A method and system for experimental selection studies

Abstract

This application provides a method and system for trial selection research, belonging to the field of trial selection technology. The method includes: acquiring data on the number of participants and trial time; calculating the impact data on the number of participants based on the number of participants, and calculating the impact data on the trial start time based on the trial time data; acquiring historical trial data, and determining historical comparison data on trial start based on the historical trial data; and outputting trial start necessity data based on the impact data on the number of participants, the impact data on the trial start time, and the historical comparison data on trial start. This approach ensures the timely completion of trials and improves the effectiveness of trials.

Description

Technical Field

[0001] This application relates to the field of test selection technology, and in particular to a test selection research method and system. Background Technology

[0002] Drug clinical trials are typically divided into four phases, each with different objectives, resulting in a lengthy overall trial period. Furthermore, the selection criteria for participants vary across phases. For participants, treatment with the drug and follow-up are essential steps throughout the entire clinical trial process. The selection of participants is crucial, and prior to each phase, a screening process is conducted to identify eligible participants. However, the required number of participants varies in each phase. Starting the clinical trial only after recruiting the required number would lead to a prolonged overall trial period, exceeding the expected timeframe. Therefore, to ensure the efficiency of drug clinical trials, a rolling enrollment approach is often adopted. This involves initially selecting a certain number of participants and recruiting the next batch concurrently. This method ensures both timely completion and high efficiency of the trial. Summary of the Invention

[0003] This application provides a research method and system for trial selection, which can ensure the trial time and efficiency of drug clinical trials.

[0004] Firstly, this application provides a research method for experimental selection. The method includes:

[0005] Acquire subject number data and trial time data; the subject number data includes the number of identified subjects in the current stage of the drug clinical trial, the total number of pre-selected subjects, and the number of subjects remaining in the subject pool to be screened; the trial time data is the remaining time of the current trial period;

[0006] The impact data on the number of subjects initiated is calculated based on the subject count data, and the impact data on the trial start time is calculated based on the trial time data.

[0007] Acquire historical trial data and determine historical comparison data for trial initiation based on the historical trial data; the historical trial data includes the number of subjects required for other trials in the same historical period and the remaining time for other trials in the same historical period;

[0008] Based on the data on the impact of the number of trials initiated, the data on the impact of the trial initiation time, and the historical comparison data of trial initiation, the necessity data for initiating trials is output; the necessity data for initiating trials represents the degree of necessity for starting a drug clinical trial at the current time point.

[0009] Furthermore, the calculation of the impact data on the number of participants initiating the trial based on the participant count data, and the calculation of the impact data on the trial initiation time based on the trial time data, include:

[0010] Calculate the current stage's participant recruitment gap data based on the number of identified participants and the total number of pre-selected participants in the current phase of the drug clinical trial;

[0011] The impact data on subject resources at the current stage are calculated based on the number of identified subjects, the number of subjects remaining in the subject pool to be screened, and the total number of pre-selected subjects at the current stage of the drug clinical trial.

[0012] The impact data on the number of trials initiated were obtained based on the current stage participant recruitment gap data and the current stage participant resource impact data.

[0013] Furthermore, the acquisition of historical trial data and the determination of historical trial initiation comparison data based on the historical trial data; the historical trial data includes the number of subjects required for other trials in the same historical period and the remaining time for other trials in the same historical period, including:

[0014] Calculate the historical average number of subjects required based on the number of subjects required in other trials during the same historical period;

[0015] The median remaining time in history was determined based on the remaining time of other trials in the same historical period.

[0016] Historical comparative data for trial initiation were determined based on the remaining time of the current trial period, the historical average number of participants required, and the median remaining time in history.

[0017] Furthermore, the step of outputting trial initiation necessity data based on the trial initiation quantity impact data, the trial initiation time impact data, and the trial initiation history comparison data; the trial initiation necessity data characterizes the degree of necessity for starting the drug clinical trial at the current time point, including:

[0018]

[0019] E need =TE

[0020] In the formula, TINI represents the necessity data for initiating the experiment; S represents the impact data of the number of experiments initiated. This data represents the current recruitment gap for test takers. This data represents the impact of current participant resources, where E is the number of identified participants, T is the total number of pre-selected participants, and R is the number of remaining participants in the participant pool awaiting screening; L represents historical comparison data from the trial initiation. need To determine the number of subjects still needing to be recruited, H e H represents the historical average number of subjects required. t The median remaining historical time; T left The remaining time of the current test period; K1 and K2 are the preset first quantity weight and preset second quantity weight, respectively.

[0021] Furthermore, K1 + K2 = 1.

[0022] Secondly, this application provides an experimental selection research system. The system includes:

[0023] The acquisition module is used to acquire subject quantity data and trial time data; the subject quantity data includes the number of identified subjects in the current stage of the drug clinical trial, the total number of pre-selected subjects, and the number of subjects remaining in the subject pool to be screened; the trial time data is the remaining time of the current trial period;

[0024] The calculation module is used to calculate the impact data of the number of subjects starting the trial based on the subject number data, and to calculate the impact data of the trial start time based on the trial time data;

[0025] The determination module is used to acquire historical trial data and determine historical comparison data for trial initiation based on the historical trial data; the historical trial data includes the number of subjects required for other trials in the same historical period and the remaining time for other trials in the same historical period;

[0026] The output module is used to output trial initiation necessity data based on the trial initiation quantity impact data, the trial initiation time impact data, and the trial initiation history comparison data; the trial initiation necessity data characterizes the degree of necessity for starting the drug clinical trial at the current time point.

[0027] Furthermore, the calculation module is further configured to include, in the step of calculating the impact data on the number of subjects based on the subject count data, and calculating the impact data on the trial start time based on the trial time data, the following steps are taken:

[0028] Calculate the current stage's participant recruitment gap data based on the number of identified participants and the total number of pre-selected participants in the current phase of the drug clinical trial;

[0029] The impact data on subject resources at the current stage are calculated based on the number of identified subjects, the number of subjects remaining in the subject pool to be screened, and the total number of pre-selected subjects at the current stage of the drug clinical trial.

[0030] The impact data on the number of trials initiated were obtained based on the current stage participant recruitment gap data and the current stage participant resource impact data.

[0031] Furthermore, the determining module is further configured to acquire historical trial data and determine historical comparison data for trial initiation based on the historical trial data; the historical trial data includes the number of subjects required for other trials in the same historical period and the remaining time for other trials in the same historical period, including:

[0032] Calculate the historical average number of subjects required based on the number of subjects required in other trials during the same historical period;

[0033] The median remaining time in history was determined based on the remaining time of other trials in the same historical period.

[0034] Historical comparative data for trial initiation were determined based on the remaining time of the current trial period, the historical average number of participants required, and the median remaining time in history.

[0035] Furthermore, the output module is further configured to output trial initiation necessity data based on the trial initiation quantity impact data, the trial initiation time impact data, and the trial initiation history comparison data; the trial initiation necessity data characterizes the necessity of starting the drug clinical trial at the current time point, including:

[0036]

[0037] E need =TE

[0038] In the formula, TINI represents the necessity data for initiating the experiment; S represents the impact data of the number of experiments initiated. This data represents the current recruitment gap for test takers. This data represents the impact of current participant resources, where E is the number of identified participants, T is the total number of pre-selected participants, and R is the number of remaining participants in the participant pool awaiting screening; L represents historical comparison data from the trial initiation. need To determine the number of subjects still needing to be recruited, H e H represents the historical average number of subjects required. t The median remaining historical time; T left The remaining time of the current test period; K1 and K2 are the preset first quantity weight and preset second quantity weight, respectively.

[0039] Furthermore, the output module is further configured such that K1+K2=1.

[0040] It should be understood that the description in the Summary Section is not intended to limit the key or essential features of the embodiments of this application, nor is it intended to restrict the scope of this application. Other features of this application will become readily apparent from the following description. Attached Figure Description

[0041] The above and other features, advantages, and aspects of the embodiments of this application will become more apparent from the accompanying drawings and the following detailed description. In the drawings, the same or similar reference numerals denote the same or similar elements, wherein:

[0042] Figure 1 A flowchart of a trial selection research method according to an embodiment of this application is shown;

[0043] Figure 2 A block diagram of a trial selection research system according to an embodiment of this application is shown. Detailed Implementation

[0044] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0045] Furthermore, the term "and / or" in this article is merely a description of the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent: A existing alone, A and B existing simultaneously, or B existing alone. Additionally, the character " / " in this article generally indicates that the preceding and following related objects have an "or" relationship.

[0046] This application provides a method and system for selecting experimental studies, which can ensure that experiments are completed on time and improve experimental efficiency.

[0047] Firstly, this application provides a research method for experimental selection. (Reference) Figure 1 The specific steps included in the method are as follows.

[0048] Step S110: Obtain subject number data and trial time data; the subject number data includes the number of identified subjects in the current stage of the drug clinical trial, the total number of pre-selected subjects, and the number of subjects remaining to be screened in the subject pool; the trial time data is the remaining time of the current trial period.

[0049] In this embodiment, the screening method for subjects in the drug clinical trial is rolling enrollment. This means that a portion of subjects are screened to participate in the trial, and while these subjects are being tested, the remaining subjects are also screened. The number of confirmed subjects mentioned here refers to the number of eligible subjects screened at the current time point in the current phase of the drug clinical trial. It is understood that in typical drug clinical trials, there are generally four phases. For each subject, the entire trial process includes the treatment period and the follow-up period, and the duration of the entire treatment process is predictable. Generally, the duration of the entire treatment process for each subject is roughly the same. Regarding the above description, although rolling enrollment is used in drug clinical trials, the required total number of subjects is generally divided into two or three groups, rarely more. This would prolong the current phase of the drug clinical trial, thus affecting the trial completion time and efficiency. The total number of pre-selected subjects here refers to the total number of subjects required for the current phase of the drug clinical trial. For example, if a Phase II drug clinical trial requires 400 subjects, using rolling enrollment, the first group selects 180 subjects, and the second group selects 220 subjects.

[0050] In actual drug clinical trials, the teams, laboratories, or companies conducting the trials typically collaborate with specific hospitals. Based on the disease requirements of the investigational drug, a pool of subjects is created. This pool includes patients from these collaborating hospitals who meet the disease requirements. The medical records and related data of these patients are directly added to the subject pool to facilitate subject selection. If the number of subjects in the pool is insufficient to meet the trial requirements, subjects need to be recruited from other sources. Generally, subjects are recruited from the subject pool first. The remaining number of subjects to be screened in the subject pool refers to the number of subjects remaining in the pool at the current time point.

[0051] Step S120: Calculate the impact data of the number of subjects starting the trial based on the subject count data, and calculate the impact data of the trial start time based on the trial time data.

[0052] In this embodiment of the application, calculating the impact data on the number of trials initiated based on the subject number data and calculating the impact data on the trial initiation time based on the trial time data specifically includes: calculating the subject recruitment gap data for the current stage based on the number of identified subjects and the total number of pre-selected subjects in the current stage of the drug clinical trial; calculating the impact data on subject resources for the current stage based on the number of identified subjects, the number of subjects remaining in the subject pool to be screened, and the total number of pre-selected subjects in the current stage of the drug clinical trial; and obtaining the impact data on the number of trials initiated based on the subject recruitment gap data and the impact data on subject resources for the current stage.

[0053] Step S130: Obtain historical trial data and determine historical comparison data for trial initiation based on the historical trial data; the historical trial data includes the number of subjects required for other trials in the same historical period and the remaining time for other trials in the same historical period.

[0054] In this embodiment of the application, determining the historical comparative data for trial initiation based on the historical trial data specifically includes: calculating the historical average number of subjects required based on the number of subjects required by other trials in the same historical period; determining the median of the remaining time in the historical period based on the remaining time in other trials in the same historical period; and determining the historical comparative data for trial initiation based on the remaining time in the current trial period, the historical average number of subjects required, and the median of the remaining time in the historical period.

[0055] It is understandable that the historical trial data here refers to the historical trial data of trials that are labeled with the ongoing drug clinical trials; for example, two drug clinical trials are both for drugs targeting heart disease.

[0056] Step S140: Output trial initiation necessity data based on the trial initiation quantity impact data, the trial initiation time impact data, and the trial initiation history comparison data; the trial initiation necessity data characterizes the necessity of starting the drug clinical trial at the current time point.

[0057] In this embodiment of the application, the output of test initiation necessity data based on the test initiation quantity impact data, the test initiation time impact data, and the test initiation history comparison data specifically includes:

[0058]

[0059]

[0060] E need =TE

[0061] In the formula, TINI represents the necessity data for initiating the experiment; S represents the impact data of the number of experiments initiated. This data represents the current recruitment gap for test takers. This data represents the impact of current participant resources, where E is the number of identified participants, T is the total number of pre-selected participants, and R is the number of remaining participants in the participant pool awaiting screening; L represents historical comparison data from the trial initiation. need To determine the number of subjects still needing to be recruited, H e H represents the historical average number of subjects required. t The median remaining historical time; T left K1 represents the remaining time of the current trial period; K2 represents the preset first quantity weight and the preset second quantity weight, respectively; where K1+K2=1.

[0062] Understandably, the data on the number of trials initiated here includes two parts. One part is the recruitment gap, which reflects the difference between the current recruitment progress and the target. A larger gap indicates a higher urgency for the trial, meaning a higher necessity to initiate it. The other part is the resource pressure on the participant pool, which reflects the current resource availability of the participant pool. If the number of participants remaining in the pool is sufficient, then... If the coefficient is close to 0, it indicates that the necessity of starting the trial is low. Conversely, if the number of subjects is small, it indicates that the pressure of subsequent recruitment is high. In this case, it is necessary to start the trial and recruit while conducting the trial to prevent the trial from being delayed due to long recruitment time.

[0063] The historical comparison data for trial initiation here compares the current trial progress with historical trials, using history as a benchmark to compare the current subject recruitment efficiency; here, it represents the historical recruitment capacity per unit time, and here, it represents the recruitment rate required for the current trial; if the ratio is greater than 1, it means that the historical efficiency is better than the current demand, that is, the current required recruitment rate is not greater than the historical required recruitment rate, and the urgency is low, and the necessity of initiating the trial is low; here, logarithmic compression is used to avoid the dominance of extreme values.

[0064] And that The "partial" indicates time sensitivity; the shorter the remaining time, the higher the necessity, and vice versa.

[0065] The necessity data for starting the experiment is obtained by calculation. The higher the data, the higher the necessity of starting the experiment, and vice versa.

[0066] In this embodiment of the application, the determination of whether to start the experiment can be made by comparing the necessity data for starting the experiment with a preset necessity threshold. If the necessity data for starting the experiment is not less than the preset necessity threshold, then it is determined that the experiment should be started.

[0067] Assuming the trial needs to be initiated, the recruitment of subsequent participants can be conducted in the following ways.

[0068] Specifically, in this scheme, failure subject case data of other trials in the same period and stage are obtained based on historical trial data; the failure subject case data includes the failure time nodes of the failure subjects; based on the failure time nodes of the failure subjects, the failure time node data is determined by cluster analysis; and the number of failure subjects corresponding to the failure time node data is determined; based on the number of failure subjects, the number of subjects to be recruited in the next batch with the highest priority is determined.

[0069] Understandably, by analyzing historical data from other similar trials and using cluster analysis, the failure time points of failed subjects can be determined. These time points may include subjects withdrawing from the trial or losing their access records during follow-up. Cluster analysis can then be used to determine the number of failures at each failure time point, and based on this, the number of highest priority subjects to be recruited in the next batch can be determined.

[0070] In this way, after determining the number of participants in the first batch of trials, recruitment can be scheduled based on the failure time points obtained from cluster analysis, thereby ensuring the trial can proceed and the number of participants can be guaranteed.

[0071] It should be noted that, for the sake of simplicity, the foregoing method embodiments are all described as a series of actions. However, those skilled in the art should understand that this application is not limited to the described order of actions, because according to the embodiments of this application, some steps can be performed in other orders or simultaneously. Furthermore, those skilled in the art should also understand that the embodiments described in the specification are all optional embodiments, and the actions and modules involved are not necessarily essential to this application.

[0072] Secondly, this application provides an experimental selection research system. For example... Figure 2 As shown, the system includes an acquisition module 210, used to acquire subject number data and trial time data; the subject number data includes the number of identified subjects in the current stage of the drug clinical trial, the total number of pre-selected subjects, and the number of subjects remaining to be screened in the subject pool; the trial time data is the remaining time of the current trial period;

[0073] Calculation module 220 is used to calculate the impact data of the number of subjects starting the trial based on the subject number data, and to calculate the impact data of the trial start time based on the trial time data;

[0074] The determination module 230 is used to acquire historical trial data and determine historical comparison data for trial initiation based on the historical trial data; the historical trial data includes the number of subjects required for other trials in the same historical period and the remaining time for other trials in the same historical period;

[0075] The output module 240 is used to output trial initiation necessity data based on the trial initiation quantity impact data, the trial initiation time impact data, and the trial initiation history comparison data; the trial initiation necessity data characterizes the degree of necessity for starting the drug clinical trial at the current time point.

[0076] Furthermore, the calculation module 220 is further configured to include, in the step of calculating the impact data on the number of subjects based on the subject count data, and calculating the impact data on the trial start time based on the trial time data, the following steps are taken:

[0077] Calculate the current stage's participant recruitment gap data based on the number of identified participants and the total number of pre-selected participants in the current phase of the drug clinical trial;

[0078] The impact data on subject resources at the current stage are calculated based on the number of identified subjects, the number of subjects remaining in the subject pool to be screened, and the total number of pre-selected subjects at the current stage of the drug clinical trial.

[0079] The impact data on the number of trials initiated were obtained based on the current stage participant recruitment gap data and the current stage participant resource impact data.

[0080] Furthermore, the determining module 230 is further configured to acquire historical trial data and determine historical comparison data for trial initiation based on the historical trial data; the historical trial data includes the number of subjects required for other trials in the same historical period and the remaining time for other trials in the same historical period, including:

[0081] Calculate the historical average number of subjects required based on the number of subjects required in other trials during the same historical period;

[0082] The median remaining time in history was determined based on the remaining time of other trials in the same historical period.

[0083] Historical comparative data for trial initiation were determined based on the remaining time of the current trial period, the historical average number of participants required, and the median remaining time in history.

[0084] Furthermore, the output module 240 is further configured to output trial initiation necessity data based on the trial initiation quantity impact data, the trial initiation time impact data, and the trial initiation history comparison data; the trial initiation necessity data characterizes the necessity of starting the drug clinical trial at the current time point, including:

[0085]

[0086] E need =TE

[0087] In the formula, TINI represents the necessity data for initiating the experiment; S represents the impact data of the number of experiments initiated. This data represents the current recruitment gap for test takers. This data represents the impact of current participant resources, where E is the number of identified participants, T is the total number of pre-selected participants, and R is the number of remaining participants in the participant pool awaiting screening; L represents historical comparison data from the trial initiation. need To determine the number of subjects still needing to be recruited, H e H represents the historical average number of subjects required. t The median remaining historical time; T left The remaining time of the current test period; K1 and K2 are the preset first quantity weight and preset second quantity weight, respectively.

[0088] Furthermore, the output module 240 is further configured such that K1+K2=1.

[0089] Those skilled in the art will understand that, for the sake of convenience and brevity, the specific working process of the described device can be referred to the corresponding process in the foregoing method embodiments, and will not be repeated here.

[0090] The above description is merely a preferred embodiment of this application and an explanation of the technical principles employed. Those skilled in the art should understand that the scope of disclosure in this application is not limited to technical solutions formed by specific combinations of the above-described technical features, but should also cover other technical solutions formed by arbitrary combinations of the above-described technical features or their equivalents without departing from the foregoing disclosed concept. For example, technical solutions formed by substituting the above features with (but not limited to) technical features with similar functions disclosed in this application.

Claims

1. A method of research for test selection, characterized in that, include: Acquire subject number data and trial time data; the subject number data includes the number of identified subjects in the current stage of the drug clinical trial, the total number of pre-selected subjects, and the number of subjects remaining in the subject pool to be screened; the trial time data is the remaining time of the current trial period; The impact data on the number of subjects initiated is calculated based on the subject count data, and the impact data on the trial start time is calculated based on the trial time data. Acquire historical trial data and determine historical comparison data for trial initiation based on the historical trial data; the historical trial data includes the number of subjects required for other trials in the same historical period and the remaining time for other trials in the same historical period; Based on the data on the impact of the number of trials initiated, the data on the impact of the trial initiation time, and the historical comparison data of trial initiation, the necessity data for initiating trials is output; the necessity data for initiating trials represents the degree of necessity for starting a drug clinical trial at the current time point. The calculation of the impact data on the number of participants based on the subject count data, and the calculation of the impact data on the trial start time based on the trial time data, include: Calculate the current stage's participant recruitment gap data based on the number of identified participants and the total number of pre-selected participants in the current phase of the drug clinical trial; The impact data on subject resources at the current stage are calculated based on the number of identified subjects, the number of subjects remaining in the subject pool to be screened, and the total number of pre-selected subjects at the current stage of the drug clinical trial. Based on the current stage participant recruitment gap data and the current stage participant resource impact data, we obtain the trial initiation number impact data; The system outputs trial initiation necessity data based on the data affecting the number of trials initiated, the data affecting the trial initiation time, and the historical comparison data of trial initiation. This trial initiation necessity data characterizes the degree of necessity for starting the drug clinical trial at the current time point, including: In the formula, Necessary data for initiating the experiment; To determine the impact of the number of trials initiated on the data, This data represents the current recruitment gap for test takers. Data on the impact of current participant resources. The number of subjects has been determined. The total number of pre-selected subjects, This represents the number of remaining subjects to be screened in the subject pool. Historical comparison data was used to initiate the experiment. To determine the number of subjects still needing to be recruited, This represents the historical average number of subjects required. This represents the median remaining historical time. This represents the remaining time of the current trial period. , These are the preset first quantity weight and the preset second quantity weight, respectively; 。 2. The method according to claim 1, characterized in that, The process involves acquiring historical trial data and determining historical comparison data for trial initiation based on this data. The historical trial data includes the number of subjects required for other trials in the same historical phase and the remaining time for those trials. Calculate the historical average number of subjects required based on the number of subjects required in other trials during the same historical period; The median remaining time in history was determined based on the remaining time of other trials in the same historical period. Historical comparative data for trial initiation were determined based on the remaining time of the current trial period, the historical average number of participants required, and the median remaining time in history.

3. A system for selecting and researching experiments, characterized in that, include: The acquisition module (210) is used to acquire data on the number of subjects and the trial time. The subject number data includes the number of identified subjects in the current phase of the drug clinical trial, the total number of pre-selected subjects, and the number of subjects remaining in the subject pool to be screened; the trial time data is the remaining time of the current trial period; The calculation module (220) is used to calculate the impact data of the number of subjects on the trial initiation based on the subject number data, and to calculate the impact data of the trial initiation time based on the trial time data; The determination module (230) is used to acquire historical trial data and determine historical comparison data for trial initiation based on the historical trial data; the historical trial data includes the number of subjects required for other trials in the same historical period and the remaining time for other trials in the same historical period; The output module (240) is used to output trial initiation necessity data based on the trial initiation quantity impact data, the trial initiation time impact data, and the trial initiation history comparison data; the trial initiation necessity data characterizes the degree of necessity for starting the drug clinical trial at the current time point; The calculation module (220) is further configured to include, in the step of calculating the impact data on the number of subjects based on the subject count data, and calculating the impact data on the trial start time based on the trial time data, the following steps are taken: Calculate the current stage's participant recruitment gap data based on the number of identified participants and the total number of pre-selected participants in the current phase of the drug clinical trial; The impact data on subject resources at the current stage are calculated based on the number of identified subjects, the number of subjects remaining in the subject pool to be screened, and the total number of pre-selected subjects at the current stage of the drug clinical trial. Based on the current stage participant recruitment gap data and the current stage participant resource impact data, we obtain the trial initiation number impact data; The output module (240) is further configured to output trial initiation necessity data based on the trial initiation quantity impact data, the trial initiation time impact data, and the trial initiation history comparison data; the trial initiation necessity data characterizes the necessity of starting the drug clinical trial at the current time point, including: In the formula, Necessary data for initiating the experiment; To determine the impact of the number of trials initiated on the data, This data represents the current recruitment gap for test takers. Data on the impact of current participant resources. The number of subjects has been determined. The total number of pre-selected subjects, This represents the number of remaining subjects to be screened in the subject pool. Historical comparison data was used to initiate the experiment. To determine the number of subjects still needing to be recruited, This represents the historical average number of subjects required. This represents the median remaining historical time. This represents the remaining time of the current trial period. , These are the preset first quantity weight and the preset second quantity weight, respectively; The output module (240) is further configured to, .

4. The system according to claim 3, characterized in that, The determining module (230) is further configured to acquire historical trial data and determine historical comparison data for trial initiation based on the historical trial data; the historical trial data includes the number of subjects required for other trials in the same historical period and the remaining time for other trials in the same historical period, including: Calculate the historical average number of subjects required based on the number of subjects required in other trials during the same historical period; The median remaining time in history was determined based on the remaining time of other trials in the same historical period. Historical comparative data for trial initiation were determined based on the remaining time of the current trial period, the historical average number of participants required, and the median remaining time in history.

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