Drug curative effect evaluation method, system, equipment and medium

Abstract

The invention relates to the technical field of medical data processing, and discloses a drug curative effect evaluation method, system, equipment and medium. Based on drug group clinical test data and placebo group clinical test data of a to-be-evaluated drug, an accurate drug curative effect index is calculated for the to-be-evaluated drug; and quantitative drug curative effect evaluation of the to-be-evaluated drug is realized. According to the method, the drug curative effect index is calculated, the drug curative effect is converted into a quantifiable index, and the objectivity and the accuracy of an evaluation result are remarkably improved. Through comprehensive analysis of clinical test data of a drug group and a placebo group, cross-disease and cross-population drug curative effect evaluation can be realized, for example, not only can the curative effect of the drug in a single disease be evaluated, but also the curative effect evaluation of different disease systems can be expanded, so that more comprehensive drug curative effect data can be provided. The invention provides a systematic and precise new tool for evaluating the curative effect of the medicine, and has important clinical application and research and development values.

Description

Technical Field

[0001] The present invention relates to the technical field of medical data processing, and particularly to a method, system, device and medium for evaluating drug efficacy. Background Art

[0002] As the main means of treating human diseases, the pharmaceutical industry has made remarkable progress since the early 20th century. Currently, more than 5,000 drugs have been approved globally, and more than 6,000 are in clinical trials. The rapid progress of drug development has significantly increased its share in the medical market, and the pharmaceutical field accounts for about 20% of the global medical expenditure. However, despite the important role of drugs in the medical system, their overall clinical efficacy has not been clearly quantified, and there are many limitations in existing drug efficacy evaluation methods. For example, existing research mostly focuses on specific disease areas, such as cardiovascular diseases, cancers or metabolic diseases, etc., lacking a systematic evaluation of the overall efficacy of drugs. This one-sided evaluation method makes it impossible to comprehensively reflect the efficacy differences of drugs in different diseases or populations, and it is difficult to provide comprehensive efficacy data across diseases and populations. Also, current drug efficacy evaluations mostly rely on qualitative or semi-quantitative methods, such as subjective evaluations by clinicians, self-reports by patients or analyses based on limited biomarkers. These methods are difficult to provide precise quantitative data, resulting in great subjectivity and uncertainty in the evaluation results of drug efficacy.

[0003] Therefore, there is an urgent need for a new method for evaluating drug efficacy. Summary of the Invention

[0004] The present invention provides a method, system, device and medium for evaluating drug efficacy, aiming to solve the defects that existing drug efficacy evaluation methods are mostly limited to specific disease areas, lacking a systematic evaluation of the overall efficacy of drugs, and mainly relying on qualitative or semi-quantitative means, making it difficult to provide precise quantitative data, resulting in one-sidedness and subjectivity in the evaluation results.

[0005] A method for evaluating drug efficacy provided by the present invention includes:

[0006] Obtaining the clinical trial data of the drug group and the clinical trial data of the placebo group of the drug to be evaluated;

[0007] According to the clinical trial data of the drug group and the clinical trial data of the placebo group under the treatment conditions of the corresponding indication of the drug to be evaluated, through the drug efficacy evaluation expression, obtaining the drug efficacy index of the drug to be evaluated;

[0008] According to the obtained drug efficacy index of the drug to be evaluated, obtaining the drug efficacy evaluation result of the drug to be evaluated.

[0009] A method for evaluating the efficacy of a drug provided by the present invention, wherein the clinical trial data of the drug group includes the outcome value, the ineffective value, and the target value of the population in the drug group, and the clinical trial data of the placebo group includes the outcome value, the ineffective value, and the target value of the population in the placebo group.

[0010] Among them, the outcome value refers to the measured value of the outcome index of the population in the drug group and the placebo group under the actual treatment conditions of each indication corresponding to the drug to be evaluated, which is the average observed value of the corresponding outcome index of the population in the drug group or the placebo group at the end of the clinical trial, including continuous values (such as scale scores, laboratory indicators, etc.) and binary variable values (such as the number of deaths, the number of people meeting the standard, etc.). The ineffective value refers to the measured value of the outcome index if the treatment of the indication is ineffective. In continuous variables, the ineffective value indicates that the disease has not improved at all, for example, the scale score or laboratory indicator has not changed, and it usually equals the baseline value of the patient before drug treatment. In binary variables, the ineffective value indicates that all events have occurred or all have not occurred: for positive indicators (such as reaching the standard event), the ineffective value is 0; for negative indicators (such as death events), the ineffective value is the total number of the population. The target value refers to the measured value of the outcome index when the indication is completely recovered, representing the state where the patient reaches a completely healthy state or the disease is completely cured after receiving treatment. In continuous variables, the target value indicates that the measurement endpoint reaches the normal level of the healthy population; in binary variables, the target value indicates that all events have occurred or all have not occurred, which is opposite to the ineffective value. According to a method for evaluating the efficacy of a drug provided by the present invention, the drug efficacy evaluation expression is:

[0011]

[0012] According to a method for evaluating the efficacy of a drug provided by the present invention, obtaining the drug efficacy index of the drug to be evaluated and obtaining the drug efficacy evaluation result of the drug to be evaluated includes:

[0013] According to the drug efficacy index of the drug to be evaluated, obtaining the drug efficacy evaluation result of the drug to be evaluated, wherein the value range of the drug efficacy index is [0, 1]. When the drug efficacy index is 0, it indicates that the drug has no therapeutic effect. When the drug efficacy index is 1, it indicates that the drug has achieved the treatment target.

[0014] The present invention also provides a method for evaluating the overall drug efficacy of prescription drugs, including:

[0015] Obtaining a set of prescription drugs to be evaluated;

[0016] Obtaining the clinical trial data of the drug group and the clinical trial data of the placebo group of each prescription drug to be evaluated in the set of prescription drugs to be evaluated under the treatment conditions of their respective corresponding indications;

[0017] According to the clinical trial data of the drug group and the placebo group of each prescription drug to be evaluated under the treatment conditions of their respective corresponding indications in the set of prescription drugs to be evaluated, using the drug efficacy evaluation method described in any one of the above, the drug efficacy index of each prescription drug to be evaluated in the set of prescription drugs to be evaluated is obtained;

[0018] According to the drug efficacy index of each prescription drug to be evaluated in the set of prescription drugs to be evaluated, the overall drug efficacy evaluation result of the set of prescription drugs to be evaluated is obtained.

[0019] In one embodiment, the set of prescription drugs to be evaluated can be obtained through user input or from a database, preferably from a database. The database can be a publicly available public medical database on the Internet (for example, the Medical Expenditure Panel Survey Database MEPS), a public health management agency at the national or administrative division level, a public or internal medical information database of a medical consortium hospital or a certain hospital, a medical information database of a certain department of a hospital, or a dedicated medical information database for statistics of specific system diseases or indications. Information and usage of prescription drugs are recorded in this database, including but not limited to, drug name (drug active name and / or trade name), annual or monthly prescription volume, number of purchasers, and drug expenditure situation. The method for obtaining the set of prescription drugs to be evaluated can be specifically selected according to needs, such as selecting a specific drug set, or selecting according to the prescription volume ranking (for example, sorting from high to low), or selecting according to the number of purchasers (i.e., usage frequency), or it can also be selected according to the expenditure ranking (for example, sorting from high to low).

[0020] According to a method for overall drug efficacy evaluation of prescription drugs provided by the present invention, the obtaining of the overall drug efficacy evaluation result of the set of prescription drugs to be evaluated according to the drug efficacy index of each prescription drug to be evaluated in the set of prescription drugs to be evaluated includes:

[0021] Calculating the average value of the drug efficacy index of each prescription drug to be evaluated in the set of prescription drugs to be evaluated as the drug efficacy index of the set of prescription drugs to be evaluated;

[0022] According to the drug efficacy index of the set of prescription drugs to be evaluated, the overall drug efficacy evaluation result of the set of prescription drugs to be evaluated is obtained.

[0023] In one embodiment, the method for overall drug efficacy evaluation of prescription drugs further includes the step of evaluating the overall drug efficacy level of the set of prescription drugs to be evaluated. If the drug efficacy index (DEI) is less than 0.5, the actual treatment efficacy level of the set of prescription drugs to be evaluated is low; if the DEI is less than 0.75 and greater than or equal to 0.5, the actual treatment efficacy level of the set of prescription drugs to be evaluated is high; if the DEI is less than or equal to 1.0 and greater than or equal to 0.75, the actual treatment efficacy level of the set of prescription drugs to be evaluated is very high, approaching the ideal efficacy.

[0024] In the public health management system of a country or region, the distribution of the overall drug efficacy index of prescription drugs can provide a scientific basis for drug management, selection, and clinical medication. When the DEI is lower than 0.5, it indicates that the actual therapeutic efficacy of this type of drug is relatively low, and strict reviews should be carried out in aspects such as medical insurance access and essential drug selection to avoid limited medical resources being occupied by low-efficacy drugs. Clinically, higher-efficacy alternative drugs should be considered first. If the DEI is between 0.5 and 0.75, it shows that the drug efficacy is relatively high, and it can be used as a supplementary treatment plan for the second line or specific populations, and moderately recommended in the guidelines. At the same time, further real-world studies are encouraged. For drugs with a DEI between 0.75 and 1.0, their efficacy is close to the ideal state, and they can be preferentially included in the national essential drug list or the medical insurance reimbursement scope, and recommended as the first choice in the guidelines to improve patient accessibility. The application of the drug efficacy index helps to optimize the allocation of medical resources, ensure the balance between drug economy and efficacy, and at the same time, in the health economic evaluation, combined with cost-benefit analysis, it provides a more accurate decision-making basis for rational drug use.

[0025] The present invention also provides a method for evaluating the drug efficacy of prescription drugs for a disease system, including:

[0026] Obtaining a set of prescription drugs to be evaluated;

[0027] Dividing the prescription drugs to be evaluated in the set of prescription drugs to be evaluated into prescription drugs to be evaluated for different disease systems;

[0028] Obtaining the clinical trial data of the drug group and the clinical trial data of the placebo group of each prescription drug to be evaluated in the set of prescription drugs to be evaluated under the treatment conditions of their respective corresponding disease systems;

[0029] According to the clinical trial data of the drug group and the clinical trial data of the placebo group of each prescription drug to be evaluated in the set of prescription drugs to be evaluated under the treatment conditions of their respective corresponding disease systems, using the drug efficacy evaluation method described in any one of the above, obtain the drug efficacy index of each prescription drug to be evaluated in the set of prescription drugs to be evaluated;

[0030] According to the drug efficacy index of each prescription drug to be evaluated corresponding to different disease systems, obtain the drug efficacy evaluation results of the prescription drugs corresponding to each disease system.

[0031] According to a drug efficacy evaluation method provided by the present invention, the obtaining of the drug efficacy evaluation results of the diseases corresponding to different disease systems according to the drug efficacy index of the prescription drugs to be evaluated for different disease systems includes:

[0032] For each disease system, calculate the average value of the drug efficacy index of the prescription drugs to be evaluated corresponding to it as the drug efficacy index of the disease corresponding to this disease system;

[0033] Based on the drug efficacy indexes of diseases corresponding to different disease systems, the drug efficacy evaluation results of diseases corresponding to different disease systems are obtained.

[0034] According to a drug efficacy evaluation method provided by the present invention, obtaining the drug efficacy evaluation results of prescription drugs corresponding to each disease system according to the drug efficacy indexes of each prescription drug to be evaluated corresponding to different disease systems includes:

[0035] For each disease system, calculate the average value of the drug efficacy indexes of all prescription drugs to be evaluated corresponding thereto as the drug efficacy index of the prescription drugs corresponding to this disease system;

[0036] Based on the drug efficacy indexes of prescription drugs corresponding to different disease systems, the drug efficacy evaluation results of prescription drugs corresponding to different disease systems are obtained.

[0037] In one embodiment, the disease systems are classified according to the first-level anatomical classification in the Anatomical Therapeutic Chemical (ATC) drug classification system formulated by the World Health Organization. The set of prescription drugs to be evaluated is divided into prescription drugs for different disease systems according to these disease systems.

[0038] In one embodiment, the drug efficacy evaluation method for prescription drugs of the disease system further includes the step of evaluating the drug efficacy level of the set of prescription drugs to be evaluated for the corresponding disease system. If, for a certain disease system, the drug efficacy index (DEI) of the set of prescription drugs to be evaluated is less than 0.5, the actual treatment efficacy level of this set of prescription drugs to be evaluated is low; if the DEI is less than 0.75 and greater than or equal to 0.5, the actual treatment efficacy level of this set of prescription drugs to be evaluated is high; if the DEI is less than or equal to 1.0 and greater than or equal to 0.75, the actual treatment efficacy level of this set of prescription drugs to be evaluated is very high and close to the ideal efficacy.

[0039] Using the distribution of the drug efficacy indexes of drugs for different disease systems, more reasonable decision-making on the allocation of disciplinary resources can be made within limited resources, and the development of disciplinary scientific research and clinical practice can be guided. Taking neurological diseases as an example, although there are many commonly used drugs and they are widely used, the overall DEI of the prescription drug set is low, with an average of only 0.25, far lower than that of the cardiovascular, digestive and metabolic systems. This indicates that the existing treatment regimens for neurological diseases still lack efficient interventions targeting the causes. Therefore, basic research still needs to be strengthened, the development of innovative drugs and new treatment technologies should be promoted, and at the same time, clinical trial strategies should be optimized to improve the overall treatment level of neurological diseases.

[0040] The present invention also provides a drug efficacy evaluation method for prescription drugs for indications, and this method includes:

[0041] Obtain a set of prescription drugs to be evaluated for an indication;

[0042] Obtain the clinical trial data of the drug group and the clinical trial data of the placebo group for each prescription drug to be evaluated in the set of prescription drugs to be evaluated under the treatment conditions of the indication;

[0043] According to the clinical trial data of the drug group and the clinical trial data of the placebo group for each prescription drug to be evaluated in the set of prescription drugs to be evaluated, use the drug efficacy evaluation method described in any one of the above to obtain the drug efficacy index of each prescription drug to be evaluated in the set of prescription drugs to be evaluated;

[0044] According to the drug efficacy index of the prescription drug to be evaluated, obtain the drug efficacy evaluation result of each prescription drug to be evaluated for the indication.

[0045] In one embodiment, the drug efficacy evaluation method for the prescription drug for the indication further includes the step of evaluating the drug efficacy level of each prescription drug to be evaluated for the indication. If the DEI is less than 0.5, the actual treatment efficacy level of the prescription to be evaluated is relatively low; if the DEI is less than 0.75 and greater than or equal to 0.5, the actual treatment efficacy level of the prescription to be evaluated is relatively high; if the DEI is less than or equal to 1.0 and greater than or equal to 0.75, the actual treatment efficacy level of the prescription to be evaluated is very high and close to the ideal efficacy.

[0046] Using the distribution of the drug efficacy index of drugs for the same indication can provide a scientific basis for drug prescription writing, clinical outpatient and ward medication guidance. When the DEI < 0.5, outpatient prescriptions should be cautious, and ward medications should only be considered when there are no better options; when 0.5 ≤ DEI < 0.75, the efficacy is relatively high, suitable for outpatient and inpatient patients; when 0.75 ≤ DEI ≤ 1.0, the efficacy is close to the ideal, recommended as the preferred plan and widely used in outpatient clinics and wards. This system helps to optimize clinical decisions, improve the level of rational drug use, and enhance patient benefits.

[0047] The present invention also provides a drug efficacy evaluation method for a prescription drug for an indication, including:

[0048] Obtain a set of prescription drugs to be evaluated for an indication;

[0049] Obtain the clinical trial data of the drug group and the clinical trial data of the placebo group for each prescription drug to be evaluated in the set of prescription drugs to be evaluated under the treatment conditions of the indication;

[0050] According to the clinical trial data of the drug group and the clinical trial data of the placebo group for each prescription drug to be evaluated in the set of prescription drugs to be evaluated, use the drug efficacy evaluation method described in any one of the above to obtain the drug efficacy index of each prescription drug to be evaluated in the set of prescription drugs to be evaluated;

[0051] Based on the drug efficacy index of the prescription drug to be evaluated, the drug efficacy evaluation result of each prescription drug to be evaluated for the indication is obtained.

[0052] The present invention also provides a drug efficacy evaluation system, including:

[0053] A data acquisition module, configured to: acquire the clinical trial data of the drug group and the clinical trial data of the placebo group of the drug to be evaluated;

[0054] A calculation module, configured to: obtain the drug efficacy index of the drug to be evaluated through a drug efficacy evaluation expression according to the clinical trial data of the drug group and the clinical trial data of the placebo group of the drug to be evaluated;

[0055] An evaluation module, configured to: obtain the drug efficacy evaluation result of the drug to be evaluated according to the obtained drug efficacy index of the drug to be evaluated.

[0056] The present invention also provides an electronic device, including a processor and a memory storing a computer program, and when the processor executes the computer program, any one or any combination of the above-mentioned drug efficacy evaluation method, overall drug efficacy evaluation method for prescription drugs, drug efficacy evaluation method for prescription drugs in a disease system, and drug efficacy evaluation method for prescription drugs for an indication is implemented.

[0057] The present invention also provides a non-transitory computer-readable storage medium, on which a computer program is stored, and when the computer program is executed by a processor, any one or any combination of the above-mentioned drug efficacy evaluation method, overall drug efficacy evaluation method for prescription drugs, drug efficacy evaluation method for prescription drugs in a disease system, and drug efficacy evaluation method for prescription drugs for an indication is implemented.

[0058] The present invention also provides a computer program product, the computer program product includes a computer program, the computer program can be stored on a non-transitory computer-readable storage medium, and when the computer program is executed by a processor, the computer can execute any one or any combination of the above-mentioned drug efficacy evaluation method, overall drug efficacy evaluation method for prescription drugs, drug efficacy evaluation method for prescription drugs in a disease system, and drug efficacy evaluation method for prescription drugs for an indication.

[0059] A method, system, device and medium for evaluating drug efficacy provided by the present invention calculate an accurate drug efficacy index for a drug to be evaluated based on the clinical trial data of the drug group and the placebo group of the drug to be evaluated, so as to realize the quantitative drug efficacy evaluation of the drug to be evaluated. By calculating the drug efficacy index, the present invention converts drug efficacy into a quantifiable index, significantly improving the objectivity and accuracy of the evaluation results. For example, the drug efficacy index can intuitively reflect the degree of efficacy improvement of the drug relative to the placebo, providing a scientific basis for clinical decision-making, R & D optimization and regulatory policy formulation. By comprehensively analyzing the clinical trial data of the drug group and the placebo group, the present invention can realize the drug efficacy evaluation across diseases and populations. For example, it can not only evaluate the efficacy of a drug in a single disease, but also extend to the efficacy evaluation of different disease systems (such as the cardiovascular system, the nervous system, etc.), thus providing more comprehensive drug efficacy data. The present invention provides a new systematic and precise tool for drug efficacy evaluation, which has important clinical application and R & D value. BRIEF DESCRIPTION OF THE DRAWINGS

[0060] In order to more clearly illustrate the technical solutions in 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.

[0061] Figure 1 It is a schematic flowchart of a method for evaluating drug efficacy provided by the present invention.

[0062] Figure 2 It is the prescription volume, number of purchasers, drug cost expenditure and disease distribution of the top 100 prescription drugs in terms of prescription volume.

[0063] Figure 3 It is the drug efficacy evaluation result of the top 100 prescription drugs in terms of prescription volume.

[0064] Figure 4 It is the drug efficacy evaluation result of prescription drugs for different disease systems and indications.

[0065] Figure 5 It is a schematic structural diagram of a drug efficacy evaluation system provided by the present invention.

[0066] Figure 6 It is a schematic structural diagram of an electronic device provided by the present invention. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0067] To make the objectives, technical solutions, and advantages of the present invention clearer, the technical solutions in the present invention will be clearly and completely described below in conjunction with the accompanying drawings in the present invention. Obviously, the described embodiments are some, but not all, of the embodiments of the present invention, and they should not be construed as limiting the present invention. All other embodiments obtained by those of ordinary skill in the art based on the embodiments in the present invention without creative efforts fall within the scope of protection of the present invention. In the description of the present invention, it should be understood that the terms used are only for the purpose of description and cannot be construed as indicating or implying relative importance.

[0068] Figure 1 It is a schematic flowchart of a method for evaluating the efficacy of a drug provided by the present invention. The execution subject of the method for evaluating the efficacy of a drug provided by the present invention can be any applicable terminal-side device or network-side device, such as a drug efficacy evaluation device, etc.

[0069] See Figure 1 , a method for evaluating the efficacy of a drug provided by the present invention may include:

[0070] S110. Obtain the clinical trial data of the drug group and the placebo group of the drug to be evaluated under the treatment conditions of the corresponding indication.

[0071] In one embodiment, the clinical trial data of the drug group includes the outcome value, invalid value, and target value of the drug group population, and the clinical trial data of the placebo group includes the outcome value, invalid value, and target value of the placebo group population. Among them, the outcome value refers to the measured value of the outcome index of the drug group population and the placebo group population under the actual treatment conditions of each indication corresponding to the drug to be evaluated, and is the within-group average observed value of the corresponding outcome index of the drug group or the placebo group population at the end of the clinical trial. The invalid value refers to the measured value of the outcome index indicating ineffective treatment of the indication. In continuous variables, the invalid value indicates that the disease has not improved at all and is usually equal to the baseline value of the patient before drug treatment. In binary variables, the invalid value indicates that all events have occurred or all have not occurred: for positive indicators (such as reaching the standard event), the invalid value is 0; for negative indicators (such as death events), the invalid value is the total number of people in the population. The target value refers to the measured value of the outcome index indicating complete recovery of the indication, representing the state where the patient reaches a completely healthy state or the disease is completely cured after receiving treatment.

[0072] In one embodiment, for each disease, outcome indicators that can best reflect the disease state and drug efficacy are selected. The selection basis of these indicators comes from the authoritative guidelines and expert opinions related to each disease, ensuring the scientificity and applicability of the indicators. This embodiment provides the indications and outcome indicators corresponding to the top 100 drugs as shown in the following table.

[0073]

[0074]

[0075]

[0076]

[0077] S120. Based on the clinical trial data of the drug group and the placebo group of the drug to be evaluated under the treatment conditions of the corresponding indication, through the drug efficacy evaluation expression, obtain the drug efficacy index of the drug to be evaluated.

[0078] The drug efficacy evaluation expression is:

[0079]

[0080] S130. Based on the obtained drug efficacy index of the drug to be evaluated, obtain the drug efficacy evaluation result of the drug to be evaluated. Among them, the value range of the drug efficacy index is [0, 1]. When the drug efficacy index is 0, it means that the drug has no therapeutic effect. When the drug efficacy index is 1, it means that the drug has achieved the treatment goal.

[0081] In one embodiment, a drug list of prescription drugs can be established first. From the prescription drug file of the Household Components in the Medical Expenditure Panel Survey (MEPS) database, extract the drug names of prescription drugs. The drug names of prescription drugs in MEPS are the names of drug active ingredients. Use the surveyR package to adjust the weights at the individual level and estimate the annual prescription volume, the number of purchasers, and the drug cost expenditure of all prescription drugs. Construct a drug list of prescription drugs based on the drug names, prescription volume, the number of purchasers, and drug expenditure information.

[0082] Then collect and standardize the indications of prescription drugs, and retrieve the latest version of the prescribing information file of prescription drugs in the Drugs@FDA database. Extract the indications of each drug from the "Indications and Usag" section. For prescription drugs lacking prescribing information in the Drugs@FDA database, supplement them with the DailyMed database. Manually retrieve the keywords of the indications in the prescribing information using the OpenTargets database, and standardize the indications of prescription drugs using the disease terms in the Mondo Disease Ontology and the Experimental Factor Ontology (EFO).

[0083] Collect the key clinical trial data of the indications of prescription drugs. Specifically, for each standardized indication, according to clinical guidelines and expert recommendations, and considering the universality of the indication, select the clinical endpoint indicators and target values of the indication. The target value represents the measured value of the outcome indicator for disease recovery. By systematically searching the PubMed database, using the drug active ingredient, indication, and endpoint indicator of the prescription drug as keywords, relevant literature is screened. Two reviewers independently screen out randomized controlled trials (RCTs) evaluated as high-quality based on factors such as sample size, placebo control, endpoint consistency, and rigor of study design. For disagreements during the screening process, consensus is reached through consultation or consulting clinical experts. For each selected RCT, two reviewers independently extract the relevant data for calculating the Drug Efficacy Index (DEI), including the invalid values and outcome values of the drug group and the placebo group. The invalid value refers to the measured value of the outcome indicator for ineffective disease treatment, and the outcome value refers to the outcome indicator of the disease under actual treatment conditions. If a suitable endpoint indicator cannot be obtained in high-quality RCTs, the secondary endpoint is selected as a substitute according to the trial quality and expert opinions. When an active control drug is used in the selected RCT, placebo-controlled RCTs of the control drug are screened according to the same criteria, and the corresponding placebo effect is calculated to correct the drug efficacy results.

[0084] Then, using the drug efficacy evaluation expression, calculate the drug efficacy index of each drug to be evaluated according to the clinical trial data of the drug group and the placebo group of the drug to be evaluated. Then calculate the overall drug efficacy and the drug efficacy of different diseases. The average value of the DEI of all prescription drugs can be calculated, which is the overall drug efficacy of prescription drugs. According to the first-level anatomical classification in the Anatomical Therapeutic Chemical (ATC) drug classification system formulated by the World Health Organization, prescription drugs are classified into drugs for different disease systems. Calculate the average DEI of prescription drugs in different disease systems respectively, which is the drug efficacy of different diseases.

[0085] The following describes a drug efficacy evaluation method provided by the present invention through Example 1.

[0086] Example 1: Evaluation of the overall drug efficacy of the top 100 prescription drugs in terms of prescription volume

[0087] Example 1 evaluates the overall efficacy of prescription drugs according to the drug efficacy evaluation system and standardized process provided by the present invention. In this example, the top 100 prescription drugs in terms of prescription volume are selected as representative examples (the set of prescription drugs to be evaluated) to evaluate the overall drug efficacy and the drug efficacy of different diseases.

[0088] Step 1: Establish a drug list of prescription drugs;

[0089] Extract the drug names of prescription drugs from the latest 2022 Household Components prescription drug files in the Medical Expenditure Panel Survey (MEPS) database. The drug names of prescription drugs in MEPS are the names of drug active ingredients. Use the survey R package to adjust the weights at the individual level and estimate the annual prescription volume, number of purchasers, and drug expenditures of all prescription drugs. According to the prescription volume ranking, screen out the top 100 prescription drugs in terms of prescription volume, and construct a drug list of prescription drugs with information on the drug names, prescription volume, number of purchasers, and drug expenditures of these drugs. Calculate the cumulative proportions of the prescription volume, number of purchasers, and drug expenditures of the top 100 prescription drugs in the overall drugs.

[0090] Step 2: Collect and standardize the indications of prescription drugs;

[0091] Retrieve the latest version of the prescribing information files of prescription drugs in the Drugs@FDA database. Extract the indications of each drug from the "Indications and Usage" section. For prescription drugs lacking prescribing information in the Drugs@FDA database, supplement them using the DailyMed database. Manually retrieve the keywords of the indications in the prescribing information using the Open Targets database, and standardize the indications of prescription drugs using the disease terms in the Mondo Disease Ontology and the Experimental Factor Ontology (EFO). Classify prescription drugs into drugs for different disease systems according to the first-level anatomical classification in the Anatomical Therapeutic Chemical (ATC) drug classification system established by the World Health Organization. Statistically calculate the quantity and proportion of the top 100 prescription drugs in different indications and disease systems.

[0092] Step 3: Collect key clinical trial data for the indications of prescription drugs;

[0093] For each standardized indication, based on clinical guidelines and expert recommendations, and considering the universality of the indication, the clinical endpoint indicators and target values of the indication were selected. The target value represents the measured value of the outcome indicator for disease recovery. By systematically searching the PubMed database, using the drug active ingredient, indication, and endpoint indicator of prescription drugs as keywords, relevant literature was screened. Two reviewers independently selected randomized controlled trials (RCTs) that were evaluated as high-quality based on factors such as sample size, placebo control, endpoint consistency, and study design rigor. For disagreements during the screening process, consensus was reached through consultation or by consulting clinical experts. For each selected RCT, two reviewers independently extracted the relevant data for calculating the Drug Efficacy Index (DEI), including the invalid values and outcome values of the drug group and the placebo group. The invalid value refers to the measured value of the outcome indicator for ineffective disease treatment, and the outcome value refers to the outcome indicator of the disease under actual treatment conditions. If a suitable endpoint indicator could not be obtained from high-quality RCTs, secondary endpoints were selected as alternatives based on the trial quality and expert opinions. When an active control drug was used in the selected RCTs, placebo-controlled RCTs of the control drug were screened according to the same criteria, and the corresponding placebo effect was calculated to correct the drug efficacy results.

[0094] Step 4: Calculate the Drug Efficacy Index for each prescription drug using clinical trial data;

[0095] Substitute the trial data collected in Step 3 into the calculation formula of DEI to calculate the DEI of each prescription drug.

[0096] Step 5: Evaluate the overall drug efficacy and the drug efficacy for different diseases;

[0097] Calculate the average value of the DEIs of all prescription drugs in Step 4, which is the overall drug efficacy of prescription drugs. Then calculate the average DEI of prescription drugs in different disease systems respectively, which is the drug efficacy for different diseases.

[0098] To analyze the overall effects of approved drugs, in this embodiment, the top 100 drugs in terms of U.S. prescription volume were selected as representative drugs. The analysis results show that these 100 drugs account for 78.81% of the total prescription volume, 73.53% of the number of patients purchasing drugs, and 67.64% of the total drug expenditure ( Figure 2 a - c). These drugs cover 11 disease systems and 44 indications. The proportions of drugs in each disease system are as Figure 2 shown in Figure 2As shown in e, among which hypertension, severe depression and diabetes rank top three. These results indicate that the top 100 prescription drugs in terms of prescription volume, as a representative sample of approved drugs, cover a wide range of therapeutic areas and have high representativeness.

[0099] Taking the Drug Efficacy Index (DEI) as the evaluation index of drug efficacy, in this embodiment, the efficacy of the top 100 prescription drugs in terms of prescription volume is evaluated respectively. The results show that the average DEI of these drugs is 0.3208, indicating that the average efficacy of the top 100 prescription drugs is 32.08% ( Figure 3 a). The DEI of the top 100 prescription drugs is as Figure 3 shown in b, among which rosuvastatin has the highest DEI, followed by glipizide and ethinyl estradiol / norethindrone combination preparation. To more intuitively display the distribution of different efficacy levels, in this embodiment, the DEI of the top 100 prescription drugs is divided into four quartile intervals, and the proportion of drugs within each interval is shown in Figure 3 c. The results show that only 7% of the drugs have a DEI between 0.75 and 1.0; 14% of the drugs have a DEI between 0.5 and 0.75; 28% of the drugs have a DEI between 0.25 and 0.5. While most drugs (51%) have a DEI below 0.25 ( Figure 3 c). In summary, these results indicate that the overall efficacy of drugs is still limited, highlighting the significant gap between the actual treatment effect and the ideal efficacy.

[0100] Based on the Anatomical Therapeutic Chemical (ATC) code and the main indications of the top 100 prescription drugs in terms of prescription volume, in this embodiment, the average drug efficacy index (DEI) of different disease systems and indications is calculated. The results show that the top three disease systems with the highest average DEI are the digestive and metabolic system (0.47±0.25), the cardiovascular system (0.46±0.25) and the respiratory system (0.34±0.24). The average DEI of the blood and hematopoietic organ system is the lowest, only 0.05±0.03. Only four disease systems have an average drug efficacy higher than the overall average level ( Figure 4 a). From the perspective of drug indications, the average DEI of contraceptive drugs is the highest (0.83), while the average DEI of drugs for coronary artery disease is the lowest (0.01). It is worth noting that the drug efficacy range of cardiovascular indications is relatively wide, ranging from 0.06 to 0.67 ( Figure 4 b). These results reveal the significant differences in drug efficacy between different disease systems and indications.

[0101] A method, system, device and medium for evaluating the efficacy of a drug provided by the present invention calculate an accurate drug efficacy index for the drug to be evaluated based on the clinical trial data of the drug group and the placebo group of the drug to be evaluated, and realize the quantitative evaluation of the drug efficacy of the drug to be evaluated.

[0102] By calculating the drug efficacy index, the present invention converts the drug efficacy into a quantifiable index, significantly improving the objectivity and accuracy of the evaluation results. For example, the drug efficacy index can intuitively reflect the degree of improvement in the efficacy of the drug relative to the placebo, providing a scientific basis for clinical decision-making, R & D optimization and regulatory policy formulation.

[0103] By comprehensively analyzing the clinical trial data of the drug group and the placebo group, the present invention can realize the evaluation of the drug efficacy across diseases and populations. For example, it can not only evaluate the efficacy of the drug in a single disease, but also extend to the evaluation of the efficacy in different disease systems (such as the cardiovascular system, the nervous system, etc.), thereby providing more comprehensive drug efficacy data.

[0104] The present invention can also provide a method for evaluating the overall drug efficacy of prescription drugs, including:

[0105] Obtain a set of prescription drugs to be evaluated;

[0106] Obtain the clinical trial data of the drug group and the placebo group of each prescription drug to be evaluated under the treatment conditions of their respective corresponding indications;

[0107] According to the clinical trial data of the drug group and the placebo group of each prescription drug to be evaluated under the treatment conditions of their respective corresponding indications, use the above drug efficacy evaluation method to obtain the drug efficacy index of each prescription drug to be evaluated in the set of prescription drugs to be evaluated;

[0108] According to the drug efficacy index of each prescription drug to be evaluated in the set of prescription drugs to be evaluated, obtain the overall drug efficacy evaluation result of the set of prescription drugs to be evaluated. Specifically, the average value of the drug efficacy indexes of each prescription drug to be evaluated in the set of prescription drugs to be evaluated can be calculated as the drug efficacy index of the set of prescription drugs to be evaluated; according to the drug efficacy index of the set of prescription drugs to be evaluated, obtain the overall drug efficacy evaluation result of the set of prescription drugs to be evaluated.

[0109] The present invention can also provide a method for evaluating the drug efficacy of prescription drugs for a disease system, including:

[0110] Obtain a set of prescription drugs to be evaluated;

[0111] Divide the prescription drugs to be evaluated in the set of prescription drugs to be evaluated into prescription drugs to be evaluated for different disease systems;

[0112] Obtain the clinical trial data of the drug group and the clinical trial data of the placebo group for each prescription drug to be evaluated under the treatment conditions of their respective corresponding disease systems;

[0113] According to the clinical trial data of the drug group and the clinical trial data of the placebo group for each prescription drug to be evaluated under the treatment conditions of their respective corresponding disease systems, use the drug efficacy evaluation method described above to obtain the drug efficacy index of each prescription drug to be evaluated in the set of prescription drugs to be evaluated;

[0114] According to the drug efficacy indexes of each prescription drug to be evaluated corresponding to different disease systems, obtain the drug efficacy evaluation results of the prescription drugs corresponding to each disease system. Specifically, for each disease system, calculate the average value of the drug efficacy indexes of all prescription drugs to be evaluated corresponding to it as the drug efficacy index of the prescription drugs corresponding to this disease system; according to the drug efficacy indexes of the prescription drugs corresponding to different disease systems, obtain the drug efficacy evaluation results of the prescription drugs corresponding to different disease systems.

[0115] The present invention can also provide a drug efficacy evaluation method for indication prescription drugs, including:

[0116] Obtain a set of prescription drugs to be evaluated for one indication;

[0117] Obtain the clinical trial data of the drug group and the clinical trial data of the placebo group for each prescription drug to be evaluated under the treatment conditions of the indication;

[0118] According to the clinical trial data of the drug group and the clinical trial data of the placebo group for each prescription drug to be evaluated in the set of prescription drugs to be evaluated, use the drug efficacy evaluation method described above to obtain the drug efficacy index of each prescription drug to be evaluated in the set of prescription drugs to be evaluated;

[0119] According to the drug efficacy index of the prescription drug to be evaluated, obtain the drug efficacy evaluation result of each prescription drug to be evaluated for the indication.

[0120] The drug efficacy evaluation system provided by the present invention will be described below. The drug efficacy evaluation system described below can be mutually corresponding and referred to the drug efficacy evaluation method described above.

[0121] See Figure 5 , a drug efficacy evaluation system provided by the present invention may include:

[0122] A data acquisition module, configured to: obtain the clinical trial data of the drug group and the clinical trial data of the placebo group of the drug to be evaluated;

[0123] A calculation module, configured to: obtain a drug efficacy index of a drug to be evaluated through a drug efficacy evaluation expression according to clinical trial data of a drug group and clinical trial data of a placebo group of the drug to be evaluated under the treatment conditions of the corresponding indication.

[0124] An evaluation module, configured to: obtain a drug efficacy evaluation result of the drug to be evaluated according to the obtained drug efficacy index of the drug to be evaluated.

[0125] 6 exemplifies a schematic physical structure diagram of an electronic device, as Figure 6 shown, the electronic device may include: a processor 810, a communication interface 820, a memory 830, and a communication bus 840. Among them, the processor 810, the communication interface 820, and the memory 830 complete mutual communication through the communication bus 840. The processor 810 may call logic instructions in the memory 830 to execute any one or any combination of the above-mentioned drug efficacy evaluation method, the overall drug efficacy evaluation method for prescription drugs, the drug efficacy evaluation method for prescription drugs of a disease system, and the drug efficacy evaluation method for prescription drugs of an indication.

[0126] In addition, when the logic instructions in the above-mentioned memory 830 are implemented in the form of software function units and sold or used as an independent product, they may 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, may 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 various embodiments of the present invention. The foregoing storage medium includes: various media such as a USB flash drive, a mobile hard disk, a read-only memory (ROM, Read-Only Memory), a random access memory (RAM, Random Access Memory), a magnetic disk, or an optical disc that can store program codes.

[0127] On the other hand, the present invention also provides a computer program product. The computer program product includes a computer program. The computer program can be stored on a non-transitory computer-readable storage medium. When the computer program is executed by a processor, the computer can execute any one or any combination of the above-mentioned drug efficacy evaluation method, the overall drug efficacy evaluation method for prescription drugs, the drug efficacy evaluation method for prescription drugs of a disease system, and the drug efficacy evaluation method for prescription drugs of an indication.

[0128] In another aspect, the present invention also 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 any one or any combination of the above-mentioned drug efficacy evaluation method, prescription drug overall drug efficacy evaluation method, prescription drug efficacy evaluation method for a disease system, and prescription drug efficacy evaluation method for an indication.

[0129] 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 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. A person of ordinary skill in the art can understand and implement it without creative effort.

[0130] 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 essence of the above technical solution, 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.

[0131] 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 perform equivalent replacements for some of the technical features. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A method for evaluating drug efficacy, characterized in that, Including: Obtaining the clinical trial data of the drug group and the placebo group of the drug to be evaluated; According to the clinical trial data of the drug group and the placebo group of the drug to be evaluated under the treatment conditions of the corresponding indication, through the drug efficacy evaluation expression, obtaining the drug efficacy index of the drug to be evaluated; According to the obtained drug efficacy index of the drug to be evaluated, obtaining the drug efficacy evaluation result of the drug to be evaluated.

2. The method for evaluating drug efficacy according to claim 1, wherein The clinical trial data of the drug group includes the outcome value, ineffective value, and target value of the drug group population, and the clinical trial data of the placebo group includes the outcome value, ineffective value, and target value of the placebo group population. Among them, the outcome value refers to the measured value of the outcome index of the drug group population and the placebo group population under the actual treatment conditions of each indication corresponding to the drug to be evaluated, the ineffective value refers to the measured value of the outcome index when the treatment of the indication is ineffective, and the target value refers to the measured value of the outcome index when the indication recovers.

3. The method for evaluating drug efficacy according to claim 2, characterized in that, The drug efficacy evaluation expression is: And, the obtaining the drug efficacy evaluation result of the drug to be evaluated according to the obtained drug efficacy index of the drug to be evaluated includes: According to the drug efficacy index of the drug to be evaluated, obtaining the drug efficacy evaluation result of the drug to be evaluated, where the value range of the drug efficacy index is [0, 1]. When the drug efficacy index is 0, it means that the drug has no therapeutic effect, and when the drug efficacy index is 1, it means that the drug has achieved the treatment goal.

4. A method for evaluating the overall therapeutic effect of a prescription drug, characterized in that, Including: Obtaining the set of prescription drugs to be evaluated; Obtaining the clinical trial data of the drug group and the placebo group of each prescription drug to be evaluated in the treatment conditions of their respective corresponding indications; According to the clinical trial data of the drug group and the placebo group of each prescription drug to be evaluated in the treatment conditions of their respective corresponding indications, using the drug efficacy evaluation method described in any one of claims 1-3, obtaining the drug efficacy index of each prescription drug to be evaluated in the set of prescription drugs to be evaluated; According to the drug efficacy index of each prescription drug to be evaluated in the set of prescription drugs to be evaluated, obtaining the overall drug efficacy evaluation result of the set of prescription drugs to be evaluated.

5. The overall drug efficacy evaluation method for prescription drugs according to claim 4, characterized in that, The obtaining the overall drug efficacy evaluation result of the set of prescription drugs to be evaluated according to the drug efficacy index of each prescription drug to be evaluated in the set of prescription drugs to be evaluated includes: Calculating the average value of the drug efficacy index of each prescription drug to be evaluated in the set of prescription drugs to be evaluated as the drug efficacy index of the set of prescription drugs to be evaluated; According to the drug efficacy index of the set of prescription drugs to be evaluated, obtaining the overall drug efficacy evaluation result of the set of prescription drugs to be evaluated.

6. A method for evaluating the therapeutic efficacy of a prescription drug for a disease system, characterized in that, Including: Obtaining the set of prescription drugs to be evaluated; Dividing the prescription drugs to be evaluated in the set of prescription drugs to be evaluated into prescription drugs to be evaluated for different disease systems; Obtaining the clinical trial data of the drug group and the placebo group of each prescription drug to be evaluated in the treatment conditions of their respective corresponding disease systems; Based on the clinical trial data of the drug group and the placebo group for each prescription drug to be evaluated under the treatment conditions of their respective corresponding disease systems in the set of prescription drugs to be evaluated, using the drug efficacy evaluation method described in any one of claims 1-3, obtain the drug efficacy index of each prescription drug to be evaluated in the set of prescription drugs to be evaluated; Based on the drug efficacy indices of each prescription drug to be evaluated corresponding to different disease systems, obtain the drug efficacy evaluation results of the prescription drugs corresponding to each disease system.

7. The method for evaluating the drug efficacy of the prescription drug in the system according to claim 6, characterized in that The obtaining of the drug efficacy evaluation results of the prescription drugs corresponding to each disease system based on the drug efficacy indices of each prescription drug to be evaluated corresponding to different disease systems includes: For each disease system, calculate the average value of the drug efficacy indices of all the prescription drugs to be evaluated corresponding to it as the drug efficacy index of the prescription drugs corresponding to this disease system; Based on the drug efficacy indices of the prescription drugs corresponding to different disease systems, obtain the drug efficacy evaluation results of the prescription drugs corresponding to different disease systems.

8. A method for evaluating the therapeutic efficacy of a prescription drug for an indication, characterized in that, Including: Obtain a set of prescription drugs to be evaluated for an indication; Obtain the clinical trial data of the drug group and the placebo group for each prescription drug to be evaluated in the set of prescription drugs to be evaluated under the treatment conditions of the indication; Based on the clinical trial data of the drug group and the placebo group for each prescription drug to be evaluated in the set of prescription drugs to be evaluated, using the drug efficacy evaluation method described in any one of claims 1-3, obtain the drug efficacy index of each prescription drug to be evaluated in the set of prescription drugs to be evaluated; Based on the drug efficacy index of the prescription drug to be evaluated, obtain the drug efficacy evaluation result of each prescription drug to be evaluated for the indication.

9. An electronic device, comprising a memory, a processor, and a computer program stored on the memory and executable on the processor, characterized in that, When the processor executes the program, it implements any one or any combination of the drug efficacy evaluation method described in any one of claims 1 to 3, the overall drug efficacy evaluation method of prescription drugs described in claim 4 or 5, the drug efficacy evaluation method of prescription drugs for disease systems described in claim 6 or 7, and the drug efficacy evaluation method of prescription drugs for indications described in claim 8.

10. A non-transitory computer-readable storage medium, having a computer program stored thereon, characterized in that, When the computer program is executed by the processor, it implements any one or any combination of the drug efficacy evaluation method described in any one of claims 1 to 3, the overall drug efficacy evaluation method of prescription drugs described in claim 4 or 5, the drug efficacy evaluation method of prescription drugs for disease systems described in claim 6 or 7, and the drug efficacy evaluation method of prescription drugs for indications described in claim 8.

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