CN114334072A - Method, system and equipment for establishing clinical trial development plan database - Google Patents
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Abstract
The invention relates to the technical field of clinical tests, in particular to a method, a system and equipment for establishing a clinical test development plan database. The method for establishing the clinical test development plan database comprises the steps of firstly making basic elements of clinical test development plan clinical value points, then collecting metadata of the clinical value points according to the made basic elements and the requirements of quality management specifications of an evaluation report, finally obtaining the clinical value points of the clinical test development plan through integration of the metadata of the clinical value points, and establishing the clinical development plan database. Therefore, the clinical value point metadata in the clinical test development plan is obtained, and the clinical value point of the clinical test development plan is obtained by integrating the clinical value point metadata, so that a clinical development plan database is established, the research and development direction of the clinical development plan can be accurately positioned, the clinical test development time is shortened, and the clinical test development cost is reduced.
Description
Technical Field
The invention relates to the technical field of clinical tests, in particular to a method, a system and equipment for establishing a clinical test development plan database.
Background
Clinical trials, which refer to trials conducted on human subjects, are systematic trials intended to discover or verify the clinical medical, pharmacological and other pharmacodynamic effects and adverse reactions of a certain drug under test, or to test the absorption, distribution, metabolism and excretion of a drug to determine the efficacy and safety of the drug.
Good clinical trial planning and implementation results from the interest in established principles of clinical research, including the protection of study subjects' rights, safety and well-being, and scientific standards, such as: a definite predetermined objective of research is needed to solve major scientific problems; selecting a suitable subject having a disease, condition or molecular/gene profile under study; methods to minimize bias are used, such as: randomization, blinding or masking, and/or control scrambling; the endpoints are unambiguous and measurable, and the method of assessing these endpoints is accurate and can be performed with minimal reporting or measurement bias.
A drug development plan describes all aspects of the development activities of a product from a target product profile to an approved activity. The preparation of the plan is typically prospective and updated as the development process progresses and new information is acquired. The program typically includes a characterization of the formulation development, non-clinical studies needed to support product assessment in human clinical studies and to support product approval, clinical studies to support efficacy and safety data in the relevant patient population, studies in a particular population, regional considerations for product commercialization and post-approval studies.
Clinical trials are the most time-consuming and costly area in the development of new drugs, and the success or failure of a new drug development is therefore closely related to the success or failure of clinical trials.
At present, the whole clinical trial industry lacks a method for establishing a clinical trial development plan database, and the established clinical trial development plan database is insufficient, so that the research and development directions of clinical trial development plans are inaccurate, the development time of clinical trials is long, the cost of clinical trials is high, and the success rate of clinical trials and the success rate of drug development are reduced.
Disclosure of Invention
In view of the above, the present invention aims to provide a method, a system and a device for extracting clinical value points of a clinical trial development plan, so as to solve the problems in the prior art that the research and development direction of the clinical trial development plan is inaccurate, the development time of the clinical trial is long and the clinical trial cost is high due to the deficiency of an established clinical trial development plan database.
In order to achieve the purpose, the invention adopts the following technical scheme:
in a first aspect, the present application provides a method for establishing a clinical trial development plan database, including:
acquiring basic elements of clinical value points of a clinical test development plan;
collecting the clinical value point metadata according to the clinical value point basic elements of the clinical test development plan and the requirements of the quality management specifications of the evaluation report;
determining clinical value points of a clinical trial development plan according to the clinical value point metadata;
and establishing a clinical development plan database according to the clinical value points of the clinical test development plan.
Further, according to the method for extracting clinical value points of the clinical trial development plan, the requirements of the quality management specifications of the evaluation report include: international regulations promulgated by the drug registration technical consortium and/or the united states food and drug administration and/or the national drug administration.
Further, according to the method for extracting clinical value points of the clinical trial development plan, the basic elements of the clinical value points of the clinical trial development plan include a basic research and drug action mechanism creation point, a precise treatment point, a dynamic change point of treatment requirements, a drug safety improvement point, a treatment experience and convenience improvement point and a patient demand point.
Further, according to the method for extracting clinical value points of the clinical trial development plan, the clinical value point metadata comprises clinical trials of similar drugs and preclinical data of the drug.
Further, the method for extracting clinical value points of the clinical trial development plan as described above, wherein the collecting of the metadata of the clinical value points according to the basic elements of the clinical value points of the clinical trial development plan and the requirements of the quality management specifications of the review report includes:
setting project environment, project information, various file storage positions and test data reading periods;
and collecting the clinical value point metadata according to the clinical value point basic elements of the clinical test development plan and the requirements of the quality management specifications of the evaluation report.
In a second aspect, the present application provides a clinical trial development plan database establishment system, including an electronic data acquisition system, a data storage module, a data integration module, and a clinical development plan database;
the electronic data acquisition system formulates the clinical test development plan clinical value point basic elements and acquires the clinical value point metadata according to the clinical test development plan clinical value point basic elements and the requirements of the quality management specifications of the evaluation report;
the data storage module is used for storing the clinical value point metadata;
the data integration module is used for calling and integrating the clinical value point metadata to obtain clinical value points of a clinical test development plan;
the clinical development plan database is used for storing clinical value points of the clinical trial development plan.
Further, the above clinical trial development plan clinical value point extraction system, the electronic data acquisition system includes an acquisition target setting subsystem;
and the acquisition target setting subsystem is used for acquiring the metadata of the clinical value points according to laws and regulations issued by the International drug registration technology coordination Commission, the United states food and drug administration and the national drug administration.
Further, the clinical value point extraction system of the clinical trial development plan comprises an electronic data acquisition system and a data acquisition and setting subsystem, wherein the electronic data acquisition system comprises a data acquisition and setting subsystem;
and the acquisition setting subsystem is used for setting the project environment, the project information, the storage positions of various files and the test data reading period of the electronic data acquisition system.
In a third aspect, the present application provides a clinical trial development plan database building apparatus, comprising a processor, a memory, an input interface, an output interface, and a network interface:
the processor is used for calling and executing the program stored in the memory;
the memory for storing the program for executing the method of establishing the clinical trial development plan database according to any one of the above methods;
the input interface is used for connecting external input equipment and is used for an administrator and/or a user to input information data and maintain the equipment;
the output interface is used for connecting external output equipment and displaying the program running result and/or the program running process;
the network interface is used for connecting an external user device, and an external user is used for operating the clinical test development plan database establishing device through a network.
The technical scheme provided by the application can comprise the following beneficial effects:
according to the technical scheme, the clinical value point basic elements of the clinical test development plan are firstly formulated, then the clinical value point metadata are collected according to the formulated basic elements and the requirements of the quality management specifications of the review report, the clinical value point of the clinical test development plan is finally obtained through the integration of the clinical value point metadata, and a clinical development plan database is established. Therefore, the clinical value point metadata in the clinical test development plan is obtained, and the clinical value point of the clinical test development plan is obtained by integrating the clinical value point metadata, so that a clinical development plan database is established, the research and development direction of the clinical development plan can be accurately positioned, the clinical test development time is shortened, and the clinical test development cost is reduced.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the drawings without creative efforts.
FIG. 1 is a flow chart provided by an embodiment of a method for building a clinical trial development plan database according to the invention;
FIG. 2 is a schematic diagram of a structure provided by one embodiment of the clinical trial development plan database building system of the present invention;
fig. 3 is a schematic structural diagram provided by an embodiment of the clinical trial development plan database building device of the invention.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the technical solutions of the present invention will be described in detail below. It is to be understood that the described embodiments are merely exemplary of the invention, and not restrictive of the full scope of the invention. All other embodiments, which can be derived by a person skilled in the art from the examples given herein without any inventive step, are within the scope of the present invention.
At present, the whole clinical trial industry lacks a method for establishing a clinical trial development plan database, and the established clinical trial development plan database is insufficient, so that the research and development directions of clinical trial development plans are inaccurate, the development time of clinical trials is long, the cost of clinical trials is high, and the success rate of clinical trials and the success rate of drug development are reduced.
In order to solve the above problems, the present application provides a method, a system, and a device for establishing a clinical trial development plan database, so as to overcome the problems of inaccurate development direction of clinical trial development plans, long development time of clinical trials, and high cost of clinical trials due to the deficiency of the established clinical trial development plan database.
Examples
Referring to fig. 1, fig. 1 is a flowchart of a method for extracting clinical value points of a clinical trial development plan according to an embodiment of the present application, the method at least including the following steps:
and S11, acquiring basic elements of clinical value points of the clinical test development plan.
In order to ensure that the extracted clinical value points of the clinical test development plan are high in quality, complete and accurate, specifically, before the clinical value points of the clinical test development plan are extracted, the basic elements of the clinical value points of the clinical test development plan are formulated; the established clinical trial development plan clinical value point basic elements comprise basic research and drug action mechanism creation points, accurate treatment points, dynamic change points of treatment demands, drug safety improvement points, treatment experience and convenience improvement points and patient demand points.
And S12, acquiring the metadata of the clinical value points according to the basic elements of the clinical value points of the clinical test development plan and the requirements of the quality management specifications of the evaluation report.
Specifically, the relevant collection settings are set, in some optional embodiments, the collection settings include a project environment, project information, various file storage locations, and a test data reading period, and the project environment and the project information are set according to clinical test projects; establishing a clinical development plan clinical value point extraction flow chart according to the set acquisition setting and the clinical test development plan clinical value point basic elements, and according to the established clinical development plan clinical value point extraction flow chart and the requirement of the quality management specification of the examination and evaluation report, authorizing the metadata of the clinical value point, wherein the requirement of the quality management specification of the examination and evaluation report comprises the manufacture of international legal regulations issued by the drug registration technical coordination, the U.S. food and drug supervision and administration and the national drug supervision and management bureau; in some alternative embodiments, the clinical value point metadata includes, a homogeneous drug clinical trial and preclinical data for the drug; in some alternative embodiments, the clinical value point metadata includes variables and variable tags, and the variable tags are composed of character strings.
And S13, determining clinical value points of the clinical trial development plan according to the metadata of the clinical value points.
Specifically, according to practical experience, national and international regulations of the industry and a summarized '669' principle, six elements of clinical test design and nine elements of clinical test design are included. Six major processes of clinical trials include planning, design, execution, analysis, reporting and interpretation; the six major factors of clinical trial design include study population, intervention, control group, response variables, methods to reduce or assess bias and statistical analysis; the nine minor elements comprise research population, intervention, control group, response variable, method for reducing or evaluating bias, statistical analysis, research purpose, research type and data source, and the clinical value point metadata is integrated to obtain the clinical value point of the clinical test development plan.
And S14, establishing a clinical development plan database according to the clinical value points of the clinical test development plan.
Specifically, a clinical trial development plan clinical value point database structure description file is made according to a clinical trial development plan clinical value point extraction flow chart, a clinical trial development plan clinical value point database is generated according to the clinical trial development plan clinical value point database structure description file, and the clinical trial development plan clinical value points are stored in the clinical trial development plan clinical value point database.
The clinical value point metadata in the clinical trial development plan is obtained, and the clinical value points of the clinical trial development plan are obtained by integrating the clinical value point metadata, so that a clinical trial development plan database is established, the research and development direction of the clinical trial development plan can be accurately positioned, the clinical trial development time is shortened, and the clinical trial development cost is reduced.
The invention also provides a clinical test development plan clinical value point extraction system, which is used for realizing the method embodiment. FIG. 2 is a schematic structural diagram of a clinical value point extraction system for a clinical trial development plan according to an embodiment of the present invention. As shown in fig. 2, a clinical value point extraction system for clinical trial development plans comprises an electronic data acquisition system 1, a data storage module 2, a data integration module 3 and a clinical development plan database 4;
the electronic data acquisition system 1 is used for making a clinical test development plan clinical value point basic element according to the requirement of the quality management standard of the evaluation report, and acquiring clinical value point metadata according to the clinical test development plan clinical value point basic element;
the data storage module 2 is used for storing the clinical value point metadata;
the data integration module 3 is used for retrieving and integrating the clinical value point metadata to obtain clinical value points of the clinical test development plan;
and the clinical development plan database 4 is used for storing clinical value points of clinical test development plans.
Further, in the clinical value point extraction system of the clinical trial development plan provided by the application, the electronic data acquisition system 1 comprises an acquisition target setting subsystem;
and the collection target setting subsystem is used for collecting the clinical value point metadata according to the manufacture of laws and regulations issued by the International drug registration technology coordination society, the United states food and drug administration and the national drug administration.
Further, in the clinical value point extraction system of the clinical trial development plan provided by the application, the electronic data acquisition system 1 comprises an acquisition setting subsystem;
and the acquisition setting subsystem is used for setting the project environment, the project information, the storage positions of various files and the reading period of the test data of the electronic data acquisition system.
With regard to the apparatus in the above-described embodiment, the specific manner in which each module performs the operation has been described in detail in the embodiment related to the method, and will not be elaborated here.
In addition, as shown in fig. 3, based on the same inventive concept, the present application further discloses an electronic device 100, that is, a clinical trial development plan clinical value point extracting device, including a processor 101, a memory 102, an input interface 103, an output interface 104, and a network interface 105;
the processor 101 is an arithmetic device that executes a program stored in the memory 102. The processor 101 implements various functions of the electronic apparatus 100 by executing an application program;
the memory 102 includes a memory, which is a RAM of a volatile storage element, and a hard disk, and temporarily stores an application program executed by the processor 101 and data used when executing the application program.
The hard disk is a mechanical hard disk (HDD) or a flash hard disk (SSD) large capacity nonvolatile storage device for long-term storage of data used by the processor 101 when executing programs and programs executed by the processor 101. That is, the functions of the electronic apparatus 100 are realized by reading out the program from the hard disk, loading the program into the memory, and executing the program by the processor 101.
The input interface 103 is an interface to which an input device such as a keyboard or a mouse is connected and which receives an input from an administrator. The output interface 104 is an interface to which a display is connected and outputs the result in a form that can be viewed by the administrator. The input interface 103 and the output interface 104 of the electronic device 100 are only used for an administrator to install and operate and maintain applications of the electronic device 100. Other users operate the system using input and output devices provided by terminals connected to the electronic apparatus 100 via the network interface 105.
The application program executed by the processor 101 is supplied to the electronic apparatus 100 via a network and stored in the hard disk of the memory 102.
The electronic device 100 is a computer system configured on one physical computer or a plurality of physical computers, and may be run on a virtual computer constructed on a plurality of physical computer resources.
It is understood that the same or similar parts in the above embodiments may be mutually referred to, and the same or similar parts in other embodiments may be referred to for the content which is not described in detail in some embodiments.
It should be noted that the terms "first," "second," and the like in the description of the present invention are used for descriptive purposes only and are not to be construed as indicating or implying relative importance. Further, in the description of the present invention, the meaning of "a plurality" means at least two unless otherwise specified.
Any process or method descriptions in flow charts or otherwise described herein may be understood as representing modules, segments, or portions of code which include one or more executable instructions for implementing specific logical functions or steps of the process, and alternate implementations are included within the scope of the preferred embodiment of the present invention in which functions may be executed out of order from that shown or discussed, including substantially concurrently or in reverse order, depending on the functionality involved, as would be understood by those reasonably skilled in the art of the present invention.
It should be understood that portions of the present invention may be implemented in hardware, software, firmware, or a combination thereof. In the above embodiments, the various steps or methods may be implemented in software or firmware stored in memory and executed by a suitable instruction execution system. For example, if implemented in hardware, as in another embodiment, any one or combination of the following techniques, which are known in the art, may be used: a discrete logic circuit having a logic gate circuit for implementing a logic function on a data signal, an application specific integrated circuit having an appropriate combinational logic gate circuit, a Programmable Gate Array (PGA), a Field Programmable Gate Array (FPGA), or the like.
It will be understood by those skilled in the art that all or part of the steps carried by the method for implementing the above embodiments may be implemented by hardware related to instructions of a program, which may be stored in a computer readable storage medium, and when the program is executed, the program includes one or a combination of the steps of the method embodiments.
In addition, functional units in the embodiments of the present invention may be integrated into one processing module, or each unit may exist alone physically, or two or more units are integrated into one module. The integrated module can be realized in a hardware mode, and can also be realized in a software functional module mode. The integrated module, if implemented in the form of a software functional module and sold or used as a stand-alone product, may also be stored in a computer readable storage medium.
The storage medium mentioned above may be a read-only memory, a magnetic or optical disk, etc.
In the description herein, references to the description of the term "one embodiment," "some embodiments," "an example," "a specific example," or "some examples," etc., mean that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the invention. In this specification, the schematic representations of the terms used above do not necessarily refer to the same embodiment or example. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.
Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention, and that variations, modifications, substitutions and alterations can be made to the above embodiments by those of ordinary skill in the art within the scope of the present invention.
Claims (9)
1. A method for establishing a clinical trial development plan database, comprising:
acquiring basic elements of clinical value points of a clinical test development plan;
collecting the clinical value point metadata according to the clinical value point basic elements of the clinical test development plan and the requirements of the quality management specifications of the evaluation report;
determining clinical value points of a clinical trial development plan according to the clinical value point metadata;
and establishing a clinical development plan database according to the clinical value points of the clinical test development plan.
2. The method of claim 1, wherein the requirements of the review report quality management specification comprise: international regulations promulgated by the drug registration technical consortium and/or the united states food and drug administration and/or the national drug administration.
3. The method of claim 1, wherein the clinical trial development plan clinical points of value essential elements include, basic research and drug mechanism of action innovation points, precision treatment points, dynamic change points of treatment needs, drug safety improvement points, treatment experience and convenience improvement points, and patient need points.
4. The method of claim 1, wherein the clinical value point metadata comprises a generic drug clinical trial and preclinical data of the drug.
5. The method of claim 1, wherein collecting clinical point of value metadata according to the clinical trial development plan clinical point of value base element and the requirements of the review report quality management specification comprises:
setting project environment, project information, various file storage positions and test data reading periods;
and collecting the clinical value point metadata according to the clinical value point basic elements of the clinical test development plan and the requirements of the quality management specifications of the evaluation report.
6. A clinical trial development plan database establishment system is characterized by comprising an electronic data acquisition system, a data storage module, a data integration module and a clinical development plan database;
the electronic data acquisition system is used for acquiring the clinical value point basic elements of the clinical test development plan and acquiring the clinical value point metadata according to the clinical value point basic elements of the clinical test development plan and the requirements of the quality management specifications of the evaluation report;
the data storage module is used for storing the clinical value point metadata;
the data integration module is used for calling and integrating the clinical value point metadata to obtain clinical value points of a clinical test development plan;
the clinical development plan database is used for storing clinical value points of the clinical trial development plan.
7. The clinical trial development plan database creation system of claim 6, wherein the electronic data collection system includes a collection goal setting subsystem;
the collection target setting subsystem is used for collecting the metadata of the clinical value points according to laws and regulations issued by the International Community for human drug registration technology and/or the United states food and drug administration and/or the national drug administration.
8. The clinical trial development plan database creation system of claim 6, wherein the electronic data collection system includes a collection setup subsystem;
and the acquisition setting subsystem is used for setting the project environment, the project information, the storage positions of various files and the test data reading period of the electronic data acquisition system.
9. A clinical trial development plan database building apparatus comprising a processor, a memory, an input interface, an output interface and a network interface:
the processor is used for calling and executing the program stored in the memory;
the memory for storing the program for performing at least the method of building the clinical trial development plan database according to any one of claims 1 to 5;
the input interface is used for connecting external input equipment and is used for an administrator and/or a user to input information data and maintain the equipment;
the output interface is used for connecting external output equipment and displaying the program running result and/or the program running process;
the network interface is used for connecting an external user device, and an external user is used for operating the clinical test development plan database establishing device through a network.
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