Test selection research method and system

Abstract

The invention provides a test selection research method and system, and belongs to the technical field of test selection. The method comprises the following steps: acquiring quantity data of subjects and test time data; calculating test starting quantity influence data according to the subject quantity data, and calculating test starting time influence data according to the test time data; acquiring historical test data, and determining test starting historical comparison data according to the historical test data; outputting test starting necessity data according to the test starting number influence data, the test starting time influence data and the test starting historical comparison data; by the adoption of the scheme, it is guaranteed that the test is completed on schedule, and the effective degree of the test is improved.

Description

Technical Field

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

[0002] In the process of drug clinical trials, it is usually divided into four phases. The goals of each phase of drug clinical trials are different, the overall trial time is long, and the screening conditions for subjects in each phase are different. For the subjects as the objects of clinical trials, using drugs to treat the subjects and tracking and following up are necessary steps throughout the entire clinical trial process. And as the subjects are of utmost importance, their screening is also a very important process. Before each phase of drug clinical trials, the subjects will be screened to obtain qualified subjects to participate in the drug clinical trials. However, in the actual process of each phase of drug clinical trials, the number of subjects required is uncertain, and the method of starting the drug clinical trials after recruiting the required number of subjects will result in a longer overall trial time, exceeding the expected trial time. Therefore, in order to ensure the efficiency of drug clinical trials, a rolling enrollment method is often adopted, that is, first screening a certain number of subjects to participate in the drug clinical trials, and at the same time as the trial, recruiting the next batch of subjects. This method can ensure the completion time and efficiency of the trial. Summary of the Invention

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

[0004] In a first aspect, the present application provides a research method for trial selection. The method comprises:

[0005] Obtain data on the number of subjects and trial duration; the data on the number of subjects includes the number of confirmed 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 duration data is the remaining time of the current trial period;

[0006] Calculate the trial start quantity impact data based on the subject number data, and calculate the trial start time impact data based on the trial time data;

[0007] Obtaining historical trial data and determining trial initiation historical comparative data based on the historical trial data; the historical trial data includes the number of subjects required for other trials at the same historical stage and the remaining time for other trials at the same historical stage;

[0008] The trial initiation necessity data is output 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 represents the necessity of starting the trial at the current time node of the drug clinical trial.

[0009] Furthermore, the calculating of the trial start quantity impact data based on the subject quantity data and the calculating of the trial start time impact data based on the trial time data include:

[0010] Calculate the subject recruitment gap data for the current stage based on the number of confirmed subjects and the total number of pre-selected subjects for the current stage of the drug clinical trial;

[0011] Calculate the subject resource impact data for the current stage based on the number of confirmed subjects in the current stage of the drug clinical trial, the number of subjects remaining to be screened in the subject pool, and the total number of pre-selected subjects;

[0012] The trial initiation quantity impact data is obtained based on the subject recruitment gap data of the current stage and the subject resource impact data of the current stage.

[0013] Furthermore, the acquisition of historical test data and the determination of test initiation historical comparison data based on the historical test data; the historical test data including the number of subjects required for other tests at the same historical stage and the remaining time of other tests at the same historical stage include:

[0014] Calculate the historical average number of subjects required based on the number of subjects required for other trials at the same stage in the history;

[0015] Determine the median of the historical remaining time based on the remaining time of other trials in the same historical stage;

[0016] The historical comparative data for trial initiation is determined based on the remaining time of the current trial period, the historical average number of subjects required, and the historical median remaining time.

[0017] Furthermore, the output of the 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 characterizing the degree of necessity of starting the trial at the current time point of the drug clinical trial includes:

[0018]

[0019] E need =TE

[0020] Where TINI is the necessity data of test start-up; S is the impact data of the number of test starts, Recruitment gap data for current phase subjects, is the impact data of subject resources at the current stage, E is the number of confirmed subjects, T is the total number of pre-selected subjects, R is the number of subjects remaining to be screened in the subject pool; L is the historical comparison data of the trial start, E need is the number of subjects still to be recruited, H e is the historical average number of subjects required, H t is the median of the remaining time in history; T left is the remaining time of the current trial period; K1 and K2 are the preset first quantity weight and the preset second quantity weight respectively.

[0021] Furthermore, K1+K2=1.

[0022] In a second aspect, the present application provides a test selection research system. The system includes:

[0023] An acquisition module is used to obtain data on the number of subjects and trial time; the data on the number of subjects includes the number of confirmed 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] a calculation module, configured to calculate the trial start quantity impact data based on the subject number data, and calculate the trial start time impact data based on the trial time data;

[0025] A determination module is used to obtain historical test data and determine the historical comparison data of the test start based on the historical test data; the historical test data includes the number of subjects required for other tests at the same stage in the history and the remaining time of other tests at the same stage in the history;

[0026] An 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 represents the necessity of starting the trial at the current time node of the drug clinical trial.

[0027] Furthermore, the calculation module is further configured to calculate the trial start quantity impact data based on the subject number data and calculate the trial start time impact data based on the trial time data, including:

[0028] Calculate the subject recruitment gap data for the current stage based on the number of confirmed subjects and the total number of pre-selected subjects for the current stage of the drug clinical trial;

[0029] Calculate the subject resource impact data for the current stage based on the number of confirmed subjects in the current stage of the drug clinical trial, the number of subjects remaining to be screened in the subject pool, and the total number of pre-selected subjects;

[0030] The trial initiation quantity impact data is obtained based on the subject recruitment gap data of the current stage and the subject resource impact data of the current stage.

[0031] Furthermore, the determination module is further configured to obtain historical test data and determine the test initiation historical comparison data based on the historical test data; the historical test data includes the number of subjects required for other tests at the same stage in the history and the remaining time of other tests at the same stage in the history, including:

[0032] Calculate the historical average number of subjects required based on the number of subjects required for other trials at the same stage in the history;

[0033] Determine the median of the historical remaining time based on the remaining time of other trials in the same historical stage;

[0034] The historical comparative data for trial initiation is determined based on the remaining time of the current trial period, the historical average number of subjects required, and the historical median remaining time.

[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 characterizing the degree of necessity of starting the drug clinical trial at the current time node includes:

[0036]

[0037] E need =TE

[0038] Where TINI is the necessity data of test start-up; S is the impact data of the number of test starts, Recruitment gap data for current phase subjects, is the impact data of subject resources at the current stage, E is the number of confirmed subjects, T is the total number of pre-selected subjects, R is the number of subjects remaining to be screened in the subject pool; L is the historical comparison data of the trial start, E need is the number of subjects still to be recruited, H e is the historical average number of subjects required, H t is the median of the remaining time in history; T left is the remaining time of the current trial period; K1 and K2 are the preset first quantity weight and the preset second quantity weight respectively.

[0039] Furthermore, the output module is further configured as follows: K1+K2=1.

[0040] It should be understood that the contents described in the Summary of the Invention are not intended to limit the key or important features of the embodiments of the present application, nor are they intended to limit the scope of the present application. Other features of the present application will become readily understood through the following description. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] The above and other features, advantages and aspects of the embodiments of the present application will become more apparent with reference to the following detailed description in conjunction with the accompanying drawings. In the accompanying drawings, the same or similar reference numerals represent the same or similar elements, wherein:

[0042] Figure 1 A flow chart showing a method for selecting a test subject in an embodiment of the present invention is shown;

[0043] Figure 2 A block diagram of a test selection research system in an embodiment of the present application is shown. DETAILED DESCRIPTION

[0044] To make the purpose, technical solutions, and advantages of the embodiments of this application more clear, the technical solutions in the embodiments of this application will be clearly and completely described below in conjunction with the drawings in the embodiments of this application. Obviously, the described embodiments are part of the embodiments of this application, not all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of this application.

[0045] In this document, the term "and / or" simply describes a relationship between related objects, indicating that three possible relationships exist. For example, "A and / or B" can represent: A exists alone, A and B exist simultaneously, or B exists alone. Furthermore, the character " / " in this document generally indicates that the related objects are in an "or" relationship.

[0046] This application provides a trial selection research method and system, which can ensure that the trial is completed on time and improve trial efficiency.

[0047] In the first aspect, this application provides a research method for trial selection. 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 confirmed subjects in the current stage of the drug clinical trial, the total number of pre-selected subjects, and the number of remaining subjects to be screened in the subject pool; the trial time data is the remaining time of the current trial period.

[0049] In the embodiments of the present application, the screening method for subjects in the drug clinical trial is rolling enrollment, that is, a portion of subjects are first screened to participate in the trial, and while the trial is being conducted on these subjects, the remaining subjects are screened; the number of determined subjects mentioned here is the number of eligible subjects screened at the current time point of the current stage of the drug clinical trial; it is understandable that in general drug clinical trials, they are generally divided into four phases, and for each subject, the entire process of participating in the trial includes a treatment period and a follow-up period, and the time of the entire treatment process is predictable. Generally speaking, the duration of the entire treatment process for each subject is basically the same; with respect to the above description, when a drug clinical trial is conducted using a rolling enrollment method, although it is a rolling enrollment method, the total number of subjects required is generally divided into two or three groups, and basically no more groups are divided. This will result in the current drug clinical trial being prolonged, thereby affecting the trial completion time and trial efficiency; the total number of pre-selected subjects here is the total number of subjects required for the current drug clinical trial. For example, if a second phase drug clinical trial requires 400 subjects to participate in the trial in advance, a rolling enrollment method is adopted, with 180 subjects selected for the first group and 220 subjects selected for the second group.

[0050] In actual drug clinical trials, the executors such as the trial team, laboratory, or company generally cooperate with fixed hospitals to arrange a subject pool based on the disease requirements of the trial drug. The subject pool includes patients who meet the disease requirements in these cooperative hospitals, and the medical records and related data of these patients are directly entered into the subject pool to facilitate the screening of subjects for the trial. If the number of subjects in the subject pool does not meet the trial requirements, it is necessary to recruit subjects from other channels; and generally, the recruitment of subjects for trials gives priority to recruiting subjects from the subject pool; the number of subjects remaining to be screened in the subject pool here refers to the number of subjects remaining in the subject pool at the current time node.

[0051] Step S120: Calculate the experiment start quantity impact data based on the subject quantity data, and calculate the experiment start time impact data based on the experiment time data.

[0052] In an embodiment of the present application, calculating the trial initiation quantity impact data based on the subject number data and calculating the trial initiation time impact data based on the trial time data specifically include: calculating the subject recruitment gap data for the current stage based on the determined number of subjects and the pre-selected total number of subjects in the current stage of the drug clinical trial; calculating the subject resource impact data for the current stage based on the determined number of subjects in the current stage of the drug clinical trial, the remaining number of subjects to be screened in the subject pool, and the pre-selected total number of subjects; and obtaining the trial initiation quantity impact data based on the subject recruitment gap data for the current stage and the subject resource impact data for the current stage.

[0053] Step S130: Acquire historical test data, and determine the test start historical comparison data based on the historical test data; the historical test data includes the number of subjects required for other tests in the same historical stage and the remaining time of other tests in the same historical stage.

[0054] In an embodiment of the present 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 for other trials in the same historical stage; determining the median of the historical remaining time based on the remaining time of other trials in the same historical stage; and determining the historical comparative data for trial initiation based on the remaining time of the current trial period, the historical average number of subjects required, and the median of the historical remaining time.

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

[0056] Step S140: 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 represents the degree of necessity for starting the trial at the current time node of the drug clinical trial.

[0057] In an embodiment of the present application, outputting the test start necessity data according to the test start quantity impact data, the test start time impact data, and the test start history comparison data specifically includes:

[0058]

[0059]

[0060] E need =TE

[0061] Where TINI is the necessity data of test start-up; S is the impact data of the number of test starts, Recruitment gap data for current phase subjects, is the impact data of subject resources at the current stage, E is the number of confirmed subjects, T is the total number of pre-selected subjects, R is the number of subjects remaining to be screened in the subject pool; L is the historical comparison data of the trial start, E need is the number of subjects still to be recruited, H e is the historical average number of subjects required, H t is the median of the remaining time in history; T left is the remaining time of the current trial period; K1 and K2 are the preset first quantity weight and the preset second quantity weight respectively; where K1+K2=1.

[0062] It is understandable that the data on the impact of the number of trial launches here includes two parts. One part is the recruitment gap, which reflects the gap between the current progress of recruiting subjects and the target. The larger the gap, the higher the urgency of the trial, that is, the more necessary it is to launch the trial. The other part is the resource pressure of the subject pool, which reflects the resources that the current subject pool can provide. If the number of subjects remaining in the subject pool is sufficient, then If the coefficient is close to 0, it means that there is a low necessity to start the trial. On the contrary, if the number of subjects is small, it means that the subsequent recruitment pressure is high. In this case, it is necessary to start the trial and recruit while the trial is being conducted to prevent the trial from being delayed due to a long recruitment time.

[0063] The historical comparison data of the trial launch here compares the progress of the current trial with the historical trial, and compares the current subject recruitment efficiency with the history as the benchmark; the here represents the historical recruitment capacity per unit time, and the here 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, then the urgency is lower and the necessity of trial launch is lower; logarithmic compression is used here to avoid the dominance of extreme values.

[0064] And the The part indicates time sensitivity. The shorter the remaining time, the higher the necessity, and vice versa.

[0065] The necessity data of test initiation is obtained by calculation. The higher the data, the more necessary the test initiation is, and vice versa.

[0066] In an embodiment of the present application, to determine whether a test should be started, the test start necessity data may be compared with a preset necessity threshold. If the test start necessity data is not less than the preset necessity threshold, it is determined that the test should be started.

[0067] On the premise that it is determined that the trial needs to be initiated, the following methods can be used to recruit subsequent subjects.

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

[0069] It is understandable that by analyzing historical data of other trials of the same type and using cluster analysis, the failure time nodes of failed subjects can be determined. This time node may be when the subject does not participate in the trial and withdraws, or when the subject loses access records during the follow-up period; cluster analysis is used to determine the number of losers corresponding to each failure time node, and based on this, the number of subjects with the highest priority to be recruited in the next batch can be determined.

[0070] In this way, after determining the number of test subjects in the first batch, the recruitment progress can be arranged based on the various failure time nodes obtained by cluster analysis, thereby ensuring the progress of the trial and the number of subjects.

[0071] It should be noted that for the aforementioned method embodiments, for the sake of simplicity, they are all expressed as a series of action combinations, but those skilled in the art should be aware that this application is not limited by the order of the actions described, because according to the embodiments of this application, certain steps can be performed in other orders or simultaneously. Secondly, those skilled in the art should also be aware that the embodiments described in the specification are all optional embodiments, and the actions and modules involved are not necessarily required for this application.

[0072] In the second aspect, this application provides a test selection research system. Figure 2 As shown, the system includes an acquisition module 210 for acquiring subject number data and trial time data; the subject number data includes the number of confirmed 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] A calculation module 220, configured to calculate the trial start quantity impact data based on the subject number data, and calculate the trial start time impact data based on the trial time data;

[0074] Determination module 230, for obtaining historical test data and determining test initiation historical comparison data based on the historical test data; the historical test data includes the number of subjects required for other tests at the same stage in the history and the remaining time of other tests at the same stage in the history;

[0075] The output module 240 is used to output the 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 represents the necessity of starting the trial at the current time node of the drug clinical trial.

[0076] Furthermore, the calculation module 220 is further configured to calculate the trial start quantity impact data based on the subject quantity data and calculate the trial start time impact data based on the trial time data, including:

[0077] Calculate the subject recruitment gap data for the current stage based on the number of confirmed subjects and the total number of pre-selected subjects for the current stage of the drug clinical trial;

[0078] Calculate the subject resource impact data for the current stage based on the number of confirmed subjects in the current stage of the drug clinical trial, the number of subjects remaining to be screened in the subject pool, and the total number of pre-selected subjects;

[0079] The trial initiation quantity impact data is obtained based on the subject recruitment gap data of the current stage and the subject resource impact data of the current stage.

[0080] Furthermore, the determination module 230 is further configured to obtain historical test data and determine the test initiation historical comparison data based on the historical test data; the historical test data includes the number of subjects required for other tests at the same stage in the history and the remaining time of other tests at the same stage in the history, including:

[0081] Calculate the historical average number of subjects required based on the number of subjects required for other trials at the same stage in the history;

[0082] Determine the median of the historical remaining time based on the remaining time of other trials in the same historical stage;

[0083] The historical comparative data for trial initiation is determined based on the remaining time of the current trial period, the historical average number of subjects required, and the historical median remaining time.

[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 representing the degree of necessity of starting the drug clinical trial at the current time node includes:

[0085]

[0086] E need =TE

[0087] Where TINI is the necessity data of test start-up; S is the impact data of the number of test starts, Recruitment gap data for current phase subjects, is the impact data of subject resources at the current stage, E is the number of confirmed subjects, T is the total number of pre-selected subjects, R is the number of subjects remaining to be screened in the subject pool; L is the historical comparison data of the trial start, E need is the number of subjects still to be recruited, H e is the historical average number of subjects required, H t is the median of the remaining time in history; T left is the remaining time of the current trial period; K1 and K2 are the preset first quantity weight and the preset second quantity weight respectively.

[0088] Furthermore, the output module 240 is further configured as follows: K1+K2=1.

[0089] Those skilled in the art can clearly understand that, for the convenience and brevity of description, the specific working process of the described device can refer to the corresponding process in the aforementioned method embodiment, and will not be repeated here.

[0090] The above description is merely a preferred embodiment of the present application and an illustration of the technical principles employed. Those skilled in the art should understand that the scope of disclosure in this application is not limited to the technical solutions formed by a specific combination of the above-mentioned technical features, but also encompasses other technical solutions formed by any combination of the above-mentioned technical features or their equivalents without departing from the aforementioned disclosed concepts. For example, a technical solution formed by replacing the above-mentioned features with (but not limited to) technical features with similar functions disclosed in this application.

Claims

1. A research method for trial selection, characterized in that: include: Obtain data on the number of subjects and trial duration; the data on the number of subjects includes the number of confirmed 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 duration data is the remaining time of the current trial period; Calculate the trial start quantity impact data based on the subject number data, and calculate the trial start time impact data based on the trial time data; Obtaining historical trial data and determining trial initiation historical comparative data based on the historical trial data; the historical trial data includes the number of subjects required for other trials at the same historical stage and the remaining time for other trials at the same historical stage; The trial initiation necessity data is output 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 represents the necessity of starting the trial at the current time node of the drug clinical trial.

2. The method according to claim 1, characterized in that Calculating the trial start quantity impact data based on the subject quantity data and calculating the trial start time impact data based on the trial time data includes: Calculate the subject recruitment gap data for the current stage based on the number of confirmed subjects and the total number of pre-selected subjects for the current stage of the drug clinical trial; Calculate the subject resource impact data for the current stage based on the number of confirmed subjects in the current stage of the drug clinical trial, the number of subjects remaining to be screened in the subject pool, and the total number of pre-selected subjects; The trial initiation quantity impact data is obtained based on the subject recruitment gap data of the current stage and the subject resource impact data of the current stage.

3. The method according to claim 2, characterized in that The acquisition of historical test data and determination of test initiation historical comparison data based on the historical test data; the historical test data including the number of subjects required for other tests at the same historical stage and the remaining time of other tests at the same historical stage include: Calculate the historical average number of subjects required based on the number of subjects required for other trials at the same stage in the history; Determine the median of the historical remaining time based on the remaining time of other trials in the same historical stage; The historical comparative data for trial initiation is determined based on the remaining time of the current trial period, the historical average number of subjects required, and the historical median remaining time.

4. The method according to claim 3, characterized in that Outputting the test start necessity data according to the test start quantity impact data, the test start time impact data and the test start history comparison data; The trial initiation necessity data characterizes the degree of necessity for starting the drug clinical trial at the current time point and includes: AND need =TE Where TINI is the necessity data of test start-up; S is the impact data of the number of test starts, Recruitment gap data for current phase subjects, = is the impact data of subject resources at the current stage, E is the number of confirmed subjects, T is the total number of pre-selected subjects, R is the number of subjects remaining to be screened in the subject pool; L is the historical comparison data of the trial start, E need is the number of subjects still to be recruited, H e is the historical average number of subjects required, H t is the median of the remaining time in history; T left is the remaining time of the current trial period; K1 and K2 are the preset first quantity weight and the preset second quantity weight respectively.

5. The method according to claim 4, characterized in that K1+K2=1.

6. A test selection research system, characterized in that: include: An acquisition module (210) is used to acquire data on the number of subjects and test time; The subject number data includes the number of confirmed 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; A calculation module (220) is used to calculate the experiment start quantity impact data based on the subject quantity data, and calculate the experiment start time impact data based on the experiment time data; A determination module (230) is used to obtain historical test data and determine the test start historical comparison data based on the historical test data; the historical test data includes the number of subjects required for other tests at the same historical stage and the remaining time of other tests at the same historical stage; An 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 represents the degree of necessity for starting the trial at the current time node of the drug clinical trial.

7. The system according to claim 6, characterized in that The calculation module (220) is further configured to calculate the trial start quantity impact data based on the subject quantity data and calculate the trial start time impact data based on the trial time data, including: Calculate the subject recruitment gap data for the current stage based on the number of confirmed subjects and the total number of pre-selected subjects for the current stage of the drug clinical trial; Calculate the subject resource impact data for the current stage based on the number of confirmed subjects in the current stage of the drug clinical trial, the number of subjects remaining to be screened in the subject pool, and the total number of pre-selected subjects; The trial initiation quantity impact data is obtained based on the subject recruitment gap data of the current stage and the subject resource impact data of the current stage.

8. The system according to claim 7, characterized in that The determination module (230) is further configured to obtain historical test data and determine the test start historical comparison data based on the historical test data; the historical test data includes the number of subjects required for other tests at the same stage in the history and the remaining time of other tests at the same stage in the history, including: Calculate the historical average number of subjects required based on the number of subjects required for other trials at the same stage in the history; Determine the median of the historical remaining time based on the remaining time of other trials in the same historical stage; The historical comparative data for trial initiation is determined based on the remaining time of the current trial period, the historical average number of subjects required, and the historical median remaining time.

9. The system according to claim 8, characterized in that The output module (240) is further configured to output the test start necessity data according to the test start quantity impact data, the test start time impact data and the test start history comparison data; The trial initiation necessity data characterizes the degree of necessity for starting the drug clinical trial at the current time point and includes: AND need =TE Where TINI is the necessity data of test start-up; S is the impact data of the number of test starts, Recruitment gap data for current phase subjects, = is the impact data of subject resources at the current stage, E is the number of confirmed subjects, T is the total number of pre-selected subjects, R is the number of subjects remaining to be screened in the subject pool; L is the historical comparison data of the trial start, E need is the number of subjects still to be recruited, H e is the historical average number of subjects required, H t is the median of the remaining time in history; T left is the remaining time of the current trial period; K1 and K2 are the preset first quantity weight and the preset second quantity weight respectively.

10. The system according to claim 9, characterized in that The output module (240) is further configured such that K1+K2=1.

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