CN108597563A - Dynamic random group technology and system - Google Patents
Dynamic random group technology and system Download PDFInfo
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- CN108597563A CN108597563A CN201810386928.6A CN201810386928A CN108597563A CN 108597563 A CN108597563 A CN 108597563A CN 201810386928 A CN201810386928 A CN 201810386928A CN 108597563 A CN108597563 A CN 108597563A
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- 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
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- 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
- G16H10/40—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
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Abstract
The invention discloses a kind of dynamic random group technology and systems.Wherein, this method includes：Obtain the essential characteristic of target object, and distribution situation of the enrolled object between each group；According to the essential characteristic and the distribution situation, calculates the target object and be assigned to each group of total difference degree brought to system；The value of each total difference degree is ranked up, determines minimum value, and records the group where the minimum value；Judge whether the number of the group of the minimum value is unique；If the number of the group of the minimum value is unique, random number is taken out from preset random sequence, and according to the random number, distribute the target object；If the number of the group of the minimum value is not unique, a group is randomly selected in the group of the minimum value of identical total difference degree as target group, the target object is distributed to the target group.The present invention solves the technical issues of dynamic random group technology is without reproducibility.
Description
Technical field
The present invention relates to clinical researches to be grouped field at random, in particular to a kind of dynamic random group technology and is
System.
Background technology
Clinical Trials refer to the systematic Study of any drug carried out in human body (patient or healthy volunteer), with
Confirm or find effect, adverse reaction and/or absorption in terms of the clinic of trial drug, pharmacology and/or other pharmacodynamics, point
Cloth, metabolism and excretion, it is therefore an objective to determine safety and the validity of trial drug, be carried in listing for original new drug (or imitation medicine)
For foundation.
Randomized grouping is the important link in clinical test.Dynamic random group technology, wherein to minimize random point
Group method is representative, recently by the most attention of industry.It was issued in 2016 according to state food pharmaceuticals administration general bureau
's《The biostatistics guideline of clinical drug trial》, reproducibility should be had by being randomly assigned table.But not due to dynamic random
As district's groups are random, before on-test, one can not be generated and be randomly assigned table, the feature of patient itself and its is enrolled
Time sequencing can all influence the result of grouping.This is also that this method is hindered to be promoted and applied on a large scale in Clinical Trials
One of problem.
For above-mentioned problem, currently no effective solution has been proposed.
Invention content
An embodiment of the present invention provides a kind of dynamic random group technology and systems, at least to solve dynamic random grouping side
Method does not have the technical issues of reproducibility.
One side according to the ... of the embodiment of the present invention provides a kind of dynamic random group technology, including：Obtain target pair
The essential characteristic of elephant, and distribution situation of the enrolled object between each group；According to the essential characteristic and the distribution feelings
Condition calculates the target object and is assigned to each group of total difference degree brought to system；To the value of each total difference degree into
Row sequence, determines minimum value, and record the group where the minimum value；Judge whether the number of the group of the minimum value is unique；
If the number of the group of the minimum value is unique, random number is taken out from preset random sequence, and according to the random number, distribution
The target object；If the number of the group of the minimum value is not unique, in the group of the minimum value of identical total difference degree with
Machine extracts a group as target group, and the target object is distributed to the target group.
Optionally, described according to the random number, distributing the target object includes：Judge whether the random number is more than
Completely random is grouped probability；If the random number, which is more than the completely random, is grouped probability, the target object is distributed to mesh
Mark group, the target group are the group where the minimum value；If the random number, which is less than or equal to the completely random, is grouped probability,
Then the target object is distributed according to completely random group technology.
Optionally, when taking out the random number from the preset random sequence, by the row where the random number
It is marked, and the ID number of the target object of the random number will be used to be associated.
Optionally, the essential characteristic of the target object includes at least one of：Prognostic Factors, prognostic level.
Another aspect according to the ... of the embodiment of the present invention additionally provides a kind of dynamic random grouping system, including：It obtains single
Member, the essential characteristic for obtaining target object, and distribution situation of the enrolled object between each group；Computing unit is used
According to the essential characteristic and the distribution situation, calculates the target object and be assigned to each group of totality brought to system
Diversity factor；Processing unit is ranked up for the value to each total difference degree, determines minimum value, and records the minimum value
The group at place；Whether judging unit, the number for judging the group of the minimum value are unique；Allocation unit, if for it is described most
The number of the group of small value is unique, random number is taken out from preset random sequence, and according to the random number, distribute the target
Object；If the number of the group of the minimum value is not unique, one is randomly selected in the group of the minimum value of identical total difference degree
A group is used as target group, and the target object is distributed to the target group.
Optionally, the allocation unit distributes the target object for executing following steps according to the random number：Sentence
Whether the random number of breaking, which is more than completely random, is grouped probability；It, will if the random number, which is more than the completely random, is grouped probability
The target object is distributed to target group, and the target group is the group where the minimum value；If the random number is less than or equal to
The completely random is grouped probability, then distributes the target object according to completely random group technology.
Optionally, when taking out the random number from the preset random sequence, by the row where the random number
It is marked, and the ID number of the target object of the random number will be used to be associated.
Optionally, the essential characteristic of the target object includes at least one of：Prognostic Factors, prognostic level.
In embodiments of the present invention, using obtain target object essential characteristic, and enrolled object between each group
Distribution situation；According to essential characteristic and distribution situation, calculating target object, to be assigned to the totality that each group is brought to system poor
Different degree；The value of each total difference degree is ranked up, determines minimum value, and records the group where minimum value；Judge minimum value
Group number it is whether unique；If the number of the group of minimum value is unique, random number is taken out from preset random sequence, and according to
Random number distributes target object；If the number of the group of minimum value is not unique, in the group of the minimum value of identical total difference degree
A group is randomly selected as target group, target object is distributed to the mode of target group, by using one " random seed ",
Whole random sequences are automatically generated, when dynamic random group technology is needed using random number, directly from generating in advance
It is taken in " random sequence ", has achieved the purpose that " reproducibility " of dynamic random group technology, to realize dynamic random point
The technique effect that group method is applied in Clinical Trials, and then solve dynamic random group technology and do not have reproducibility
Technical problem.
Description of the drawings
Attached drawing described herein is used to provide further understanding of the present invention, and is constituted part of this application, this hair
Bright illustrative embodiments and their description are not constituted improper limitations of the present invention for explaining the present invention.In the accompanying drawings：
Fig. 1 is a kind of flow diagram of optional dynamic random group technology according to the ... of the embodiment of the present invention；
Fig. 2 is the flow diagram of another optional dynamic random group technology according to the ... of the embodiment of the present invention；
Fig. 3 is a kind of structural schematic diagram of optional dynamic random grouping system according to the ... of the embodiment of the present invention.
Specific implementation mode
In order to enable those skilled in the art to better understand the solution of the present invention, below in conjunction in the embodiment of the present invention
Attached drawing, technical scheme in the embodiment of the invention is clearly and completely described, it is clear that described embodiment is only
The embodiment of a part of the invention, instead of all the embodiments.Based on the embodiments of the present invention, ordinary skill people
The every other embodiment that member is obtained without making creative work should all belong to the model that the present invention protects
It encloses.
It should be noted that term " first " in description and claims of this specification and above-mentioned attached drawing, "
Two " etc. be for distinguishing similar object, without being used to describe specific sequence or precedence.It should be appreciated that using in this way
Data can be interchanged in the appropriate case, so as to the embodiment of the present invention described herein can in addition to illustrating herein or
Sequence other than those of description is implemented.In addition, term " comprising " and " having " and their any deformation, it is intended that cover
It includes to be not necessarily limited to for example, containing the process of series of steps or unit, method, system, product or equipment to cover non-exclusive
Those of clearly list step or unit, but may include not listing clearly or for these processes, method, product
Or the other steps or unit that equipment is intrinsic.
Embodiment 1
According to embodiments of the present invention, a kind of embodiment of the method for dynamic random group technology is provided, it should be noted that
Step shown in the flowchart of the accompanying drawings can execute in the computer system of such as a group of computer-executable instructions, and
It, in some cases, can be to execute institute different from sequence herein and although logical order is shown in flow charts
The step of showing or describing.
Fig. 1 is dynamic random group technology according to the ... of the embodiment of the present invention, as shown in Figure 1, this method comprises the following steps：
Step S101 obtains the essential characteristic of target object, and distribution situation of the enrolled object between each group.
In the application above-mentioned steps S101, target object can be new patient, and the essential characteristic of target object includes following
At least one：Prognostic Factors, prognostic level.The essential characteristic of target object can also enter a group time sequencing including patient.
Wherein, prognosis refers to the possibility course of disease and final result of predictive disease.
Step S102 calculates target object and is assigned to each group and brought to system according to essential characteristic and distribution situation
Total difference degree.
Wherein, target object is calculated to be assigned to each group and may include to the total difference degree that system is brought：
If calculating target object assigns to the diversity factor sq (n, p) brought to each layer after certain group；
If calculating target object assigns to the standard deviation sa (n, p) brought to each layer after certain group；
According to the weighted value w (n) of sa (n, p) and each factor, calculates separately target object and be assigned to each group and give system band
The total difference degree come.
Step S103 is ranked up the value of each total difference degree, determines minimum value, and where recording minimum value
Group.
Wherein, the target group by the group where the minimum value as quasi- distribution.
Step S104 judges whether the number of the group of minimum value is unique.
Wherein, after determining minimum value from total difference degree, judge whether the number of the group of minimum value is unique.
Step S105 takes out random number if the number of the group of minimum value is unique from preset random sequence, and according to
Machine number distributes target object.
Optionally, according to random number, distribution target object includes：
Judge whether random number is more than completely random and is grouped probability；
If random number, which is more than completely random, is grouped probability, target object is distributed to target group, target group is minimum value institute
Group；
If random number, which is less than or equal to completely random, is grouped probability, target object is distributed according to completely random group technology.
Wherein, completely random group technology (also referred to as completely randomized design), referring to will using the method for completely random
The study subject of homogeneity is assigned to each processing group, then observes the experimental effect of each group.
Wherein, when taking out random number from preset random sequence, by the traveling line flag where random number, and will make
It is associated with the ID number of the target object of random number.It is specific as shown in table 1：
Table 1
Step S106, if the number of the group of minimum value is not unique, in the group of the minimum value of identical total difference degree with
Machine extracts a group as target group, and target object is distributed to target group.
As shown in Fig. 2, the dynamic random group technology of the present embodiment includes the following steps：
Step A reads the essential characteristic of new patient.
Wherein, the essential characteristic of new patient includes important Prognostic Factors and level.
Step B has entered distribution situation of group patient between each treatment group.
Step C calculates the total difference degree after new patient assigns to each treatment group, brought to system.
Step D is ranked up all diversity factoies, and records the group where minimum value, as the mesh of quasi- distribution
Mark group.
Step E judges whether the number of the group of minimum value is unique.
If so, executing step F；
If it is not, executing step I.
Step F takes out random number if the group of minimum value is unique from preset random sequence.
In the present embodiment, according to the quantity tested into group patient, sufficient amount of random sequence is generated
Step G judges whether that being more than completely random is grouped probability.
If so, executing step J；
If it is not, executing step H.
Step H, according to completely random group technology distribution patient, (completely random distributes patient by random in random sequence
Number determines).
Step I randomly selects one in the minimum value group of same difference degree and is used as mesh if the group of minimum value is not unique
Mark group (patient's grouping is determined by the random number in random sequence).
Step J matches patient according to target components.
In the present embodiment, after the completion of experiment, a group time sequencing, knot can be entered according to the essential characteristic of patient and patient
It closes " stochastic ordering list ", realizes the reproduction of random grouping process
Embodiment 2
According to embodiments of the present invention, a kind of dynamic random grouping system is additionally provided, as shown in figure 3, the dynamic random point
Group system includes acquiring unit 301, the essential characteristic for obtaining target object, and point of the enrolled object between each group
Cloth situation；Computing unit 302, for according to the essential characteristic and the distribution situation, calculating the target object and being assigned to
The total difference degree that each group is brought to system；Processing unit 303 is ranked up, really for the value to each total difference degree
Determine minimum value, and records the group where the minimum value；Judging unit 304, for judging that the number of the group of the minimum value is
It is no unique；Allocation unit 305 is taken out random if the number of the group for the minimum value is unique from preset random sequence
Number, and according to the random number, distribute the target object；If the number of the group of the minimum value is not unique, identical total
A group is randomly selected in the group of the minimum value of body diversity factor as target group, and the target object is distributed to the target
Group.
Optionally, the allocation unit distributes the target object for executing following steps according to the random number：Sentence
Whether the random number of breaking, which is more than completely random, is grouped probability；It, will if the random number, which is more than the completely random, is grouped probability
The target object is distributed to target group, and the target group is the group where the minimum value；If the random number is less than or equal to
The completely random is grouped probability, then distributes the target object according to completely random group technology.
Optionally, when taking out the random number from the preset random sequence, by the row where the random number
It is marked, and the ID number of the target object of the random number will be used to be associated.
Optionally, the essential characteristic of the target object includes at least one of：Prognostic Factors, prognostic level.
The embodiments of the present invention are for illustration only, can not represent the quality of embodiment.
In the above embodiment of the present invention, all emphasizes particularly on different fields to the description of each embodiment, do not have in some embodiment
The part of detailed description may refer to the associated description of other embodiment.
In several embodiments provided herein, it should be understood that disclosed technology contents can pass through others
Mode is realized.Wherein, the apparatus embodiments described above are merely exemplary, for example, the unit division, Ke Yiwei
A kind of division of logic function, formula that in actual implementation, there may be another division manner, such as multiple units or component can combine or
Person is desirably integrated into another system, or some features can be ignored or not executed.Another point, shown or discussed is mutual
Between coupling, direct-coupling or communication connection can be INDIRECT COUPLING or communication link by some interfaces, unit or module
It connects, can be electrical or other forms.
The unit illustrated as separating component may or may not be physically separated, aobvious as unit
The component shown may or may not be physical unit, you can be located at a place, or may be distributed over multiple
On unit.Some or all of unit therein can be selected according to the actual needs to achieve the purpose of the solution of this embodiment.
In addition, each functional unit in each embodiment of the present invention can be integrated in a processing unit, it can also
It is that each unit physically exists alone, it can also be during two or more units be integrated in one unit.Above-mentioned integrated list
The form that hardware had both may be used in member is realized, can also be realized in the form of SFU software functional unit.
If the integrated unit is realized in the form of SFU software functional unit and sells or use as independent product
When, it can be stored in a computer read/write memory medium.Based on this understanding, technical scheme of the present invention is substantially
The all or part of the part that contributes to existing technology or the technical solution can be in the form of software products in other words
It embodies, which is stored in a storage medium, including some instructions are used so that a computer
Equipment (can be personal computer, server or network equipment etc.) execute each embodiment the method for the present invention whole or
Part steps.And storage medium above-mentioned includes：USB flash disk, read-only memory (ROM, Read-Only Memory), arbitrary access are deposited
Reservoir (RAM, Random Access Memory), mobile hard disk, magnetic disc or CD etc. are various can to store program code
Medium.
The above is only a preferred embodiment of the present invention, it is noted that for the ordinary skill people of the art
For member, various improvements and modifications may be made without departing from the principle of the present invention, these improvements and modifications are also answered
It is considered as protection scope of the present invention.
Claims (8)
1. a kind of dynamic random group technology, which is characterized in that including：
Obtain the essential characteristic of target object, and distribution situation of the enrolled object between each group；
According to the essential characteristic and the distribution situation, calculate the target object be assigned to each group brought to system it is total
Body diversity factor；
The value of each total difference degree is ranked up, determines minimum value, and records the group where the minimum value；
Judge whether the number of the group of the minimum value is unique；
If the number of the group of the minimum value is unique, random number is taken out from preset random sequence, and according to the random number,
Distribute the target object；
If the number of the group of the minimum value is not unique, one is randomly selected in the group of the minimum value of identical total difference degree
Group is used as target group, and the target object is distributed to the target group.
2. according to the method described in claim 1, it is characterized in that, described according to the random number, the target object is distributed
Including：
Judge whether the random number is more than completely random and is grouped probability；
If the random number, which is more than the completely random, is grouped probability, the target object is distributed to target group, the target
Group is the group where the minimum value；
If the random number, which is less than or equal to the completely random, is grouped probability, the mesh is distributed according to completely random group technology
Mark object.
3. according to the method described in claim 1, it is characterized in that, described random when being taken out from the preset random sequence
When number, by the traveling line flag where the random number, and the ID number of the target object of the random number will be used to be associated.
4. according to the method in any one of claims 1 to 3, which is characterized in that the essential characteristic packet of the target object
Include at least one of：Prognostic Factors, prognostic level.
5. a kind of dynamic random grouping system, which is characterized in that including：
Acquiring unit, the essential characteristic for obtaining target object, and distribution situation of the enrolled object between each group；
Computing unit, for according to the essential characteristic and the distribution situation, calculating the target object and being assigned to each group
The total difference degree brought to system；
Processing unit is ranked up for the value to each total difference degree, determines minimum value, and records the minimum value place
Group；
Whether judging unit, the number for judging the group of the minimum value are unique；
Allocation unit takes out random number, and root if the number of the group for the minimum value is unique from preset random sequence
According to the random number, the target object is distributed；If the number of the group of the minimum value is not unique, in identical total difference degree
Minimum value group in randomly select a group as target group, the target object is distributed to the target group.
6. system according to claim 5, which is characterized in that the allocation unit is for executing following steps according to
Random number distributes the target object：
Judge whether the random number is more than completely random and is grouped probability；
If the random number, which is more than the completely random, is grouped probability, the target object is distributed to target group, the target
Group is the group where the minimum value；
If the random number, which is less than or equal to the completely random, is grouped probability, the mesh is distributed according to completely random group technology
Mark object.
7. system according to claim 5, which is characterized in that described random when being taken out from the preset random sequence
When number, by the traveling line flag where the random number, and the ID number of the target object of the random number will be used to be associated.
8. system according to any one of claims 5 to 7, which is characterized in that the essential characteristic packet of the target object
Include at least one of：Prognostic Factors, prognostic level.
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|---|---|---|---|
| CN201810386928.6A CN108597563A (en) | 2018-04-26 | 2018-04-26 | Dynamic random group technology and system |
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| CN201810386928.6A CN108597563A (en) | 2018-04-26 | 2018-04-26 | Dynamic random group technology and system |
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| CN114188037A (en) * | 2021-12-15 | 2022-03-15 | 浙江太美医疗科技股份有限公司 | Method, apparatus, device and medium for randomly grouping subjects in a clinical study |
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| CN114188037A (en) * | 2021-12-15 | 2022-03-15 | 浙江太美医疗科技股份有限公司 | Method, apparatus, device and medium for randomly grouping subjects in a clinical study |
| CN114220504A (en) * | 2021-12-15 | 2022-03-22 | 浙江太美医疗科技股份有限公司 | Random grouping method, device and equipment |
| CN114188037B (en) * | 2021-12-15 | 2024-10-18 | 浙江太美医疗科技股份有限公司 | Methods, apparatus, devices and media for randomized grouping of subjects in clinical studies |
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