Method, system and device for generating clinical trial design scheme based on bridging design

Abstract

The present invention relates to the field of clinical trial technology, and specifically to a method, system and device for generating a clinical trial design scheme based on a bridging design. Among them, the method for generating a clinical trial design scheme based on a bridging design first obtains data in a bridging test, determines the basic elements of the clinical trial design scheme, determines a sample size calculation method for a bridging design strategy, calculates the bridging test data according to the sample size calculation method for the bridging design strategy, obtains a sample size calculation result for the bridging design strategy, and finally generates a clinical trial design scheme according to the basic elements of the clinical trial design scheme and the sample size calculation result for the bridging design strategy. In this way, by obtaining bridging test data and calculating the bridging test data according to the sample size calculation method to formulate a clinical trial design scheme, a clinical trial design scheme can be automatically generated, and the clinical trial design scheme is more comprehensive, thereby improving the success rate of clinical trials and the success rate of drug development.

Description

Technical Field

[0001] The present invention relates to the technical field of clinical trials, and in particular to a method, system and device for generating a clinical trial design scheme based on a bridging design. Background Art

[0002] Clinical trial refers to a systematic trial with human subjects (patients or healthy subjects) to discover or verify the clinical medicine, pharmacology and other pharmacodynamic effects, adverse reactions, or absorption, distribution, metabolism and excretion of an experimental drug, in order to determine the efficacy and safety of the drug.

[0003] A bridging study is a study conducted in a new region to provide pharmacodynamic or clinical data on effectiveness, safety, dosage, and dosing regimen in the new region, so that foreign clinical data can be extrapolated to the population in the new region. Bridging studies of effectiveness can provide additional pharmacokinetic information for the population in the new region. When a bridging study is not required to provide clinical efficacy data, a pharmacokinetic study conducted in the new region can be considered a bridging study.

[0004] The application of bridging studies allows the extrapolation of foreign clinical trial data to new regions when necessary. If the existing clinical data set meets the regulatory requirements of the new region, whether these foreign data can be accepted also depends on whether the data can be extrapolated to the population in the new region. When the regulatory agency or sponsor believes that ethnic factors may change the safety or efficacy of the drug in the population of the new region, the sponsor may need to obtain certain clinical data in the new region in order to extrapolate or bridge the clinical data between the two regions.

[0005] Currently, in the entire clinical trial industry, the generation of clinical trial design plans based on the data from bridging trials is done manually. Insufficient clinical trial design plans lead to the failure of clinical trials, reduced efficiency of clinical trials, and ultimately the failure of new drug development. Summary of the invention

[0006] In view of this, the purpose of the present invention is to provide a method, system and device for generating a clinical trial design plan based on a bridging trial, so as to overcome the problem that the current clinical trial design plan is manually generated through a bridging design strategy, the design plan of the clinical trial is insufficient, leading to the failure of the clinical trial, the efficiency of the clinical trial is reduced, and ultimately the failure of new drug development.

[0007] To achieve the above objectives, the present invention adopts the following technical solutions:

[0008] In a first aspect, the present application provides a method for generating a clinical trial design based on a bridging design, comprising:

[0009] Obtain bridge test data;

[0010] Determine the basic elements of the clinical trial design plan based on the bridging trial data and laws and regulations;

[0011] Determine the sample size calculation method for the bridging design strategy based on the basic elements of the clinical trial design plan;

[0012] Calculate the bridging test data according to the bridging design strategy sample size calculation method to obtain a bridging design strategy sample size calculation result;

[0013] A clinical trial design plan is generated based on the basic elements of the clinical trial design plan and the sample size calculation results of the bridging design strategy.

[0014] Furthermore, the method described above, wherein the method for calculating the sample size of the bridging design strategy is determined according to the basic elements of the clinical trial design scheme, comprises:

[0015] According to the basic elements of the clinical trial design plan, determine the basic elements of sample size calculation for the bridging design strategy;

[0016] According to the basic elements of sample size calculation of the bridging design strategy, a sample size calculation method of the bridging design strategy is determined.

[0017] Furthermore, in the method described above, the bridging trial data includes population data, intervention data, control group selection data, response variable data, statistical analysis method data, bias reduction method data, research purpose data, research type data, data source data and bridging design calculation algorithm data.

[0018] Furthermore, in the above method, the laws and regulations include the laws, regulations and guidelines issued by the U.S. Food and Drug Administration and / or the National Drug Administration.

[0019] Furthermore, in the method described above, the basic elements of the clinical trial design plan include innovations in basic research and drug action mechanisms, precision treatment, dynamic changes in treatment needs, improvements in drug safety, improvements in treatment experience and convenience, and patient needs.

[0020] Furthermore, the method described above, wherein determining the basic elements of the clinical trial design according to the bridging trial data and laws and regulations, includes:

[0021] Set up the project environment, project information, storage locations of various files, and test data reading cycles;

[0022] Determine the basic elements of the clinical trial design plan based on the bridging trial data and laws and regulations.

[0023] In a second aspect, the present application provides a system for generating a clinical trial design scheme based on a bridging design, including an electronic data acquisition system, a data storage module, a calculation method selection module, a data integration module, and a scheme generation module;

[0024] The electronic data acquisition system is used to obtain bridging trial data and determine the basic elements of the clinical trial design plan based on laws and regulations and the bridging trial data;

[0025] The data storage module is used to store the basic elements of the clinical trial design plan;

[0026] The calculation method selection module is used to retrieve and determine the sample size calculation method of the bridge design strategy according to the basic elements of the clinical trial design plan;

[0027] The data integration module is used to calculate the bridging test data according to the bridging design strategy sample size calculation method to obtain the bridging design strategy sample size calculation result;

[0028] The scheme generation module is used to generate a clinical trial design scheme based on the basic elements of the clinical trial design scheme and the sample size calculation result of the bridging design strategy.

[0029] Further, in the above-mentioned system, the electronic data collection system includes a project setting subsystem;

[0030] The project setting subsystem is used to set the project environment, project information, storage locations of various files and test data reading cycle of the electronic data acquisition system.

[0031] In a third aspect, the present application provides a device for generating a clinical trial design scheme based on a bridging design, including a processor, a memory, an input interface, an output interface, and a network interface:

[0032] Wherein, the processor is used to call and execute the program stored in the memory;

[0033] The memory is used to store the program, and the program is at least used to execute any one of the above methods for generating a clinical trial design;

[0034] The input interface is used to connect to an external input device for an administrator and / or user to input information data and perform maintenance on the device;

[0035] The output interface is used to connect to an external output device to display the program running result and / or program running process;

[0036] The network interface is used to connect to external user equipment and is used for external users to control the clinical trial design scheme generating device via the network.

[0037] The technical solution provided by this application may have the following beneficial effects:

[0038] In the technical solution provided by the present application, the data in the bridging test is first obtained, the basic elements of the clinical trial design scheme are determined, the sample size calculation method of the bridging design strategy is determined, and the bridging test data is calculated according to the sample size calculation method of the bridging design strategy to obtain the sample size calculation result of the bridging design strategy. Finally, the clinical trial design scheme is generated according to the basic elements of the clinical trial design scheme and the sample size calculation result of the bridging design strategy. In this way, by obtaining the bridging test data and calculating the bridging test data according to the sample size calculation method to formulate the clinical trial design scheme, the clinical trial design scheme can be automatically generated, and the clinical trial design scheme is more comprehensive, which improves the success rate of clinical trials and the success rate of drug development. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0040] Figure 1 It is a flow chart provided by an embodiment of a method for generating a clinical trial design scheme based on a bridging design of the present invention;

[0041] Figure 2 It is a structural schematic diagram provided by an embodiment of a system for generating a clinical trial design scheme based on a bridging design according to the present invention;

[0042] Figure 3 It is a structural schematic diagram provided by an embodiment of a device for generating a clinical trial design scheme based on a bridging design according to the present invention. DETAILED DESCRIPTION

[0043] To make the purpose, technical solution and advantages of the present invention clearer, the technical solution of the present invention will be described in detail below. Obviously, the described embodiments are only part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other implementation methods obtained by ordinary technicians in this field without creative work belong to the scope of protection of the present invention.

[0044] Currently, in the entire clinical trial industry, the generation of clinical trial design plans based on the data from bridging trials is done manually. Insufficient clinical trial design plans lead to the failure of clinical trials, reduced efficiency of clinical trials, and ultimately the failure of new drug development.

[0045] In order to solve the above problems, the purpose of the present invention is to provide a method, system and equipment for formulating a clinical trial design plan, so as to overcome the problem that the current clinical trial design plan is manually generated based on the data of the bridging trial, the design plan of the clinical trial is insufficient, resulting in the failure of the clinical trial, the reduction of the efficiency of the clinical trial, and ultimately the failure of the new drug development.

[0046] Reference Figure 1 , Figure 1 A flowchart is provided for an embodiment of a method for generating a clinical trial design scheme based on a bridging design in the present application, the method comprising at least the following steps:

[0047] S11. Obtain bridge test data.

[0048] In order to make the clinical trial design more clear and increase the value of the clinical trial design, it is necessary to first obtain bridging trial data. The bridging trial data includes population data, intervention data, control group selection data, response variable data, statistical analysis method data, bias reduction method data, research purpose data, research type data, data source data and bridging design calculation algorithm data.

[0049] S12. Determine the basic elements of the clinical trial design based on the bridging trial data and laws and regulations.

[0050] In order to make the calculation results of the bridging test data high-quality, complete and accurate, specifically, before calculating the bridging test data, the basic elements of the clinical trial design are formulated according to the bridging test data and laws and regulations; wherein the basic elements of the formulated clinical trial design include innovations in basic research and drug action mechanisms, precision treatment points, dynamic changes in treatment needs, drug safety improvements, treatment experience and convenience improvements, and patient needs. In some optional embodiments, the laws and regulations include laws, regulations and guidelines issued by the U.S. Food and Drug Administration and / or the National Drug Administration.

[0051] S13. Determine the sample size calculation method for the bridging design strategy based on the basic elements of the clinical trial design plan.

[0052] In order to make the calculation results high-quality, complete and accurate, specifically, the basic elements of sample size calculation for the bridging design strategy are determined based on the basic elements of the clinical trial design plan; the sample size calculation method for the bridging design strategy is determined based on the basic elements of sample size calculation for the bridging design strategy.

[0053] S14. Calculate the bridging test data according to the sample size calculation method of the bridging design strategy to obtain the sample size calculation result of the bridging design strategy.

[0054] S15. Generate a clinical trial design plan based on the basic elements of the clinical trial design plan and the sample size calculation results of the bridging design strategy.

[0055] Specifically, based on professional experience, domestic and international industry regulations, we integrate the sample size calculation results of the bridging design strategy and the basic elements of the clinical trial design plan to produce a high-quality, complete, accurate and error-free clinical trial design plan to guide the design, execution, analysis, reporting and interpretation of clinical trials, and ensure the accurate and efficient completion of the design, execution, analysis, reporting and interpretation of clinical trials.

[0056] By obtaining bridging trial data and calculating the bridging trial data according to the bridging design strategy sample size calculation method, a clinical trial design plan can be formulated. The clinical trial design plan can be automatically generated, and the clinical trial design plan is more comprehensive, which improves the success rate of clinical trials and the success rate of drug development, shortens the time of clinical trial development and reduces the cost of clinical trials.

[0057] In some optional embodiments, the bridging design calculation algorithm includes a bridging sample size calculation algorithm for a normally distributed endpoint, a binary endpoint, and a survival endpoint.

[0058] The calculation process of the normal distribution endpoint is as follows:

[0059] Assume that the treatment effect of the multiregional trial on the entire group is D all , the treatment effect on patients in a certain country is D S Then the sample size of patients from a certain country in the trial should meet the following requirements:

[0060] Pr(D s / D an >π)≥1-β′ (1)

[0061] where π is 0.5 or greater and 1-β′ is 0.8 or greater. That is, the sample size of patients in a certain country must ensure a probability of 1-β′ to prove that the treatment effect of patients in a certain country is greater than π times the overall treatment effect. The sample size calculation is performed at the design stage. If, at the design stage, it is strongly believed that the treatment effect for patients in a certain country and other patients will be very different due to the disease and the treatment under study, then (1) should not be used, and a separate trial may be conducted for patients in a certain country. Therefore, in the above sample size derivation in this article, we will assume that the treatment effect for patients in a certain country is similar or only slightly different from that for other patients at the design stage. Assume N S and N NS is the sample size of each treatment group in a certain country and non-certain country, δ S and δ NS For real therapeutic effect, and The corresponding estimated values ​​for patients in a certain country and those in non-certain countries, respectively; N = N S +N NS is the total sample size for each treatment group determined to ensure adequate overall power. is the estimate of the treatment effect for the whole group; the study endpoint follows a normal distribution with σ as the standard deviation. If the total sample size N is a two-sided test for significance level α and power 1-β, used to detect the total difference δ, then

[0062]

[0063] where z 1-ε is the percentage of (1-ε) of the standard normal distribution. Let f1(N S =f1N) is the corresponding minimum proportion of patients in a certain country.

[0064] Let δ J =δ NI =δ, the numerical solution of f1 can be obtained for given α, β, β' and π.

[0065]

[0066] Therefore, the sample size of each treatment group in a country is N S =f1N. For an unbalanced design, assume that the sample size of the placebo group is N and the sample size of the treatment group is kN. Then we only need to replace 2σ in formula (2) 2 Replace with (k+1 / k)σ 2 Used in all the above formulas for calculation. S After that, the sample size of patients in a certain country in the treatment group is abbreviated as kN S .

[0067] The calculation process of the binary endpoint is as follows:

[0068] The calculation process of the binary endpoint is similar to that of the normal endpoint. We only need to replace 2σ in formula (2) when calculating the total sample size N. 2 It is changed to p1(1-p1)+p0(1-p0), where p1 and p0 are the event rates of the treatment group and placebo group in the binary endpoint, respectively.

[0069] The calculation process of the survival endpoint is:

[0070] For survival endpoints, the following proportional hazards models are often considered:

[0071] II1λ1(t)=λ0(t)e γ

[0072] where λ1(t) is the hazard function for the treatment group, λ0(t) is the hazard function for the placebo group and e γ is the risk ratio between the treatment group and the placebo group. The power calculation is usually based on the Log-Rank test

[0073] T~N(μ,1) (13)

[0074] in

[0075] where E is the expected total number of events in the two groups. For a given significance level α (two-sided test) and power 1-β, the total number of events in the two groups is

[0076] In the following, two methods are used to derive the number of events required for patients in a country. In each delta method, three methods are considered: The first method is wE I / E, followed by w=0, and the third method is to Considered as a fixed constant γ all =γ.

[0077] [Delta Method 1]

[0078] w=E S / E:

[0079]

[0080] The number of events of patients in a certain country is recorded as E 1S =g1E, w=0:

[0081]

[0082] Will Considered as a fixed constant γ all =γ:

[0083] [Delta Method 2]

[0084] w=E I / E:

[0085] When w=0:

[0086] γ j =γ all =γ:

[0087] After the number of events is found, we convert the number of events into sample size, assuming that the event time and censoring time follow an exponential distribution. Two experimental designs are considered at the same time. One is a fixed termination time design, in which even if patients enter the study at staggered calendar times, once a certain total number of events is reached, they all stop treatment at the same calendar time. Such a design is usually used for relatively long survival trials. The other is a fixed study duration design, that is, all patients have the same fixed study duration regardless of when they enter the study.

[0088] λ0λ1

[0089] For a fixed termination time design, if the hazard rate for the placebo group is , for the drug group is , the common discontinuation hazard rate is τ (τ = 0 for the overall survival endpoint of the intention-to-treat set), the cumulative incidence rate in each time period is r. After the last randomization, A represents the cumulative time, F represents the follow-up time, and then the final L = A + F. The subject who enters the trial at time point s will have Pr (X i ≤min(Ls, C) probability of an event occurring when X i is the event time of treatment i and C is independent of X i Treatment discontinuation time due to:

[0090] The expected number of events in treatment group i is:

[0091]

[0092] Therefore, the total number of events in both queues is:

[0093] E=E0+E1=r(V0+V1)

[0094] The sample size of subjects in each cohort can then be derived as follows:

[0095] N=rA=AE / (V0+V1)

[0096] For a fixed treatment duration design, assume that the length of the study treatment duration for all subjects is L. Using the notation above, the overall total number of events from both cohorts is

[0097] E=E0+E1=N(H0(0)+H1(1))

[0098] The total number of samples for each cohort is:

[0099] N=E / (H0(0)+H1(1)).

[0100] The present invention also provides a system for generating a clinical trial design scheme based on a bridging design, which is used to implement the above method embodiment. Figure 2 1 is a schematic diagram of a structure provided by an embodiment of a system for generating a clinical trial design scheme based on a bridging design according to the present invention. Figure 2 As shown, a system for generating a clinical trial design scheme based on a bridging design comprises an electronic data acquisition system 1, a data storage module 2, a calculation method selection module 3, a data integration module 4 and a scheme generation module 5;

[0101] Electronic data collection system, used to obtain bridging trial data and determine the basic elements of clinical trial design according to laws and regulations and bridging trial data;

[0102] Data storage module, used to store basic elements of clinical trial design plan;

[0103] The calculation method selection module is used to retrieve and determine the sample size calculation method of the bridge design strategy based on the basic elements of the clinical trial design plan;

[0104] A data integration module is used to calculate the bridging test data according to the sample size calculation method of the bridging design strategy, and obtain the sample size calculation result of the bridging design strategy;

[0105] The scheme generation module is used to generate a clinical trial design scheme based on the basic elements of the clinical trial design scheme and the sample size calculation results of the bridging design strategy.

[0106] Further, in the clinical trial design scheme generation system provided in the present application, the electronic data acquisition system 1 includes a project setting subsystem;

[0107] The project setting subsystem is used to set the project environment, project information, storage locations of various files and test data reading cycle of the electronic data acquisition system.

[0108] Further, in the clinical trial design scheme generation system provided in the present application, the electronic data acquisition system 1 includes a clinical trial design scheme basic element target setting subsystem;

[0109] The clinical trial design plan basic elements target setting subsystem is used to collect the basic elements of the clinical trial design plan according to the laws and regulations issued by the U.S. Food and Drug Administration and the National Medical Products Administration.

[0110] Regarding the device in the above embodiment, the specific manner in which each module performs operations has been described in detail in the embodiment of the method, and will not be elaborated here.

[0111] In addition, if Figure 3As shown, based on the same inventive concept, the present application also discloses an electronic device 100, namely, a device for generating a clinical trial design scheme based on a bridging design, including a processor 101, a memory 102, an input interface 103, an output interface 104 and a network interface 105;

[0112] The processor 101 is a computing device that executes programs stored in the memory 102. The processor 101 implements various functions of the electronic device 100 by executing application programs;

[0113] The storage 102 includes a memory and a hard disk. The memory is a RAM which is a volatile storage element and temporarily stores the application program executed by the processor 101 and the data used when executing the application program.

[0114] The hard disk is a large-capacity and non-volatile storage device such as a mechanical hard disk (HDD) or a flash hard disk (SSD) for long-term storage of data used by the processor 101 when executing a program, and the program executed by the processor 101. That is, the program is read from the hard disk, loaded into the memory, and executed by the processor 101, thereby realizing various functions of the electronic device 100.

[0115] The input interface 103 is an interface to which input devices such as a keyboard and a mouse are connected and which receives input from an administrator. The output interface 104 is an interface to which a display is connected and which outputs results in a form that the administrator can view. The input interface 103 and the output interface 104 of the electronic device 100 are only used by the administrator to install and operate the application program of the electronic device 100. Other users use the input device and the output device provided by the terminal connected to the electronic device 100 via the network interface 105 to operate the system.

[0116] The application program executed by the processor 101 is provided to the electronic device 100 via a network and is stored in the hard disk of the memory 102 .

[0117] The electronic device 100 is a computer system constructed on one or more physical computers, and may also be executed on a virtual computer constructed on multiple physical computer resources.

[0118] It can be understood that the same or similar parts of the above embodiments can be referenced to each other, and the contents not described in detail in some embodiments can refer to the same or similar contents in other embodiments.

[0119] It should be noted that, in the description of the present invention, the terms "first", "second", etc. are only used for descriptive purposes and cannot be understood as indicating or implying relative importance. In addition, in the description of the present invention, unless otherwise specified, the meaning of "plurality" refers to at least two.

[0120] Any process or method description in a flowchart or otherwise described herein may be understood to represent a module, segment or portion of code that includes one or more executable instructions for implementing the steps of a specific logical function or process, and the scope of the preferred embodiments of the present invention includes alternative implementations in which functions may not be performed in the order shown or discussed, including performing functions in a substantially simultaneous manner or in the reverse order depending on the functions involved, which should be understood by those skilled in the art to which the embodiments of the present invention belong.

[0121] It should be understood that the various parts of the present invention can be implemented by hardware, software, firmware or a combination thereof. In the above-mentioned embodiments, a plurality of steps or methods can be implemented by software or firmware stored in a memory and executed by a suitable instruction execution system. For example, if implemented by hardware, as in another embodiment, it can be implemented by any one of the following technologies known in the art or their combination: a discrete logic circuit having a logic gate circuit for implementing a logic function for a data signal, a dedicated integrated circuit having a suitable combination of logic gate circuits, a programmable gate array (PGA), a field programmable gate array (FPGA), etc.

[0122] A person skilled in the art may understand that all or part of the steps in the method for implementing the above-mentioned embodiment may be completed by instructing related hardware through a program, and the program may be stored in a computer-readable storage medium, which, when executed, includes one or a combination of the steps of the method embodiment.

[0123] In addition, each functional unit in each embodiment of the present invention may be integrated into a processing module, or each unit may exist physically separately, or two or more units may be integrated into one module. The above-mentioned integrated module may be implemented in the form of hardware or in the form of a software functional module. If the integrated module is implemented in the form of a software functional module and sold or used as an independent product, it may also be stored in a computer-readable storage medium.

[0124] The storage medium mentioned above can be a read-only memory, a magnetic disk or an optical disk, etc.

[0125] In the description of this specification, the description with reference to the terms "one embodiment", "some embodiments", "examples", "specific examples", or "some examples" means that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic representation of the above terms does not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described may be combined in any one or more embodiments or examples in a suitable manner.

[0126] Although the embodiments of the present invention have been shown and described above, it is to be understood that the above embodiments are exemplary and are not to be construed as limitations of the present invention. A person skilled in the art may change, modify, replace and vary the above embodiments within the scope of the present invention.

Claims

1. A method for generating a clinical trial design based on a bridging design, characterized in that: include: Obtain bridge test data; Determine the basic elements of the clinical trial design plan based on the bridging trial data and laws and regulations; Determine the sample size calculation method for the bridging design strategy based on the basic elements of the clinical trial design plan; Calculate the bridging test data according to the bridging design strategy sample size calculation method to obtain a bridging design strategy sample size calculation result; Generate a clinical trial design plan based on the basic elements of the clinical trial design plan and the sample size calculation results of the bridging design strategy; Among them, the bridging trial data includes population data, intervention data, control group selection data, response variable data, statistical analysis method data, bias reduction method data, research purpose data, research type data, data source data and bridging design calculation algorithm data.

2. The method according to claim 1, characterized in that The method of calculating the sample size of the bridging design strategy according to the basic elements of the clinical trial design scheme includes: According to the basic elements of the clinical trial design plan, determine the basic elements of sample size calculation for the bridging design strategy; According to the basic elements of sample size calculation of the bridging design strategy, a sample size calculation method of the bridging design strategy is determined.

3. The method according to claim 1, characterized in that The laws and regulations include the laws, regulations and guidelines issued by the U.S. Food and Drug Administration and / or the National Drug Administration.

4. The method according to claim 1, characterized in that: The basic elements of the clinical trial design plan include innovations in basic research and drug action mechanisms, precision treatment, dynamic changes in treatment needs, improvements in drug safety, improvements in treatment experience and convenience, and patient needs.

5. The method according to claim 1, characterized in that According to the bridging trial data and laws and regulations, the basic elements of the clinical trial design are determined, including: Set up the project environment, project information, storage locations of various files, and test data reading cycles; Determine the basic elements of the clinical trial design plan based on the bridging trial data and laws and regulations.

6. A system for generating a clinical trial design based on a bridging design, characterized in that: It includes an electronic data acquisition system, a data storage module, a calculation method selection module, a data integration module and a solution generation module; The electronic data acquisition system is used to obtain bridging trial data and determine the basic elements of the clinical trial design plan based on laws and regulations and the bridging trial data; The data storage module is used to store the basic elements of the clinical trial design plan; The calculation method selection module is used to retrieve and determine the sample size calculation method of the bridge design strategy according to the basic elements of the clinical trial design plan; The data integration module is used to calculate the bridging test data according to the bridging design strategy sample size calculation method to obtain the bridging design strategy sample size calculation result; The scheme generation module is used to generate a clinical trial design scheme based on the basic elements of the clinical trial design scheme and the sample size calculation result of the bridging design strategy.

7. The system according to claim 6, characterized in that The electronic data collection system includes a project setting subsystem; The project setting subsystem is used to set the project environment, project information, storage locations of various files and test data reading cycle of the electronic data acquisition system.

8. A device for generating a clinical trial design based on a bridging design, characterized in that: Including processor, memory, input interface, output interface and network interface: Wherein, the processor is used to call and execute the program stored in the memory; The memory is used to store the program, and the program is at least used to execute the method for generating a clinical trial design scheme according to any one of claims 1 to 5; The input interface is used to connect to an external input device for an administrator and / or user to input information data and perform maintenance on the device; The output interface is used to connect to an external output device to display the program running result and / or program running process; The network interface is used to connect to external user equipment and is used for external users to control the clinical trial design scheme generating device via the network.

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