CN111383724A - Auxiliary system and method for random grouping of subjects in multi-center cooperative clinical trial - Google Patents
Auxiliary system and method for random grouping of subjects in multi-center cooperative clinical trial Download PDFInfo
- Publication number
- CN111383724A CN111383724A CN202010158216.6A CN202010158216A CN111383724A CN 111383724 A CN111383724 A CN 111383724A CN 202010158216 A CN202010158216 A CN 202010158216A CN 111383724 A CN111383724 A CN 111383724A
- Authority
- CN
- China
- Prior art keywords
- subject
- random number
- subjects
- grouping
- random
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 238000000034 method Methods 0.000 title claims abstract description 31
- 230000004044 response Effects 0.000 claims abstract description 18
- 238000012216 screening Methods 0.000 claims abstract description 11
- 238000004590 computer program Methods 0.000 claims description 10
- 201000010099 disease Diseases 0.000 claims description 9
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims description 9
- 230000002068 genetic effect Effects 0.000 claims description 6
- 238000012360 testing method Methods 0.000 abstract description 8
- 230000009286 beneficial effect Effects 0.000 abstract description 2
- 230000001737 promoting effect Effects 0.000 abstract description 2
- 238000011160 research Methods 0.000 description 6
- 238000004891 communication Methods 0.000 description 5
- 238000010586 diagram Methods 0.000 description 3
- 238000012545 processing Methods 0.000 description 3
- 230000002860 competitive effect Effects 0.000 description 2
- 238000013500 data storage Methods 0.000 description 1
- 230000005713 exacerbation Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000003058 natural language processing Methods 0.000 description 1
- 239000013307 optical fiber Substances 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 238000011269 treatment regimen Methods 0.000 description 1
Images
Classifications
-
- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
- G16H10/20—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for electronic clinical trials or questionnaires
Abstract
The invention discloses an auxiliary system and method for random grouping of testees in a multi-center cooperative clinical test. The assistance system includes: a correspondence generating unit configured to generate a correspondence of the random number and the group code; the screening unit is configured to respond to receiving a grouping application of a subject submitted by a research center end, extract relevant information of the subject from the grouping application and judge whether the subject meets grouping criteria or not based on the relevant information; a random number assigning unit configured to assign a random number to the subject among the random numbers in response to the subject satisfying the grouping criterion; and the group code recording unit is configured to obtain a group code corresponding to the random number distributed to the subject according to the corresponding relation between the random number and the group code, record the corresponding relation between the subject and the corresponding group code, and realize that the subject randomly enters the group. The scheme of the invention can balance the random group-entering time of the testees, and is beneficial to promoting the progress of clinical trials.
Description
Technical Field
The invention relates to the field of clinical research, in particular to an auxiliary system and a method for randomly grouping subjects in a multi-center cooperative clinical trial.
Background
In medical clinical trials, the conventional random group-entering method generally assigns random numbers to each research center in advance, and then assigns the random numbers to subjects independently from each research center so as to realize random group-entering. However, the prior art has at least the following problems that since the grouping progress of the whole medical clinical trial cannot be known and controlled in time, the grouping speed of each research center is different, and the research center with the relatively high grouping speed waits for the research center with the relatively low grouping speed to complete the research data of the subject responsible for the research center, and then can complete the whole medical clinical trial based on the research data. Therefore, the research center with slow group entering speed can influence the progress of the whole medical clinical test, and the scientific research period is prolonged.
Therefore, the above-mentioned situation that the overall progress of the clinical trial is affected by the random group entry speed difference becomes a technical problem which needs to be solved at present.
Disclosure of Invention
In order to solve the technical problem, the invention provides an auxiliary system and a method for randomly grouping subjects in a multi-center cooperative clinical trial.
As a first aspect of the present invention, there is provided an assistive system for randomized subject grouping in a multicenter-coordinated clinical trial, wherein the assistive system comprises:
a correspondence generating unit configured to generate a correspondence of the random number and the group code;
a screening unit configured to: in response to receiving a grouping application of a subject submitted by a research center terminal, extracting relevant information of the subject from the grouping application, judging whether the subject meets a grouping standard or not based on the relevant information, and in response to the subject not meeting the grouping standard, sending information not meeting the grouping standard to the research center terminal;
a random number assignment unit configured to: assigning a random number to the subject in the random number in response to the subject satisfying the grouping criteria;
a group code recording unit configured to: and obtaining a group code corresponding to the random number distributed to the subject according to the corresponding relation between the random number and the group code, and recording the corresponding relation between the subject and the corresponding group code to realize the random group entry of the subject.
In one embodiment, the correspondence generating unit is further configured to:
generating a random number table by using a preset random algorithm;
and establishing the corresponding relation between the random numbers and the group codes according to the corresponding relation between the random numbers and the corresponding position serial numbers in the random number table and the corresponding relation between the group codes and the corresponding position serial numbers in the group code table.
In one embodiment, the information that does not satisfy the grouping criteria includes items that do not satisfy the grouping criteria, and a rectification suggestion.
In one embodiment, the information related to the subject comprises: gender, age, race, genetic information, disease history.
In one embodiment, said determining whether said subject meets an entry criterion based on said correlation information comprises:
when the number of male subjects is greater than the number of female subjects in the already enrolled subjects, determining that male subjects subsequently applied for enrollment do not satisfy the enrollment criteria;
when the number of male subjects is less than the number of female subjects in the already enrolled subjects, then the female subjects subsequently applied for enrollment are determined not to satisfy the enrollment criteria.
As a second aspect of the present invention, a server is provided, wherein the server comprises the assistance system of the present invention.
As a third aspect of the present invention, there is provided a method for assisting random cohort of subjects in a multicenter-coordinated clinical trial, wherein the method comprises:
(1) generating a corresponding relation between the random number and the group code;
(2) in response to receiving a grouping application of a subject submitted by a research center terminal, extracting relevant information of the subject from the grouping application, judging whether the subject meets a grouping standard or not based on the relevant information, and in response to the subject not meeting the grouping standard, sending information not meeting the grouping standard to the research center terminal;
(3) assigning a random number to the subject in the random number in response to the subject satisfying the grouping criteria;
(4) and obtaining a group code corresponding to the random number distributed to the subject according to the corresponding relation between the random number and the group code, and recording the corresponding relation between the subject and the corresponding group code to realize the random group entry of the subject.
In one embodiment, in step (1), the generating a correspondence between the random number and the group code includes:
generating a random number table by using a preset random algorithm;
and establishing the corresponding relation between the random numbers and the group codes according to the corresponding relation between the random numbers and the corresponding position serial numbers in the random number table and the corresponding relation between the group codes and the corresponding position serial numbers in the group code table.
In one embodiment, in step (2), the information related to the subject includes: gender, age, race, genetic information, disease history.
In one embodiment, the information that does not satisfy the grouping criteria includes items that do not satisfy the grouping criteria, and a rectification suggestion.
In one embodiment, in step (2), said determining whether said subject satisfies the grouping criterion based on said correlation information comprises:
when the number of male subjects is greater than the number of female subjects in the already enrolled subjects, determining that male subjects subsequently applied for enrollment do not satisfy the enrollment criteria;
when the number of male subjects is less than the number of female subjects in the already enrolled subjects, then the female subjects subsequently applied for enrollment are determined not to satisfy the enrollment criteria.
As a fourth aspect of the present invention, there is provided a computer-readable storage medium having stored thereon a computer program which, when executed by a processor, implements the assistance method of the present invention.
By utilizing the auxiliary system, random grouping of the subjects in the multi-center cooperative clinical test can be realized, and competitive grouping can be formed among the subjects in different research centers, so that under the condition that the total number of the subjects in the whole clinical test is fixed, the research center with relatively high grouping speed can receive more subjects, and the research center with relatively low grouping speed can receive less subjects, thereby balancing the random grouping time of the subjects in the whole clinical test and being beneficial to promoting the overall progress of the clinical test.
Drawings
The invention will now be described by way of non-limiting example only with reference to the accompanying drawings, in which:
FIG. 1 is a schematic diagram illustrating an assistance system for randomized subject enrollment in a multicenter coordinated clinical trial, according to one embodiment of the invention;
FIG. 2 is a flow chart illustrating a method of assisting in randomized enrollment of subjects in a multicenter coordinated clinical trial according to one embodiment of the invention.
Detailed Description
In order to make the above and other features and advantages of the present invention more apparent, the present invention is further described below with reference to the accompanying drawings. It is understood that the specific embodiments described herein are for purposes of illustration only and are not intended to be limiting.
As a first aspect of the present invention, there is provided a system for assisting randomized subject enrollment in a multicenter-coordinated clinical trial. Figure 1 schematically illustrates an assistance system 100 for randomized enrollment of subjects in a multicenter coordinated clinical trial according to one embodiment of the invention. The assistance system 100 includes a correspondence generating unit 110, a screening unit 120, a random number assigning unit 130, and a group code recording unit 140, and each unit is communicatively coupled thereto. The assistance system 100 may be provided on a device for randomized subject grouping in a medical clinical trial, which may communicate with a plurality of study centers performing a coordinated clinical trial, wherein the device may be, for example, a server or other suitable intelligent terminal with data processing capabilities.
The correspondence generating unit 110 may be configured to generate a correspondence of the random number and the group code.
The correspondence generating unit 110 may generate a random number table by using a predetermined random algorithm, and then, establish a correspondence between the random number and the corresponding position number according to a correspondence between the random number and the corresponding position number in the random number table, and a correspondence between the random number and the corresponding position number in the group code table, in particular, when the auxiliary system 100 is initialized, a parameter of the random algorithm may be configured and a random seed may be input as an initial condition for execution of the random algorithm, wherein the random seed may be any applicable value, such as a current system time of the auxiliary system 100, the random algorithm may be any applicable random algorithm, such as a minimum random algorithm, the auxiliary system 100 may further include a dynamic interface reserved to facilitate subsequent updating of the random algorithm, the correspondence generating unit 110 may calculate a random number based on the random algorithm and the random seed to generate the random number table, if there are a plurality of applicable random algorithms, such as a minimum random algorithm, the auxiliary system 100 may further include a dynamic interface reserved to facilitate subsequent updating of the random algorithm, such as a random position number corresponding relationship between the random number and the random number in the random number table, such as a comparison between the random number and the random number corresponding position number table, such as a random number corresponding position number, and the random number corresponding position number in the random number table may be generated by comparing unit 110, and the random number table, such as a random number corresponding position number table, and the random number corresponding position number table may be represented by comparing unit 110, and the random number corresponding position number table, and may be represented by comparing unit 110, and may be represented by comparing unit 852, and may be represented by comparing unit, such as 852, and may be represented by comparing unit, and may be represented by a random number corresponding position number table, and may be represented by a random number corresponding position number table, and may be represented by a random number corresponding position number found by a random.
The screening unit 120 may be configured to, in response to receiving a enrollment application for a subject submitted by a study center, extract relevant information for the subject from the enrollment application, and determine whether the subject satisfies the enrollment criteria based on the relevant information, and in response to the subject not satisfying the enrollment criteria, send information not satisfying the enrollment criteria to the study center.
As can be appreciated, subjects prepared to participate in a clinical trial may be filed for enrollment applications at each study center through the study center side. The research center terminal may be in communication connection with the device for randomly grouping the subjects in the medical clinical trial through wireless communication, for example, through a mobile network, in which case, the research center terminal may be a mobile intelligent terminal or a handheld device equipped with the research center, for example, a tablet computer. Alternatively, the research center can be connected to the device for subject randomized inclusion in the medical clinical trial through wired communication, in which case, the research center can be a fixed intelligent device equipped in the research center, for example, a computer client with a touch-control display screen, which can be connected to the internet through a wired network optical fiber and communicate with the device for subject randomized inclusion in the medical clinical trial through the internet. In one example, the information that does not satisfy the grouping criteria includes items that do not satisfy the grouping criteria, and a rectification suggestion. The research center end receives the information which does not meet the grouping standard, then modifies the information and submits the information, the information which cannot be modified pays attention to the same problem when submitting the application next time, unqualified applications are not repeatedly submitted, and the workload is saved. In one example, there are a plurality of the research center terminals, and preferably, information that does not satisfy the grouping criteria is transmitted to the plurality of research center terminals.
Screening unit 120 may extract relevant information about the subject from the grouped application in a variety of ways. For example, the screening unit 120 may extract relevant information from the grouped applications using a predetermined algorithm, which may be a natural language processing algorithm, or other available algorithms, wherein the relevant information of the subject includes: gender, age, race, genetic information, disease history.
Depending on the circumstances, the screening unit 120 may determine whether the subject meets the grouping criteria in a variety of available ways. For example, the screening unit 120 may determine whether the subject satisfies the inclusion criterion based on the gender of the subject, and specifically, when the number of male subjects is greater than the number of female subjects in the already-included subjects, determine that male subjects subsequently applied for inclusion do not satisfy the inclusion criterion; when the number of male subjects is less than the number of female subjects in the already enrolled subjects, then the female subjects subsequently applied for enrollment are determined not to satisfy the enrollment criteria. Alternatively, the screening unit 120 may determine whether the subject meets the grouping criteria based on the age of the subject, and specifically, when the age of the subject is lower or higher than the legal age for participating in the clinical trial, the subject is not admitted to the group. Alternatively, the screening unit 120 may conclude whether the subject meets the inclusion criteria based on the subject's disease history, and in particular, not allow the subject to be included if the treatment regimen employed in the present clinical trial may lead to exacerbation or recurrence of other diseases in the subject's old disease that are not relevant to the present clinical trial.
The random number assigning unit 130 may be configured to assign a random number among the random numbers to the subject in response to the subject satisfying the grouping criterion. The group code recording unit 140 may be configured to obtain a group code corresponding to the random number allocated to the subject according to the corresponding relationship between the random number and the group code, record the corresponding relationship between the subject and the corresponding group code, and implement that the subject randomly enters into the group.
As can be appreciated, the random number assigning unit 130 may randomly select a random number from the random number table to assign a subject, while deleting the random number from the random number table. The group code recording unit 140 may search the group code table for a corresponding group code of the random number assigned to the subject based on the correspondence relationship, for example, the position number of the random number assigned to the subject is 3, and the group code recording unit 140 may search the group code table for a group code having the same position number of 3 as the group code corresponding to the random number assigned to the subject. The group code recording unit 140 can record the corresponding relationship between the subject and the corresponding group code in various ways, for example, it can be stored in a server or a database.
In addition, the auxiliary system 100 may determine whether the group code is transmitted to the research center according to the situation. For example, if the clinical trial is a double blind trial, the group code is not sent to the study center, so neither the investigator nor the subjects at the study center know the group of the subjects; or, if the clinical test is a single blind test, the group code is sent to the research center, but only the researcher has the right to view, i.e. uncover, so that only the subject does not know the group.
In conclusion, the auxiliary system is utilized to realize random grouping of the subjects in the multi-center collaborative clinical trial, so that competitive grouping can be formed among the subjects in different research centers, and therefore, under the condition that the total number of the subjects in the whole clinical trial is fixed, the research center with a relatively high grouping speed can receive a larger number of the subjects, and the research center with a relatively low grouping speed can receive a smaller number of the subjects, so that the random grouping time of the subjects in the whole clinical trial is balanced, and the overall progress of the clinical trial is facilitated to be promoted.
The assistance system for randomized subject enrollment in the multicenter collaborative clinical trial of the present invention as described above and the assistance method for randomized subject enrollment in the multicenter collaborative clinical trial of the present invention as described below may be applicable to a scenario where healthcare system workers are confronted with randomized subject enrollment in the multicenter collaborative clinical trial.
As a second aspect of the present invention, a server is provided, wherein the server comprises the assistance system of the present invention.
As a third aspect of the invention, there is provided a method of assisting in randomized enrollment of subjects into a group in a multicenter coordinated clinical trial. Figure 2 schematically illustrates a helper method 200 for randomized enrollment of subjects into groups in a multicenter coordinated clinical trial, according to one embodiment of the invention.
As shown in fig. 2, the assistance method 200 includes: s210, generating a corresponding relation between the random number and the group code; s220, in response to receiving a grouping application of a subject submitted by a research center terminal, extracting relevant information of the subject from the grouping application, judging whether the subject meets a grouping standard or not based on the relevant information, and in response to the fact that the subject does not meet the grouping standard, sending information which does not meet the grouping standard to the research center terminal; s230, responding to the fact that the subjects meet the grouping standard, and distributing a random number to the subjects in the random numbers; s240, obtaining a group code corresponding to the random number distributed to the subject according to the corresponding relation between the random number and the group code, and recording the corresponding relation between the subject and the corresponding group code to realize that the subject randomly enters the group.
In step S210, the generating a corresponding relationship between the random number and the group code includes: generating a random number table by using a preset random algorithm; and establishing the corresponding relation between the random numbers and the group codes according to the corresponding relation between the random numbers and the corresponding position serial numbers in the random number table and the corresponding relation between the group codes and the corresponding position serial numbers in the group code table.
In step S220, the relevant information of the subject includes: gender, age, race, genetic information, disease history.
In step S220, the information that does not satisfy the grouping criteria includes items that do not satisfy the grouping criteria, and the rectification advice.
In step S220, the determining whether the subject meets the grouping criterion based on the relevant information includes: when the number of male subjects is greater than the number of female subjects in the already enrolled subjects, determining that male subjects subsequently applied for enrollment do not satisfy the enrollment criteria; when the number of male subjects is less than the number of female subjects in the already enrolled subjects, then the female subjects subsequently applied for enrollment are determined not to satisfy the enrollment criteria.
It will be appreciated that the specific features described herein in relation to the adjunct system for randomized inclusion of subjects in a multicenter coordinated clinical trial of the first aspect may similarly be applied to a similar extension of the adjunct method for randomized inclusion of subjects in a multicenter coordinated clinical trial of the third aspect. For the sake of simplicity, it is not described in detail.
It should be understood that the various elements of the assistance system 100 of the invention may be implemented in whole or in part by software, hardware, firmware or a combination thereof. The units may be embedded in a processor of the computer device in a hardware or firmware form or independent of the processor, or may be stored in a memory of the computer device in a software form for being called by the processor to execute operations of the units. Each of the units may be implemented as a separate component or module, or two or more units may be implemented as a single component or module.
It will be appreciated by those of ordinary skill in the art that the schematic diagram of the assistance system 100 shown in fig. 1 is merely an illustrative block diagram of a portion of the structure associated with aspects of the present invention and does not constitute a limitation of the computer device, processor or computer program embodying aspects of the present invention. A particular computer device, processor or computer program may include more or fewer components or modules than shown in the figures, or may combine or split certain components or modules, or may have a different arrangement of components or modules.
As a fourth aspect of the invention, a computer-readable storage medium is provided, having stored thereon a computer program which, when being executed by a processor, carries out the steps of the method of the third aspect of the invention. In one embodiment, the computer program is distributed across a plurality of computer devices or processors coupled by a network such that the computer program is stored, accessed, and executed by one or more computer devices or processors in a distributed fashion. A single method step/operation, or two or more method steps/operations, may be performed by a single computer device or processor or by two or more computer devices or processors. One or more method steps/operations may be performed by one or more computer devices or processors, and one or more other method steps/operations may be performed by one or more other computer devices or processors. One or more computer devices or processors may perform a single method step/operation, or perform two or more method steps/operations.
As a fifth aspect of the invention, a computer device is provided, comprising a memory and a processor, the memory having stored thereon computer instructions executable by the processor, the computer instructions, when executed by the processor, instructing the processor to perform the steps of the auxiliary method of the third aspect of the invention. The computer device may broadly be a server, or any other electronic device having the necessary computing and/or processing capabilities. In one embodiment, the computer device may include a processor, memory, a network interface, a communication interface, etc., connected by a system bus. The processor of the computer device may be used to provide the necessary computing, processing and/or control capabilities. The memory of the computer device may include non-volatile storage media and internal memory. An operating system, a computer program, and the like may be stored in or on the non-volatile storage medium. The internal memory may provide an environment for the operating system and the computer programs in the non-volatile storage medium to run. The network interface and the communication interface of the computer device may be used to connect and communicate with an external device through a network. Which when executed by a processor performs the steps of the method of the invention.
It will be understood by those skilled in the art that all or part of the steps of the assistance method of the present invention may be instructed to be performed by associated hardware such as a computer device or a processor through a computer program, which may be stored in a non-transitory computer-readable storage medium, and which when executed performs the steps of the assistance method of the present invention. Any reference herein to memory, storage, databases, or other media may include non-volatile and/or volatile memory, as appropriate. Examples of non-volatile memory include read-only memory (ROM), programmable ROM (prom), electrically programmable ROM (eprom), electrically erasable programmable ROM (eeprom), flash memory, magnetic tape, floppy disk, magneto-optical data storage device, hard disk, solid state disk, and the like. Examples of volatile memory include Random Access Memory (RAM), external cache memory, and the like.
The respective technical features described above may be arbitrarily combined. Although not all possible combinations of features are described, any combination of features should be considered to be covered by the present specification as long as there is no contradiction between such combinations.
While the present invention has been described in connection with the embodiments, it is to be understood by those skilled in the art that the foregoing description and drawings are merely illustrative and not restrictive of the broad invention, and that this invention not be limited to the disclosed embodiments. Various modifications and variations are possible without departing from the spirit of the invention.
Claims (10)
1. An adjunct system for randomized enrollment of subjects in a multicenter coordinated clinical trial, the adjunct system comprising:
a correspondence generating unit configured to generate a correspondence of the random number and the group code;
a screening unit configured to: in response to receiving a grouping application of a subject submitted by a research center terminal, extracting relevant information of the subject from the grouping application, judging whether the subject meets a grouping standard or not based on the relevant information, and in response to the subject not meeting the grouping standard, sending information not meeting the grouping standard to the research center terminal;
a random number assignment unit configured to: assigning a random number to the subject in the random number in response to the subject satisfying the grouping criteria;
a group code recording unit configured to: and obtaining a group code corresponding to the random number distributed to the subject according to the corresponding relation between the random number and the group code, and recording the corresponding relation between the subject and the corresponding group code to realize the random group entry of the subject.
2. The assistance system according to claim 1, wherein the correspondence relationship generation unit is further configured to:
generating a random number table by using a preset random algorithm;
and establishing the corresponding relation between the random numbers and the group codes according to the corresponding relation between the random numbers and the corresponding position serial numbers in the random number table and the corresponding relation between the group codes and the corresponding position serial numbers in the group code table.
3. The assistance system according to claim 1, wherein the information related to the subject comprises: gender, age, race, genetic information, disease history.
4. The assistance system according to claim 3, wherein said determining whether the subject satisfies an entry criterion based on the relevant information comprises:
when the number of male subjects is greater than the number of female subjects in the already enrolled subjects, determining that male subjects subsequently applied for enrollment do not satisfy the enrollment criteria;
when the number of male subjects is less than the number of female subjects in the already enrolled subjects, then the female subjects subsequently applied for enrollment are determined not to satisfy the enrollment criteria.
5. A server, characterized in that the server comprises the assistance system of any one of claims 1-4.
6. An adjunct method for randomized enrollment of subjects into a group in a multicenter coordinated clinical trial, the adjunct method comprising:
(1) generating a corresponding relation between the random number and the group code;
(2) in response to receiving a grouping application of a subject submitted by a research center terminal, extracting relevant information of the subject from the grouping application, judging whether the subject meets a grouping standard or not based on the relevant information, and in response to the subject not meeting the grouping standard, sending information not meeting the grouping standard to the research center terminal;
(3) assigning a random number to the subject in the random number in response to the subject satisfying the grouping criteria;
(4) and obtaining a group code corresponding to the random number distributed to the subject according to the corresponding relation between the random number and the group code, and recording the corresponding relation between the subject and the corresponding group code to realize the random group entry of the subject.
7. The assistance method according to claim 6, wherein in step (1), the generating of the correspondence between the random number and the group code includes:
generating a random number table by using a preset random algorithm;
and establishing the corresponding relation between the random numbers and the group codes according to the corresponding relation between the random numbers and the corresponding position serial numbers in the random number table and the corresponding relation between the group codes and the corresponding position serial numbers in the group code table.
8. The support method according to claim 6, wherein in step (2), the information related to the subject includes: gender, age, race, genetic information, disease history.
9. The assistance system according to claim 8, wherein in step (2), said determining whether the subject satisfies the group entry criterion based on the relevant information comprises:
when the number of male subjects is greater than the number of female subjects in the already enrolled subjects, determining that male subjects subsequently applied for enrollment do not satisfy the enrollment criteria;
when the number of male subjects is less than the number of female subjects in the already enrolled subjects, then the female subjects subsequently applied for enrollment are determined not to satisfy the enrollment criteria.
10. A computer-readable storage medium, on which a computer program is stored which, when being executed by a processor, carries out the assistance method of any one of claims 6 to 9.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010158216.6A CN111383724A (en) | 2020-03-09 | 2020-03-09 | Auxiliary system and method for random grouping of subjects in multi-center cooperative clinical trial |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202010158216.6A CN111383724A (en) | 2020-03-09 | 2020-03-09 | Auxiliary system and method for random grouping of subjects in multi-center cooperative clinical trial |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN111383724A true CN111383724A (en) | 2020-07-07 |
Family
ID=71218653
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202010158216.6A Pending CN111383724A (en) | 2020-03-09 | 2020-03-09 | Auxiliary system and method for random grouping of subjects in multi-center cooperative clinical trial |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN111383724A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113539400A (en) * | 2021-07-07 | 2021-10-22 | 康奥生物科技(天津)股份有限公司 | Subject big data management method and system and electronic equipment |
| WO2022120852A1 (en) * | 2020-12-10 | 2022-06-16 | 苏州景昱医疗器械有限公司 | Program controller, double-blind test system for interactive medical equipment, and test method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101520824A (en) * | 2009-03-06 | 2009-09-02 | 北京迪美斯科技发展有限公司 | Method, device and system for testees to randomly group in medical clinical test |
| CN101520822A (en) * | 2009-03-06 | 2009-09-02 | 北京迪美斯科技发展有限公司 | Central stochastic system applied to medical clinical test |
| US20200005906A1 (en) * | 2018-06-27 | 2020-01-02 | International Business Machines Corporation | Clinical trial searching and matching |
-
2020
- 2020-03-09 CN CN202010158216.6A patent/CN111383724A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101520824A (en) * | 2009-03-06 | 2009-09-02 | 北京迪美斯科技发展有限公司 | Method, device and system for testees to randomly group in medical clinical test |
| CN101520822A (en) * | 2009-03-06 | 2009-09-02 | 北京迪美斯科技发展有限公司 | Central stochastic system applied to medical clinical test |
| US20200005906A1 (en) * | 2018-06-27 | 2020-01-02 | International Business Machines Corporation | Clinical trial searching and matching |
Non-Patent Citations (1)
| Title |
|---|
| 蔡宏伟等: "最小随机化分组系统在多中心临床试验中的应用", 《中国新药杂志》 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2022120852A1 (en) * | 2020-12-10 | 2022-06-16 | 苏州景昱医疗器械有限公司 | Program controller, double-blind test system for interactive medical equipment, and test method thereof |
| CN113539400A (en) * | 2021-07-07 | 2021-10-22 | 康奥生物科技(天津)股份有限公司 | Subject big data management method and system and electronic equipment |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US10402039B2 (en) | Adaptive user interface using machine learning model | |
| CN108932974B (en) | Method, device, computer equipment and storage medium for allocating doctors for online inquiry | |
| US20160335404A1 (en) | System and method for processor workload reduction for healthcare action plan | |
| JP2016198197A (en) | Diagnosis support system and application program | |
| CN109887584A (en) | It changes the place of examination method, system and server, computer readable storage medium | |
| CN111383724A (en) | Auxiliary system and method for random grouping of subjects in multi-center cooperative clinical trial | |
| CN111009311A (en) | Medical resource recommendation method, device, medium and equipment | |
| US11133110B2 (en) | Systems and methods for assessing whether medical procedures should be approved | |
| CN109377388B (en) | Medical insurance application method, medical insurance application device, computer equipment and storage medium | |
| US11710572B2 (en) | Experience engine-method and apparatus of learning from similar patients | |
| CN111785385A (en) | Disease classification method, device, equipment and storage medium | |
| CN111696661A (en) | Patient clustering model construction method, patient clustering method and related equipment | |
| CN112447270A (en) | Medication recommendation method, device, equipment and storage medium | |
| EP3465416A1 (en) | Methods and systems for creating and managing a research study and deploying via mobile and web utilizing a research module | |
| CN109326352B (en) | Disease prediction method, device, terminal and storage medium | |
| CN112017788B (en) | Disease ordering method, device, equipment and medium based on reinforcement learning model | |
| CN113724899A (en) | Online inquiry method, device, equipment and medium based on artificial intelligence | |
| CN113744845A (en) | Medical image processing method, device, equipment and medium based on artificial intelligence | |
| CN113724883B (en) | Medical expense prediction method, medical expense prediction device, storage medium and computer equipment | |
| CN114255478A (en) | Pet distribution method, device, storage medium and electronic equipment | |
| CN110473636B (en) | Intelligent medical advice recommendation method and system based on deep learning | |
| CN108511033B (en) | Test questionnaire generation method and related device | |
| CN113421653A (en) | Medical information pushing method and device, storage medium and computer equipment | |
| CN112016979A (en) | User grouping method, device, equipment and computer readable storage medium | |
| KR101615287B1 (en) | Device for selecting disease regulating ubiquitin ligases and method for selecting disease regulating ubiquitin ligases using the same |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20200707 |
|
| RJ01 | Rejection of invention patent application after publication |