CN114049924A - Clinical trial development plan data point collection method and device and readable storage medium - Google Patents
Clinical trial development plan data point collection method and device and readable storage medium Download PDFInfo
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Abstract
The invention relates to a method, a device and a readable storage medium for collecting data points of a clinical trial development plan, wherein the method comprises the steps of acquiring basic element data for the clinical trial development plan; constructing a clinical trial development plan data point collection flow chart according to the basic element data; constructing a clinical trial development plan report table according to the clinical trial development plan data point collection flow chart; constructing a clinical trial development plan data point database structure description file according to a clinical trial development plan report table; and generating a clinical trial development plan data point database according to the clinical trial development plan data point database structure description file. The method and the device provide complete data points for developing clinical trial development plans, ensure more comprehensive functions of data collection of the clinical trial development plans, improve the success rate of clinical trials and the success rate of drug development, shorten the time of clinical trial development and reduce the cost of clinical trials.
Description
Technical Field
The invention belongs to the technical field of medical treatment, and particularly relates to a method and a device for collecting data points of a clinical trial development plan and a readable storage medium.
Background
Clinical trials, which refer to trials conducted on human subjects (patients or healthy subjects), are intended to find or verify clinical medical, pharmacological and other pharmacodynamic effects, adverse reactions, or absorption, distribution, metabolism and excretion of a test 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 necessary to support product evaluation 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 (e.g., pediatric population), regional considerations for product commercialization (e.g., health technology assessment) and post-approval studies.
In the related art, clinical trials are the place that takes the highest time and cost in the whole new drug development, so the success or failure of the development of a new drug is closely related to the success or failure of clinical trials. At present, a method for making a fully prepared clinical trial development plan is lacked in the whole clinical trial industry, so that the plan of clinical trials is insufficient, the failure of clinical trials is finally caused, the efficiency of clinical trials is reduced, and the failure of new drug development is finally caused, but how to acquire clinical trial development plan data points is still a difficult problem.
Disclosure of Invention
In view of the above, the present invention provides a method and an apparatus for collecting clinical trial development plan data points and a readable storage medium, so as to solve the problem that the prior art cannot collect clinical trial development plan data points.
In order to achieve the purpose, the invention adopts the following technical scheme: a clinical trial development plan data point collection method, comprising:
acquiring basic element data for a clinical trial development plan and preprocessing the basic element data; wherein the base element data comprises a plurality of data points;
constructing and storing a clinical trial development plan data point collection flow chart according to the preprocessed basic element data;
constructing and storing a clinical test development plan report table according to the clinical test development plan data point collection flow chart;
constructing and storing a clinical trial development plan data point database structure description file according to the clinical trial development plan report table;
and generating a clinical trial development plan data point database according to the clinical trial development plan data point database structure description file.
Further, the method also comprises the following steps:
data points in the clinical trial development plan data point database are integrated.
Further, the acquiring of the essential element data for the clinical trial development plan includes:
constructing a clinical trial development plan database;
docking a clinical trial development plan data source through a plurality of preset basic element data modules, and collecting basic element data; and/or fill in and gather the essential element data through personnel's editor;
and judging the attributes of the basic element data based on preset specifications, and inputting the data meeting the requirements into the database.
Further, the method also comprises the following steps:
the method comprises the steps of presetting a project environment, project information, a file storage position and a test data reading period of a clinical test, wherein the project environment and the project information are set according to a clinical test project.
Further, the preprocessing the basic element data includes:
and carrying out standardization processing on the basic element data to obtain standardized data.
Further, the basic element data includes:
clinical trial data of similar medicines and preclinical data of the medicine.
Further, the basic element data further includes:
the variable label is composed of character strings.
The embodiment of the application provides a clinical trial development plan data point collection device, includes:
the data acquisition module is used for acquiring basic element data for a clinical trial development plan; wherein the base element data comprises a plurality of data points;
the first construction module is used for constructing and storing a clinical trial development plan data point collection flow chart according to the basic element data;
the second construction module is used for constructing and storing a clinical test development plan report table according to the clinical test development plan data point collection flow chart;
the third construction module is used for constructing and storing a clinical trial development plan data point database structure description file according to the clinical trial development plan report table;
and the generation module is used for generating a clinical trial development plan data point database according to the clinical trial development plan data point database structure description file.
The embodiment of the present application provides a clinical trial development plan data point collecting device, including: the device comprises a processor, a memory, an input interface and an output interface;
the memory is used for storing a program at least for implementing the clinical trial development plan data point collection method provided by any of the above embodiments;
the processor is used for calling and executing the program stored in the memory;
the input interface is used for connecting an external input device and is used for an administrator and/or a user to input information data and maintain the clinical test development plan data point collecting device;
the output interface is used for connecting an external output device and displaying the program operation result and/or the program operation process.
The present application provides a computer readable storage medium having stored thereon executable instructions that, when executed by a processor, cause the processor to implement a method provided by any of the above embodiments.
By adopting the technical scheme, the invention can achieve the following beneficial effects:
the invention provides a method, a device and a readable storage medium for collecting clinical trial development plan data points, which solve the problem of collecting clinical trial development plan data points, formulate basic elements of a clinical trial development plan through an electronic data collection system, formulate a clinical trial development plan data point collection flow chart, formulate a clinical trial development plan report table, formulate a structure description file of a clinical trial development plan data point database, generate a clinical trial development plan data point database, provide complete data points for developing the clinical trial development plan, ensure more comprehensive functions of collecting the clinical trial development plan data, improve the success rate of clinical trials and the success rate of drug development, shorten the time of clinical trial development and reduce the cost of clinical trials.
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 schematic illustration of the steps of a clinical trial development plan data point collection method of the present invention;
FIG. 2 is a schematic flow chart of the data point collecting device for clinical trial development plans according to the present invention;
FIG. 3 is a schematic diagram of the clinical trial development plan data point collection electronics of the present 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.
In order to design a more comprehensive clinical test development strategy, the method summarizes the classic cases of clinical tests and combines self practices based on domestic and foreign regulations to summarize the '669' principle of clinical tests, namely six clinical test processes, six clinical test design elements and nine clinical test design elements. Six major processes of clinical trials include planning (Plan), Design (Design), execution (product), Analysis (Analysis), reporting (Report), and interpretation (interpretation); the six major elements of clinical trial design include Study Population (Study position), Intervention (Intervention), Control Group (Control Group), Response Variables (Response Variables), Methods to Reduce or Assess Bias (Methods to Reduce or Assesses) and Statistical Analysis (Statistical Analysis); nine minor elements include Study Population (Study position), Intervention (Intervention), Control Group (Control Group), Response Variables (Response Variables), Methods to Reduce or Assess Bias (Methods to Reduce or Assess Bias), Statistical Analysis (Statistical Analysis), Study Objectives (Study objects), Study Type (Study Type) and Data Sources (Data Sources). By defining the six clinical test processes, the six clinical test design factors and the nine clinical test design factors, the bias in the clinical test design can be greatly reduced.
A specific method, apparatus and readable storage medium for collecting data points of a clinical trial development plan provided in an embodiment of the present application will be described with reference to the accompanying drawings.
As shown in fig. 1, a method for collecting data points of a clinical trial development plan provided in an embodiment of the present application includes:
s1, acquiring basic element data for a clinical trial development plan and preprocessing the basic element data; wherein the base element data comprises a plurality of data points;
preferably, the preprocessing the basic element data includes:
and carrying out standardization processing on the basic element data to obtain standardized data.
It is to be understood that the standardization of the basic element data in the present application is determined based on the aforementioned "669" principle and relevant laws and regulations such as international harmonization of human drug registration technology, standards of the U.S. food and drug administration, standards of the national drug administration, and the like as guidelines and execution standards. In practical application, the collection of the basic element data can be performed through a preset electronic data collection system, the electronic data collection system can comprise a plurality of basic element data modules of a clinical trial development plan, and each module can realize the collection of the basic element data through the data collection system related to all clinical trials of related data in the clinical trial development plan or through editing and filling of personnel.
In particular, the collected base element data includes general considerations; dose and clinical pharmacology; evaluating the dose effect; control, truth criteria and compliance; randomization and blinding; a subject population and a special population; a statistical analysis plan; the quality management of clinical trials is standard; adverse drug experiences and reports; speeding up drug development planning, etc. The above is merely an exemplary description of the diversity of the data to be collected during the process of making the clinical trial development plan basic elements, so as to show that the data collection during the process of making the clinical trial development plan basic elements has strict standard requirements and standardization contents, and reference is mainly made to relevant laws and regulations issued by international human drug registration technical coordination, the U.S. food and drug administration, the national drug administration and the like as guiding principles and execution standards. The data associated with the clinical trial development plan data points collected by the various modules described above is aggregated to generate a clinical trial development plan data point database.
S2, constructing and storing a clinical trial development plan data point collection flow chart according to the preprocessed basic element data;
the clinical trial development plan data point collection flow chart comprises a data collection table, data points and the like, wherein the data collection table comprises the data with physicochemical properties enough to support the corresponding development stage, and animal research provides enough safety support and the like; wherein data points for which the pharmaco-physicochemical properties are sufficient to support the respective development phase include: drug purity, drug efficacy, drug stability, sterility of the drug; data points for animal studies that provide adequate safety support include: animal species correlations as a basis for dose selection, potentially toxic target organs, means to monitor potential toxicity, efficacy in animal models, suitability of animal models, etc.
TABLE 1 clinical trial development plan data points Collection Table
| Data collection table | Data points | Pre-IND/IND | Phase I clinical trial | EOP2 | Controlled clinical trial protocol |
| The physicochemical properties of the drug are sufficient to support the corresponding development phase | × | × | × | ||
| Purity of the drug | |||||
| Drug efficacy | |||||
| Stability of the drug | |||||
| Sterility of the drug (if applicable) | |||||
| Animal studies provide adequate safety support | × | × | |||
| Animal species correlation as a basis for dose selection | |||||
| Potentially toxic target organs | |||||
| Means for monitoring potential toxicity | |||||
| Whether effective in animal models | |||||
| Whether the animal model is suitable for |
As shown in table 1.
S3, constructing and storing a clinical test development plan report table according to the clinical test development plan data point collection flow chart;
the clinical trial development plan report table includes that the physicochemical property of the drug is enough to support the corresponding development stage, the animal research provides enough safety support, a human body Pharmacokinetic (PK) test plan and a human body Pharmaceutical (PD) test plan, and certainly can also include other test plans, which are not described herein any more; wherein, the physicochemical properties of the medicine are enough to support the corresponding development stages, including the purity, the efficacy, the stability and the sterility of the medicine; animal studies provide adequate safety support including animal species relevance as the basis for dose selection, potentially toxic target organs, means to monitor potential toxicity, efficacy in animal models, and suitability of animal models; human Pharmacokinetic (PK) test plans include dosing duration, dosing dose, dosing schedule, route of administration, and PK assessments; human Pharmaceutical (PD) test plans include duration of administration, dose of administration, dosing schedule, route of administration, and PD assessment.
Table 2 (a) pharmaco-physicochemical properties sufficient to support the respective development phases
| Purity of the drug | |
| Drug efficacy | |
| Stability of the drug | |
| Sterility of the drug | (if applicable) |
As shown in table 2 (a).
Table 2 (b) animal studies provide adequate safety support
| Animal species correlation as a basis for dose selection | |
| Potentially toxic target organs | |
| Means for monitoring potential toxicity | |
| Whether effective in animal models | |
| Whether the animal model is suitable for |
As shown in table 2 (b).
TABLE 2(c) human Pharmacokinetic (PK) test plan
| Duration of administration | |
| Dosage to be administered | |
| Time of administration | |
| Route of administration | |
| PK assessment |
As shown in table 2 (c).
TABLE 2 (d) human Pharmacodynamic (PD) test plan
| Duration of administration | |
| Dosage to be administered | |
| Time of administration | |
| Route of administration | |
| Evaluation of PD |
As shown in table 2 (d).
S4, constructing and storing a clinical trial development plan data point database structure description file according to the clinical trial development plan report table;
the clinical trial development plan data point database structure specification file includes tables, table names, variables, variable names, and variable types.
TABLE 3 clinical development plan data points database Structure description File
| Watch (A) | Table name | Variables of | Variable names | Variable type |
| cdprf | Clinical development plan report form | resthpro | Research products | Character(s) |
| cdprf | Clinical development plan report form | adapdis | Indications of | Character(s) |
| ppd | The physicochemical properties of the drug are sufficient to support the corresponding development phase | purotdru | Purity of the drug | Character(s) |
| ppd | The physicochemical properties of the drug are sufficient to support the corresponding development phase | efficacy | Drug efficacy | Character(s) |
| ppd | The physicochemical properties of the drug are sufficient to support the corresponding development phase | stabi | Stability of the drug | Character(s) |
| ppd | The physicochemical properties of the drug are sufficient to support the corresponding development phase | steri | Sterility of the drug | Character(s) |
| ans | Animal studies provide adequate safety support | anirele | Animal species correlation as a basis for dose selection | Character(s) |
| ans | Animal studies provide adequate safety support | ptotaror | Potentially toxic target organs | Character(s) |
| ans | Animal studies provide adequate safety support | mopto | Means for monitoring potential toxicity | Character(s) |
As shown in table 3.
And S5, generating a clinical trial development plan data point database according to the clinical trial development plan data point database structure description file.
The working principle of the clinical trial development plan data point collection method is as follows: firstly, acquiring basic element data for a clinical trial development plan and preprocessing the basic element data; wherein the base element data comprises a plurality of data points; constructing and storing a clinical trial development plan data point collection flow chart according to the preprocessed basic element data; constructing and storing a clinical test development plan report table according to the clinical test development plan data point collection flow chart; constructing and storing a clinical trial development plan data point database structure description file according to the clinical trial development plan report table; and generating a clinical trial development plan data point database according to the clinical trial development plan data point database structure description file.
The clinical trial development plan data point collection method provided by the application further comprises the following steps:
data points in the clinical trial development plan data point database are integrated.
Specifically, the clinical trial development data points with high quality, completeness, accuracy and no errors are obtained by collecting the clinical trial development data point data and integrating the clinical trial development data points, so that the design, execution, analysis, report and explanation of the clinical trial are guided, and the design, execution, analysis, report and explanation of the clinical trial are accurately and efficiently completed.
Preferably, the acquiring of the essential element data for clinical trial development planning includes:
constructing a clinical trial development plan database;
docking a clinical trial development plan data source through a plurality of preset basic element data modules, and collecting basic element data; and/or fill in and gather the essential element data through personnel's editor;
and judging the attributes of the basic element data based on preset specifications, and inputting the data meeting the requirements into the database.
Specifically, when acquiring basic element data, a clinical trial development plan database needs to be constructed in advance, and a plurality of preset basic element data modules are used for butting a clinical trial development plan data source to acquire the basic element data; or fill in and gather the essential element data through the editor of the personnel; and then, judging the attribute of the basic element data based on the requirements of the quality management specifications of the audit reports of the United states food and drug administration and the national drug administration, and inputting the data meeting the requirements into the database.
In some embodiments, further comprising:
the method comprises the steps of presetting a project environment, project information, a file storage position and a test data reading period of a clinical test, wherein the project environment and the project information are set according to a clinical test project.
Preferably, the basic element data includes:
clinical test of similar medicine and preclinical data of the medicine.
Preferably, the basic element data further includes:
the variable label is composed of character strings.
It is to be understood that the collected clinical trial development plan standard metadata contains variables and variable tags, and the variable tags are composed of character strings. The standardization process comprises screening the basic element data for variables and identifying the hierarchical relation among the variables; and then converting the basic element data into standard data based on the screening and identification results to obtain and store a standard data set of the clinical trial development plan. As shown in table 4, the variables may include, among others, primary variables, secondary variables, tertiary variables, etc. Wherein the primary variables may include a new drug pre-clinical trial application meeting/new drug clinical trial application original data submission, phase i clinical trial protocol, phase ii end meeting/phase iii planning, controlled clinical trial protocol review (including ad hoc protocol review), rapid channel and breakthrough therapy, new drug clinical trial application safety report (21 CFR 312.32 (c)). The secondary variable and the tertiary variable can be set according to actual needs, and are not described herein any more.
TABLE 4 Collection of clinical trial development plan Standard metadata containing variables and variable tags
| Whether or not to Is suitable for | Number of the watch | Table name | First-level transformation Number of measurement | First order variable | Two-stage transformation Number of measurement | Two-stage variable | Three-stage transformation Number of measurement | Three- |
| 1 | |
1 | New drug meeting before clinical trial application
Drug clinical trial application |
1 | |
1 | Purity of the |
|
| 1 | List 2 | 2 | Phase I |
3 | |
1 | |
|
| 1 | |
3 | End of phase II meeting/phase III planning | 3 | |
3 | |
|
| 1 | List 4 | 4 | Controlled clinical trial protocol review (including Ad hoc review). | 1 | Design of |
1 | Hypothesis of |
|
| 1 | List 5 | 5 | Rapid channel and breakthrough therapy. | 1 | Treating |
1 | Severe disease Property of (2) | |
| 1 | List 6 | 6 | Safety report of new drug clinical trial application (21 CFR 312.32(c)) | 3 | Medication information | 2 | Concomitant medication |
As shown in table 4.
As shown in fig. 2, an embodiment of the present application provides a clinical trial development plan data point collecting apparatus, including:
a data acquisition module 201 for acquiring basic element data for a clinical trial development plan; wherein the base element data comprises a plurality of data points;
a first construction module 202, configured to construct and store a clinical trial development plan data point collection flowchart according to the basic element data;
the second construction module 203 is used for constructing and storing a clinical test development plan report table according to the clinical test development plan data point collection flow chart;
a third constructing module 204, configured to construct and store a clinical trial development plan data point database structure description file according to the clinical trial development plan report table;
a generating module 205, configured to generate a clinical trial development plan data point database according to the clinical trial development plan data point database structure description file.
The working principle of the clinical trial development plan data point collecting device provided by the embodiment of the application is that the data acquisition module 201 acquires basic element data for a clinical trial development plan; wherein the base element data comprises a plurality of data points; the first construction module 202 constructs and stores a clinical trial development plan data point collection flow chart according to the basic element data; the second construction module 203 constructs and stores a clinical test development plan report table according to the clinical test development plan data point collection flow chart; the third construction module 504 constructs and stores a clinical trial development plan data point database structure description file according to the clinical trial development plan report table; the generation module 205 generates a clinical trial development plan data point database from the clinical trial development plan data point database structure specification file.
The clinical trial development plan data point collecting device provides complete data points for developing clinical trial development plans, ensures more comprehensive functions of collecting clinical trial development plan data points, 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.
Specifically, fig. 3 is a schematic structural diagram of a clinical trial development plan generation device provided in the embodiment of the present application;
the electronic device 100 of the present embodiment includes: a processor (CPU) 101, a memory 102, a hard disk 103, an input interface 104, an output interface 105, and a network interface 106.
The processor 101 is an arithmetic device that executes programs stored in the memory 102. The processor 101 implements various functions of the electronic device 100 by executing application programs.
The memory 102 is a RAM that is a volatile storage element and temporarily stores an application program executed by the processor 101 and data used when the application program is executed.
The hard disk 101 is a large-capacity nonvolatile storage device such as a mechanical hard disk (HDD) or a flash hard disk (SSD) for long-term storage of data (for example, the clinical trial development plan metadata 11 and the metadata description file 12 shown in table 3) 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 the program from the hard disk 103, loading the program into the memory 102, and executing the program by the processor 101.
The input interface 104 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 105 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 104 and the output interface 105 of the electronic device 100 are only used for an administrator to install and operate an application 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 106.
An application program executed by the processor 101 is supplied to the electronic apparatus 100 via a network and stored in the hard disk 103.
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.
Embodiments of the present application further provide a computer-readable storage medium on which a program product capable of implementing the above method in this specification is stored. In some possible embodiments, aspects of the invention may also be implemented in the form of a program product comprising program code means for causing a terminal device to carry out the steps according to various exemplary embodiments of the invention described in the above-mentioned "exemplary methods" section of the description, when said program product is run on the terminal.
A program product for implementing the above-described method for clinical trial development plan data point collection according to an embodiment of the present invention may employ a portable compact disc read only memory (CD-ROM) and include program code, and may be run on a terminal device, such as a personal computer. However, the program product of the present invention is not limited thereto, and in this document, a readable storage medium may be a tangible medium that can be recognized as containing or storing a program for use by or in connection with an instruction execution system, apparatus, or device.
The program product may employ any combination of one or more readable media. The readable medium may be a readable signal medium or a readable storage medium. A readable storage medium may be, for example, but not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any combination of the foregoing. More specific examples (a non-exhaustive list) of the readable storage medium include: an electrical connection having one or more wires, a portable disk, a hard disk, a Random Access Memory (RAM), a read-only memory (ROM), a pluggable programmable read-only memory (EPROM or flash memory), an optical fiber, a portable compact disc read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the foregoing.
In summary, the present invention provides a method, an apparatus and a readable storage medium for collecting data points of a clinical trial development plan, the method includes acquiring basic element data for the clinical trial development plan; constructing a clinical trial development plan data point collection flow chart according to the basic element data; constructing a clinical trial development plan report table according to the clinical trial development plan data point collection flow chart; constructing a clinical trial development plan data point database structure description file according to a clinical trial development plan report table; and generating a clinical trial development plan data point database according to the clinical trial development plan data point database structure description file. The method and the device provide complete data points for developing clinical trial development plans, ensure more comprehensive functions of data collection of the clinical trial development plans, improve the success rate of clinical trials and the success rate of drug development, shorten the time of clinical trial development and reduce the cost of clinical trials.
It is to be understood that the embodiments of the method provided above correspond to the embodiments of the apparatus described above, and the corresponding specific contents may be referred to each other, which is not described herein again.
As will be appreciated by one skilled in the art, embodiments of the present application may be provided as a method, system, or computer program product. Accordingly, the present application may take the form of an entirely hardware embodiment, an entirely software embodiment or an embodiment combining software and hardware aspects. Furthermore, the present application may take the form of a computer program product embodied on one or more computer-usable storage media (including, but not limited to, disk storage, optical storage, and the like) having computer-usable program code embodied therein.
The present application is described with reference to flowchart illustrations and/or block diagrams of methods, apparatus (systems), and computer program products according to embodiments of the application. It will be understood that each flow and/or block of the flow diagrams and/or block diagrams, and combinations of flows and/or blocks in the flow diagrams and/or block diagrams, can be implemented by computer program instructions. These computer program instructions may be provided to a processor of a general purpose computer, special purpose computer, embedded processor, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, create means for implementing the functions specified in the flowchart flow or flows and/or block diagram block or blocks.
These computer program instructions may also be stored in a computer-readable memory that can direct a computer or other programmable data processing apparatus to function in a particular manner, such that the instructions stored in the computer-readable memory produce an article of manufacture including instruction means which implement the function specified in the flowchart flow or flows and/or block diagram block or blocks.
These computer program instructions may also be loaded onto a computer or other programmable data processing apparatus to cause a series of operational steps to be performed on the computer or other programmable apparatus to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide steps for implementing the functions specified in the flowchart flow or flows and/or block diagram block or blocks.
The above description is only for the specific embodiments of the present invention, but the scope of the present invention is not limited thereto, and any person skilled in the art can easily conceive of the changes or substitutions within the technical scope of the present invention, and all the changes or substitutions should be covered within the scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the appended claims.
Claims (10)
1. A method of collecting data points for a clinical trial development plan, comprising:
acquiring basic element data for a clinical trial development plan and preprocessing the basic element data; wherein the base element data comprises a plurality of data points;
constructing and storing a clinical trial development plan data point collection flow chart according to the preprocessed basic element data;
constructing and storing a clinical test development plan report table according to the clinical test development plan data point collection flow chart;
constructing and storing a clinical trial development plan data point database structure description file according to the clinical trial development plan report table;
and generating a clinical trial development plan data point database according to the clinical trial development plan data point database structure description file.
2. The method of claim 1, further comprising:
data points in the clinical trial development plan data point database are integrated.
3. The method of claim 1, wherein said obtaining base element data for a clinical trial development plan comprises:
constructing a clinical trial development plan database;
docking a clinical trial development plan data source through a plurality of preset basic element data modules, and collecting basic element data; and/or fill in and gather the essential element data through personnel's editor;
and judging the attributes of the basic element data based on preset specifications, and inputting the data meeting the requirements into the database.
4. The method of claim 3, further comprising:
the method comprises the steps of presetting a project environment, project information, a file storage position and a test data reading period of a clinical test, wherein the project environment and the project information are set according to a clinical test project.
5. The method of claim 1, wherein preprocessing the base element data comprises:
and carrying out standardization processing on the basic element data to obtain standardized data.
6. The method of claim 1, wherein the base element data comprises:
clinical trial data of similar medicines and preclinical data of the medicine.
7. The method of claim 1, wherein the base element data further comprises:
the variable label is composed of character strings.
8. A clinical trial development plan data point collection apparatus, comprising:
the data acquisition module is used for acquiring basic element data for a clinical trial development plan; wherein the base element data comprises a plurality of data points;
the first construction module is used for constructing and storing a clinical trial development plan data point collection flow chart according to the basic element data;
the second construction module is used for constructing and storing a clinical test development plan report table according to the clinical test development plan data point collection flow chart;
the third construction module is used for constructing and storing a clinical trial development plan data point database structure description file according to the clinical trial development plan report table;
and the generation module is used for generating a clinical trial development plan data point database according to the clinical trial development plan data point database structure description file.
9. A clinical trial development plan data point collection apparatus, comprising: the device comprises a processor, a memory, an input interface and an output interface;
the memory for storing a program for implementing at least the clinical trial development plan data point collection method of any of claims 1-6;
the processor is used for calling and executing the program stored in the memory;
the input interface is used for connecting an external input device and is used for an administrator and/or a user to input information data and maintain the clinical test development plan data point collecting device;
the output interface is used for connecting an external output device and displaying the program operation result and/or the program operation process.
10. A computer-readable storage medium having stored thereon executable instructions which, when executed by a processor, cause the processor to carry out the method of any one of claims 1 to 7.
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| CN202210029120.9A CN114049924A (en) | 2022-01-12 | 2022-01-12 | Clinical trial development plan data point collection method and device and readable storage medium |
| PCT/CN2022/072455 WO2023133905A1 (en) | 2022-01-12 | 2022-01-18 | Clinical trial development plan data point collection method and device, and readable storage medium |
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