trial project business to be allocated, determines N selected business execution agencies through the project label data and M candidate business execution agencies, and allocates the project business based on the N selected business execution agencies. Different from allocating clinical trial project business based on personal experience, the present application allocates clinical trial project business from the dimensions of clinical trial projects and business execution agencies. The allocation plan can be completed online, has certain data support, is more scientific, and further improves the efficiency of project completion. BRIEF DESCRIPTION OF THE DRAWINGS
[0016] By describing the embodiments of the present application in more detail in conjunction with the accompanying drawings, the above and other purposes, features and advantages of the present application will become more apparent. The accompanying drawings are used to provide a further understanding of the embodiments of the present application and constitute a part of the specification. Together with the embodiments of the present application, they are used to explain the present application and do not constitute a limitation of the present application. In the accompanying drawings, the same reference numerals generally represent the same components or steps.
[0017] Figure 1 Shown is a flow chart of a business allocation method for a clinical trial project provided by an exemplary embodiment of the present application.
[0018] Figure 2 The figure shows a flow chart of determining N selected business execution agencies based on project tag data and M candidate business execution agencies provided by an exemplary embodiment of the present application.
[0019] Figure 3The figure is a schematic diagram of a process of selecting N selected business execution agencies from M candidate business execution agencies provided by an exemplary embodiment of the present application.
[0020] Figure 4 The figure is a schematic diagram of a flow chart of selecting N selected business execution agencies from P candidate business execution agencies provided by an exemplary embodiment of the present application.
[0021] Figure 5 Shown is a flow chart of a business allocation method for a clinical trial project provided by another exemplary embodiment of the present application.
[0022] Figure 6 Shown is a schematic diagram of the structure of a business allocation device for a clinical trial project provided by an exemplary embodiment of the present application.
[0023] Figure 7 Shown is a schematic structural diagram of an electronic device provided by an exemplary embodiment of the present application. DETAILED DESCRIPTION
[0024] The following will be combined with the drawings in the embodiments of the present application to clearly and completely describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.
[0025] After the CRO generates the business content according to the project it wants to bid, it needs to assign the business content to different business execution agencies to complete. Depending on the business content, the business execution agency contains multiple levels, which are expanded in the following order: country-business execution agency-subject, that is, a certain business content will be assigned to different subjects of multiple business execution agencies in multiple countries. In related technologies, when CRO assigns business content to business execution agencies, it generally selects based on personal experience, and has high requirements for the experience of the staff. The allocation process lacks scientificity, which in turn affects the efficiency of subsequent project completion.
[0026] Figure 1 The figure shows a flow chart of a business allocation method for a clinical trial project provided by an exemplary embodiment of the present application. For example, the execution subject of the business allocation method for a clinical trial project provided by the embodiment of the present application is a server or computer including a CRO system database.
[0027] like Figure 1 As shown, the business allocation method of the clinical trial project includes the following steps.
[0028] Step 10: Determine the project label data of the clinical trial project according to the trial project business to be allocated of the clinical trial project.
[0029] Specifically, the scope of clinical trial projects includes project management, clinical research, data analysis, biostatistics, etc. In clinical trial research, CRO determines the project label data of the clinical trial project based on the trial project business to be assigned to the clinical trial project.
[0030] The project label data includes data such as the type of project, the indication of the project, the project is divided into X phases to be completed, and the number of subjects required.
[0031] Step 40: Determine N selected business execution agencies based on the project tag data and the M candidate business execution agencies.
[0032] Specifically, based on the project label data of the clinical trial project business to be assigned and M candidate business execution agencies that match the project label data, N selected business execution agencies are selected from the M candidate business execution agencies.
[0033] Wherein, M and N are both positive integers, and N is less than or equal to M, for example, M=300, N=20; M=17, N=17.
[0034] Step 50: Allocate the trial project business to be allocated based on the N selected business execution agencies.
[0035] As an example, for a clinical trial project research on burn drugs, the CRO will formulate a trial project business plan for the research, and based on the data information of the N selected business execution agencies in the CRO system database, allocate corresponding trial project businesses to the N selected business execution agencies, including the phased plan of the business and the number of subjects.
[0036] As an example, if the value of N is 4, that is, 4 selected business execution agencies are finally determined to complete the clinical trial project business of burn drugs, and the clinical trial project business requires a total of 1,000 subjects. Based on the data information of the 4 selected business execution agencies in the CRO system database, the CRO allocates 400, 300, 200, and 100 subjects to each selected business execution agency in turn.
[0037] The business allocation method for clinical trial projects provided in the embodiment of the present application obtains the project label data of the clinical trial project through the trial project business to be allocated, determines N selected business execution agencies through the project label data and M candidate business execution agencies, and allocates the trial project business based on the N selected business execution agencies. Different from allocating trial project business based on personal experience, the present application allocates trial project business from the dimensions of clinical trial projects and business execution agencies. The allocation plan can be completed online, has certain data support, is more scientific, and further improves the completion efficiency of clinical trial projects.
[0038] Figure 2 A flowchart of determining N selected business execution agencies based on project tag data and M candidate business execution agencies is provided as an exemplary embodiment of the present application. Figure 1 The present application is extended based on the embodiment shown Figure 2 The embodiment shown is described below in detail. Figure 2 The embodiment shown and Figure 1 The differences and similarities of the illustrated embodiments are not described in detail.
[0039] like Figure 2 As shown, in the business allocation method of the clinical trial project provided in the embodiment of the present application, the project label data includes project indication data. Based on the project label data and M candidate business execution agencies, the step of determining N selected business execution agencies includes the following steps.
[0040] Step 41, based on the project indication data, determine the distribution location data of patients matching the business of the trial project to be assigned.
[0041] As an example, if a CRO wants to conduct a clinical trial project on a heart disease drug, the indication data for the project is heart disease. After analyzing the CRO system database, it is found that patients with heart disease are mainly concentrated in the eastern United States. Therefore, based on objective statistical data analysis, the distribution location data of patients who match the business of the trial project to be assigned is determined to be the location data of the eastern United States.
[0042] As another example, if a CRO wants to conduct a clinical trial project on malaria drugs, the indication data of the project is malaria. After analyzing the database of the CRO system, patients with malaria are mainly concentrated in western Vietnam. Based on this statistical result, the distribution location data of patients matching the business of the trial project to be assigned is determined to be the location data of western Vietnam.
[0043] Step 42: Determine the agency location data corresponding to each of the M candidate business execution agencies.
[0044] Specifically, using the example in step 41, if the CRO wants to conduct a clinical trial project on cardiac drugs, the CRO will retrieve all M candidate business execution agencies in the eastern United States that can conduct clinical trials on cardiac drugs from its system database, and determine the specific agency location data corresponding to each of the M candidate business execution agencies. If the CRO wants to conduct a clinical trial on malaria drugs, the CRO will retrieve all M candidate business execution agencies in the western part of Vietnam that can conduct clinical trials on malaria drugs from its system database, and determine the specific agency location data corresponding to each of the M candidate business execution agencies.
[0045] Step 43 : Based on the patient distribution location data and the agency location data corresponding to each of the M candidate service execution agencies, N selected service execution agencies are selected from the M candidate service execution agencies.
[0046] Continuing with the example in step 42, if a clinical trial project on cardiac drugs is to be conducted, the CRO will further analyze the main concentrated areas of heart disease patients in its system database. The analysis result shows that heart disease patients are mainly concentrated in area A in the eastern United States. Based on the agency location data corresponding to each of the M candidate business execution agencies, the CRO will ultimately select N selected business execution agencies in area A from the M candidate business execution agencies in its system. If a clinical trial on malaria drugs is to be conducted, the CRO will further analyze the main concentrated areas of malaria patients in its system database. The analysis result shows that malaria patients are mainly concentrated in area B in western Vietnam. Based on the agency location data corresponding to each of the M candidate business execution agencies, the CRO will ultimately select N selected business execution agencies in area B from the M candidate business execution agencies in its system.
[0047] Furthermore, the CRO transfers the data information of the finally determined N selected actuators into a database.
[0048] The business allocation method for clinical trial projects provided in the embodiment of the present application first determines the countries and regions where patients matching the indication data are mainly distributed based on the indication data of the project, determines M candidate business execution agencies in the country and region based on the countries and regions where the patients are mainly distributed, and further analyzes the more detailed distribution areas of the patients in the country and region through the CRO system database, and selects N selected business execution agencies from the M candidate business execution agencies based on the analysis results. The process of determining the N selected business execution agencies is supported by statistical data, and the selection method of the N selected business execution agencies is more scientific and replicable, does not require the staff to have very rich work experience, and further reduces the work cost of the CRO.
[0049] Figure 3The figure shows a flow chart of selecting N selected service execution agencies from M candidate service execution agencies provided by an exemplary embodiment of the present application. Figure 2 The present application is extended based on the embodiment shown Figure 3 The embodiment shown is described below in detail. Figure 3 The embodiment shown and Figure 2 The differences and similarities of the illustrated embodiments are not described in detail.
[0050] like Figure 3 As shown, in the business allocation method for a clinical trial project provided in an embodiment of the present application, based on the patient distribution location data and the agency location data corresponding to each of the M candidate business execution agencies, the step of selecting N selected business execution agencies from the M candidate business execution agencies includes the following steps.
[0051] Step 431: Based on the patient distribution location data and the agency location data corresponding to the M candidate service execution agencies, P candidate service execution agencies are selected from the M candidate service execution agencies. P is a positive integer less than or equal to M and greater than or equal to N.
[0052] Specifically, following the example in step 43, based on the statistical results of the CRO system database, heart disease patients are mainly concentrated in region A in the eastern United States. The CRO will exclude candidate business execution agencies that are not in region A from the M candidate business execution agencies and select P business execution agencies in region A. Malaria patients are mainly concentrated in region B in western Vietnam. The CRO will exclude candidate business execution agencies that are not in region B from the M candidate business execution agencies and select P business execution agencies in region B.
[0053] Step 432: Select N selected business execution agencies from the P candidate business execution agencies based on the business capability data and CRO cooperation intention data corresponding to each of the P candidate business execution agencies.
[0054] Specifically, the CRO cooperation intention data refers to the past cooperation intention data with CROs of P candidate business execution agencies in the CRO system database. The business capability data and CRO cooperation intention data corresponding to each of the P candidate business execution agencies are retrieved from the CRO system database, and after comprehensive evaluation of these data, N selected business execution agencies are selected from the P candidate business execution agencies.
[0055] The business allocation method for clinical trial projects provided in the embodiment of the present application selects P candidate business execution agencies from the M candidate business execution agencies based on the location information of further concentrated areas of patients and the location information of M candidate business execution agencies, and then selects N selected business execution agencies based on the business capability data of the P candidate business execution agencies and the CRO cooperation intention data in the CRO database, and further refines the method for determining the N selected business execution agencies through some data information to facilitate execution by staff.
[0056] Figure 4 The flowchart of selecting N selected service execution agencies from P candidate service execution agencies provided by an exemplary embodiment of the present application is as follows. Figure 3 The present application is extended based on the embodiment shown Figure 4 The embodiment shown is described below in detail. Figure 4 The embodiment shown and Figure 3 The differences and similarities of the illustrated embodiments are not described in detail.
[0057] like Figure 4 As shown, in the business allocation method for clinical trial projects provided in an embodiment of the present application, based on the business capability data and CRO cooperation intention data corresponding to each of the P candidate business execution agencies, the step of selecting N selected business execution agencies from the P candidate business execution agencies includes the following steps.
[0058] Step 4321: Determine the level information corresponding to each of the P candidate business execution agencies based on the business capability data corresponding to each of the P candidate business execution agencies.
[0059] Specifically, the business capability data corresponding to the candidate business execution organization includes scale data and / or business undertaking capability data of the business execution organization.
[0060] As an example, according to the scale data and / or business acceptance capacity data of P candidate business institutions in the CRO system database, the P candidate business institutions are divided into four levels: A, B, C, and D. The scale and business acceptance capacity of the business execution institutions at the four levels A, B, C, and D decrease in sequence. The level information corresponding to each of the P candidate business execution institutions is marked in the CRO system database.
[0061] Step 4322, determine the historical accumulation data corresponding to each of the P candidate business execution agencies, and the historical accumulation data of the CRO corresponding to the clinical trial project.
[0062] Specifically, the historical accumulation data corresponding to the candidate business execution agencies include business experience data of the same type as the clinical trial project. The historical accumulation data of the CRO refers to the historical cooperation data between the CRO and P candidate business execution agencies.
[0063] As an example, historical cooperation data between P candidate business execution agencies and CROs are retrieved from the database of the CRO system. If the candidate business execution agency has no past cooperation with the CRO, "none" is recorded in the CRO database. If the candidate business execution agency has cooperated with the CRO, the cooperation information between the two is retrieved, such as the project field of cooperation, the business completion degree of the candidate business execution agency, the project result information of cooperation, etc.
[0064] Step 4323, based on the level information, historical accumulation data and CRO cooperation intention data corresponding to each of the P candidate business execution agencies, as well as the historical accumulation data of the CRO corresponding to the clinical trial project, select the N selected business execution agencies from the P candidate business execution agencies.
[0065] Specifically, when selecting N selected business execution agencies from P candidate business execution agencies, priority is given to business execution agencies with high levels, experience in clinical trials in the same field, strong intention to cooperate with CROs, and previous clinical trial cooperation with CROs in the field. The number N of selected business execution agencies is greater than the number of business execution agencies required for the clinical trial project, so that business execution agencies can be replaced at any time in case of unexpected situations during the trial.
[0066] On the premise that the P candidate business execution agencies are mainly concentrated in the geographical areas of patients matching the indications of the clinical trial project, the P candidate business execution agencies are further evaluated for comprehensive conditions based on their information in the CRO system database to determine the N selected business execution agencies. The determination process of the N selected business execution agencies is based on objective historical data and the cooperation intentions of the candidate business execution agencies and CROs, eliminating the influence of subjective factors of staff, making the determination process more scientific and the determination results more accurate, further promoting the smooth progress of clinical trial projects.
[0067] In an exemplary embodiment, based on patient distribution location data and the agency location data corresponding to each of the M candidate business execution agencies, P candidate business execution agencies are selected from the M candidate business execution agencies, including: based on the patient distribution location data and the agency location data corresponding to each of the M candidate business execution agencies, for the M candidate business execution agencies, the P candidate business execution agencies are selected based on the candidate business execution agencies whose patient density in their areas is greater than a preset patient density threshold.
[0068] Using the example in step 42, for the M candidate business execution agencies in the eastern region of the United States, the preset heart disease patient density threshold is 100. If the patient density in the region where the candidate business execution agency is located is less than 100, the candidate business execution agency is excluded. In this way, P candidate business execution agencies with a patient density greater than 100 are screened out from the M candidate business execution agencies. The patient density threshold is selected based on the number of subjects required for the clinical trial project business.
[0069] P candidate business execution agencies are selected based on the patient density threshold. This method is simple, convenient and highly operational. The patient density threshold can be reasonably set according to different clinical trial project businesses, thereby achieving the purpose of selecting P candidate business execution agencies from a large number of M candidate business execution agencies.
[0070] Figure 5 FIG. 1 is a flow chart of a method for allocating business of a clinical trial project provided by another exemplary embodiment of the present application. Figure 1 The present application is extended based on the embodiment shown Figure 5 The embodiment shown is described below in detail. Figure 5 The embodiment shown and Figure 1 The differences and similarities of the illustrated embodiments are not described in detail.
[0071] like Figure 5 As shown, in the business allocation method for clinical trial projects provided in the embodiment of the present application, before determining N selected business execution agencies based on project label data and M candidate business execution agencies, the method also includes the following steps.
[0072] Step 20, determining S countries to which the pilot project services to be allocated need to be allocated.
[0073] Specifically, before assigning a trial project business, the country to which the trial project business needs to be assigned must first be determined. As an example, a trial project business to be assigned by a CRO needs to be tested in two countries, China and the United States.
[0074] Step 30, for S countries, determine M candidate business execution agencies that match the clinical trial project based on the project label data.
[0075] Specifically, for each of the S countries, M candidate business execution agencies matching the clinical trial project in each country are determined based on the project label data.
[0076] As an example, a clinical trial project business to be assigned by a CRO requires a total of 1,000 subjects for clinical trials, which need to be carried out in China and the United States, of which China needs to conduct clinical trials on 400 subjects and the United States needs to conduct clinical trials on 600 subjects. China and the United States then determine M candidate business execution organizations that match the clinical trial project business based on the project label data to complete the clinical trials of the required number of subjects.
[0077] The candidate business execution agencies and selected business execution agencies mentioned in the above embodiments are both business execution agencies. The candidate business execution agencies are all business execution agencies that meet the requirements of being located in the main patient distribution areas. The selected business execution agencies are business execution agencies that, in addition to meeting the aforementioned requirement of being located in the main patient distribution areas, also meet the subjective requirements of the CRO.
[0078] Combination of the above Figures 1 to 5 , describes in detail the embodiment of the business allocation method of the clinical trial project of the present application, and the following is combined with Figure 6 , describes in detail the embodiment of the business allocation device for clinical trial projects of the present application. It should be understood that the description of the embodiment of the business allocation method for clinical trial projects corresponds to the description of the embodiment of the business allocation device for clinical trial projects, and therefore, the parts not described in detail can refer to the previous method embodiment.
[0079] Figure 6 The figure shows a schematic diagram of the structure of a business allocation device for a clinical trial project provided by an exemplary embodiment of the present application. Figure 6 As shown, the business allocation device for clinical trial projects provided in the embodiment of the present application includes:
[0080] A first determination module 100 is used to determine the project label data of the clinical trial project according to the to-be-allocated trial project business of the clinical trial project;
[0081] A second determination module 200 is used to determine N selected business execution agencies based on the project tag data and the M candidate business execution agencies;
[0082] The allocation module 300 is used to allocate the trial project business to be allocated based on N selected business execution agencies.
[0083] In one embodiment of the present application, the second determination module 200 is also used to determine the distribution location data of patients matching the trial project business to be assigned based on the project indication data; determine the agency location data corresponding to each of M candidate business execution agencies; and select N selected business execution agencies from the M candidate business execution agencies based on the patient distribution location data and the agency location data corresponding to each of the M candidate business execution agencies.
[0084] In one embodiment of the present application, the second determination module 200 is also used to select P candidate business execution agencies from M candidate business execution agencies based on the patient distribution location data and the agency location data corresponding to each of the M candidate business execution agencies, where P is a positive integer less than or equal to M and greater than or equal to N; and select N selected business execution agencies from the P candidate business execution agencies based on the business capability data and CRO cooperation intention data corresponding to each of the P candidate business execution agencies.
[0085] In one embodiment of the present application, the second determination module 200 is also used to determine the level information corresponding to each of the P candidate business execution agencies based on the business capability data corresponding to each of the P candidate business execution agencies; determine the historical sedimentation data corresponding to each of the P candidate business execution agencies, and the historical sedimentation data of the CRO corresponding to the clinical trial project; based on the level information, historical sedimentation data and CRO cooperation intention data corresponding to each of the P candidate business execution agencies, and the historical sedimentation data of the CRO corresponding to the clinical trial project, select the N selected business execution agencies from the P candidate business execution agencies. The business capability data corresponding to the candidate business execution agency includes the scale data and / or business acceptance capability data of the business execution agency, and the historical sedimentation data corresponding to the candidate business execution agency includes the business experience data of the same type as the clinical trial project.
[0086] In one embodiment of the present application, the second determination module 200 is also used to select P candidate business execution agencies from the M candidate business execution agencies based on the patient distribution location data and the agency location data corresponding to each of the M candidate business execution agencies, based on the candidate business execution agencies whose patient density in their areas is greater than a preset patient density threshold.
[0087] In one embodiment of the present application, the second determination module 200 is also used to determine S countries to which the trial project business needs to be allocated; for the S countries, determine M candidate business execution agencies that match the clinical trial project based on the project label data.
[0088] Below, reference Figure 7 To describe an electronic device according to an embodiment of the present application. Figure 7 Shown is a schematic structural diagram of an electronic device provided by an exemplary embodiment of the present application.
[0089] like Figure 7 As shown, the electronic device 70 includes one or more processors 701 and a memory 702 .
[0090] The processor 701 may be a central processing unit (CPU) or other forms of processing units having data processing capabilities and / or instruction execution capabilities, and may control other components in the electronic device 70 to perform desired functions.
[0091] The memory 702 may include one or more computer program products, and the computer program product may include various forms of computer-readable storage media, such as volatile memory and / or non-volatile memory. The volatile memory may include, for example, random access memory (RAM) and / or cache memory (cache), etc. The non-volatile memory may include, for example, read-only memory (ROM), hard disk, flash memory, etc. One or more computer program instructions may be stored on the computer-readable storage medium, and the processor 701 may run the program instructions to implement the business allocation method of the clinical trial project of each embodiment of the present application described above and / or other desired functions. Various contents such as business capability data corresponding to each candidate business execution agency, historical precipitation data, and historical precipitation data of the CRO corresponding to the clinical trial project may also be stored in the computer-readable storage medium.
[0092] In one example, the electronic device 70 may further include: an input device 703 and an output device 704, and these components are interconnected via a bus system and / or other forms of connection mechanisms (not shown).
[0093] The input device 703 may include, for example, a keyboard, a mouse, etc.
[0094] The output device 704 can output various information to the outside, including the scale data corresponding to the business execution agency, the business acceptance capacity data, the historical precipitation data corresponding to the candidate business execution agency, etc. The output device 704 can include, for example, a display, a speaker, a printer, a communication network and its connected remote output device, etc.
[0095] Of course, to simplify, Figure 7 Only some of the components related to the present application in the electronic device 70 are shown, and components such as a bus, an input / output interface, etc. are omitted. In addition, according to specific application conditions, the electronic device 70 may also include any other appropriate components.
[0096] In addition to the above-mentioned methods and devices, an embodiment of the present application may also be a computer program product, which includes computer program instructions, which, when executed by a processor, enable the processor to execute the steps of the business allocation method for clinical trial projects according to various embodiments of the present application described above in this specification.
[0097] The computer program product may be written in any combination of one or more programming languages to write program codes for performing the operations of the embodiments of the present application, including object-oriented programming languages, such as Java, C++, etc., and conventional procedural programming languages, such as "C" language or similar programming languages. The program code may be executed entirely on the user computing device, partially on the user device, as an independent software package, partially on the user computing device and partially on a remote computing device, or entirely on a remote computing device or server.
[0098] In addition, an embodiment of the present application may also be a computer-readable storage medium on which computer program instructions are stored. When the computer program instructions are executed by a processor, the processor executes the steps of the business allocation method for clinical trial projects according to various embodiments of the present application described above in this specification.
[0099] The computer readable storage medium can adopt any combination of one or more readable media. The readable medium can be a readable signal medium or a readable storage medium. The readable storage medium can include, for example, but is not limited to, a system, device or device of electricity, magnetism, light, electromagnetic, infrared, or semiconductor, or any combination of the above. More specific examples (non-exhaustive list) of readable storage media include: an electrical connection with one or more wires, a portable disk, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or flash memory), an optical fiber, a portable compact disk read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the above.
[0100] The basic principles of the present application are described above in conjunction with specific embodiments. However, it should be noted that the advantages, strengths, effects, etc. mentioned in the present application are only examples and not limitations, and it cannot be considered that these advantages, strengths, effects, etc. are required by each embodiment of the present application. In addition, the specific details disclosed above are only for the purpose of illustration and ease of understanding, not for limitation, and the above details do not limit the present application to being implemented by adopting the above specific details.
[0101] The block diagrams of the devices, apparatuses, equipment, and systems involved in this application are only illustrative examples and are not intended to require or imply that they must be connected, arranged, and configured in the manner shown in the block diagram. As will be appreciated by those skilled in the art, these devices, apparatuses, equipment, and systems can be connected, arranged, and configured in any manner. Words such as "including", "comprising", "having", etc. are open words, referring to "including but not limited to", and can be used interchangeably with them. The words "or" and "and" used here refer to the words "and / or" and can be used interchangeably with them, unless the context clearly indicates otherwise. The words "such as" used here refer to the phrase "such as but not limited to", and can be used interchangeably with them.
[0102] It should also be noted that in the apparatus, device and method of the present application, each component or each step can be decomposed and / or recombined. Such decomposition and / or recombination should be regarded as equivalent solutions of the present application.
[0103] The above description of the disclosed aspects is provided to enable any person skilled in the art to make or use the present application. Various modifications to these aspects will be readily apparent to those skilled in the art, and the general principles defined herein may be applied to other aspects without departing from the scope of the present application. Therefore, the present application is not intended to be limited to the aspects shown herein, but rather to the widest scope consistent with the principles and novel features disclosed herein.
[0104] The above description has been given for the purpose of illustration and description. In addition, this description is not intended to limit the embodiments of the present application to the forms disclosed herein. Although multiple example aspects and embodiments have been discussed above, those skilled in the art will recognize certain variations, modifications, changes, additions and sub-combinations thereof.
Claims
1. A method for allocating business of a clinical trial project, characterized in that: include: Determine the project label data of the clinical trial project according to the trial project business to be allocated for the clinical trial project; Determine N selected business execution agencies based on the project tag data and the M candidate business execution agencies; Allocate the trial project business to be allocated based on the N selected business execution agencies; The project label data includes project indication data, and the determining of N selected business execution agencies based on the project label data and M candidate business execution agencies includes: Based on the project indication data, determine the distribution location data of patients matching the business of the trial project to be assigned; Determine the agency location data corresponding to each of the M candidate business execution agencies; Based on the patient distribution location data and the agency location data corresponding to each of the M candidate service execution agencies, select P candidate service execution agencies from the M candidate service execution agencies, where P is a positive integer less than or equal to M and greater than or equal to N; Determine the level information corresponding to each of the P candidate business execution agencies based on the business capability data corresponding to each of the P candidate business execution agencies; Determine the historical sedimentation data corresponding to each of the P candidate business execution agencies, and the historical sedimentation data of the CRO corresponding to the clinical trial project; Selecting the N selected business execution agencies from the P candidate business execution agencies based on the level information, historical accumulation data and CRO cooperation intention data corresponding to each of the P candidate business execution agencies, and the historical accumulation data of the CRO corresponding to the clinical trial project; Among them, the business capability data corresponding to the candidate business execution agency includes the scale data and / or business acceptance capability data of the business execution agency, and the historical accumulation data corresponding to the candidate business execution agency includes business experience data of the same type as the clinical trial project.
2. The business allocation method for clinical trial projects according to claim 1, characterized in that: Based on the patient distribution location data and the agency location data corresponding to each of the M candidate service execution agencies, P candidate service execution agencies are selected from the M candidate service execution agencies, including: Based on the patient distribution location data and the agency location data corresponding to the M candidate business execution agencies, the P candidate business execution agencies are selected from the M candidate business execution agencies based on the candidate business execution agencies whose areas are located with a patient density greater than a preset patient density threshold.
3. The business allocation method for clinical trial projects according to claim 1 or 2, characterized in that: Before determining N selected business execution agencies based on the project tag data and the M candidate business execution agencies, the method further includes: Determine the S countries to which the pilot project services to be allocated need to be allocated; For the S countries, the M candidate business execution agencies matching the clinical trial project are determined based on the project label data.
4. A business allocation device for a clinical trial project, characterized in that: include: A first determination module is used to determine the project label data of the clinical trial project according to the to-be-allocated trial project business of the clinical trial project; A second determination module is used to determine N selected business execution agencies based on the project tag data and the M candidate business execution agencies; An allocation module, configured to allocate the trial item business to be allocated based on the N selected business execution agencies; The project label data includes project indication data, and the second determination module is further used to determine, based on the project indication data, the distribution location data of patients matching the to-be-assigned trial project business; determine the agency location data corresponding to each of the M candidate business execution agencies; based on the patient distribution location data and the agency location data corresponding to each of the M candidate business execution agencies, select P candidate business execution agencies from the M candidate business execution agencies, where P is a positive integer less than or equal to M and greater than or equal to N; based on the business capability data corresponding to each of the P candidate business execution agencies, determine the level information corresponding to each of the P candidate business execution agencies; Determine the historical accumulated data corresponding to each of the P candidate business execution agencies, and the historical accumulated data of the CRO corresponding to the clinical trial project; select the N selected business execution agencies from the P candidate business execution agencies based on the level information, historical accumulated data and CRO cooperation intention data corresponding to each of the P candidate business execution agencies, and the historical accumulated data of the CRO corresponding to the clinical trial project; wherein the business capability data corresponding to the candidate business execution agencies include scale data and / or business acceptance capability data of the business execution agencies, and the historical accumulated data corresponding to the candidate business execution agencies include business experience data of the same type as the clinical trial project.
5. A computer-readable storage medium, characterized in that: The storage medium stores a computer program, and the computer program is used to execute the business allocation method for clinical trial projects according to any one of claims 1 to 3 above.
6. An electronic device, characterized in that: The electronic device comprises: processor; a memory for storing instructions executable by the processor; The processor is used to execute the business allocation method for clinical trial projects as described in any one of claims 1 to 3 above.
Citation Information
Patent Citations
Clinical research center screening method and device
CN112416939A