CN111916176A - Double-blind medicine clinical test method and system - Google Patents
Double-blind medicine clinical test method and system Download PDFInfo
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- CN111916176A CN111916176A CN201910376442.9A CN201910376442A CN111916176A CN 111916176 A CN111916176 A CN 111916176A CN 201910376442 A CN201910376442 A CN 201910376442A CN 111916176 A CN111916176 A CN 111916176A
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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
- G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
- G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
- G16H20/13—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered from dispensers
Abstract
The invention discloses a double-blind medicine clinical test method and a double-blind medicine clinical test system. Wherein, the method comprises the following steps: generating a random distribution table, a medicine number table and a secondary blind bottom comparison table; extracting a first random number from the random distribution table and distributing the first random number to a target object; obtaining a group corresponding to the first random number from the secondary blind bottom comparison table; and distributing the grouped corresponding medicines to the target object from the medicine distribution table according to the descending order of the medicine numbers. The invention solves the technical problem of drug waste in the existing blind clinical test.
Description
Technical Field
The invention relates to the field of clinical tests of medicines, in particular to a double-blind medicine clinical test method and a double-blind medicine clinical test system.
Background
The new drug clinical test refers to any systematic study of drugs in human body (patient or healthy volunteer) to confirm or discover the clinical, pharmacological and/or other pharmacodynamic effects, adverse reactions and/or absorption, distribution, metabolism and excretion of the tested drugs, so as to determine the safety and effectiveness of the tested drugs and provide basis for the marketing of innovative drugs (or imitation drugs). In order to obtain a more objective effect, a series of measures are taken, so that the person influencing the clinical trial result does not know which patient receives what treatment when the patient receives treatment, even when the statistical analysis is carried out, and the measures are generally called as 'blinding'. Tests performed "blinded" are referred to as "blind clinical tests".
In a blind clinical trial, a patient will receive a medication number corresponding to a treatment group. If multiple administrations are required, all the medications are packaged in one large package. If the medication is expensive and the patient withdraws from the trial halfway, the remaining medication can be wasted significantly. Moreover, if a small portion of the drug is damaged during transportation due to storage environment or other factors, the remaining intact portion of the drug cannot be used at the same time.
In view of the above problems, no effective solution has been proposed.
Disclosure of Invention
The embodiment of the invention provides a double-blind medicine clinical test method and a double-blind medicine clinical test system, which at least solve the technical problem of medicine waste in the existing blind method clinical test.
According to an aspect of an embodiment of the present invention, there is provided a double-blind clinical trial method for a drug, including: generating a random distribution table, a medicine number table and a secondary blind bottom comparison table; extracting a first random number from the random distribution table and distributing the first random number to a target object; obtaining a group corresponding to the first random number from the secondary blind bottom comparison table; and distributing the grouped corresponding medicines to the target object from the medicine distribution table according to the descending order of the medicine numbers.
Optionally, the random allocation table includes a random number, a packet number, a granule, and a random number.
Optionally, the medication number table includes a medication number, a block, a nonce, a group description.
Optionally, the second-level blind bottom comparison table includes a packet number and a packet description, and is used to indicate a correspondence between the packet number and the packet description.
Optionally, the target object is assigned the same grouping of medications multiple times.
According to another aspect of the embodiments of the present invention, there is also provided a double-blind clinical trial system for a drug, including: an input unit for receiving basic information of a target object; the screening unit is used for screening the target object based on the basic information and a preset inclusion and exclusion standard; the processing unit is used for extracting a first random number from a random distribution table generated in advance and distributing the first random number to the target object; obtaining a group corresponding to the first random number from a pre-generated secondary blind bottom comparison table; and distributing the grouped corresponding medicines to the target object according to the descending order of the medicine numbers from the medicine distribution table generated in advance.
Optionally, the random allocation table includes a random number, a packet number, a granule, and a random number.
Optionally, the medication number table includes a medication number, a block, a nonce, a group description.
Optionally, the second-level blind bottom comparison table includes a packet number and a packet description, and is used to indicate a correspondence between the packet number and the packet description.
Optionally, the target object is assigned the same grouping of medications multiple times.
In the embodiment of the invention, a random distribution table, a medicine number table and a secondary blind bottom comparison table are generated; extracting a first random number from the random distribution table and distributing the first random number to a target object; obtaining a group corresponding to the first random number from the secondary blind bottom comparison table; from the medicine distribution table, the corresponding medicines of the groups are distributed to the target object according to the sequence of the medicine numbers from small to large, the corresponding groups are determined by the random numbers by using a method of separating the random numbers from the medicine numbers, and the aim of optimizing the medicine management and distribution process is fulfilled, so that the technical effect of saving the medicines is realized, and the technical problem of medicine waste in the conventional blind clinical test is solved.
Drawings
The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this application, illustrate embodiment(s) of the invention and together with the description serve to explain the invention without limiting the invention. In the drawings:
FIG. 1 is a schematic flow diagram of an alternative method for double-blind clinical trials of drugs in accordance with an embodiment of the present invention;
FIG. 2 is a schematic diagram of an alternative double-blind clinical trial system for medications according to an embodiment of the present invention;
FIG. 3 is a schematic illustration of a display interface of an alternative double-blind clinical trial system for medications according to an embodiment of the present invention;
FIG. 4 is a schematic view of a display interface of an alternative double-blind clinical trial system for medications according to an embodiment of the present invention;
FIG. 5 is a schematic diagram of a display interface of yet another alternative double-blind clinical trial system for medications according to an embodiment of the present invention.
Detailed Description
In order to make the technical solutions of the present invention better understood, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
It should be noted that the terms "first," "second," and the like in the description and claims of the present invention and in the drawings described above are used for distinguishing between similar elements and not necessarily for describing a particular sequential or chronological order. It is to be understood that the data so used is interchangeable under appropriate circumstances such that the embodiments of the invention described herein are capable of operation in sequences other than those illustrated or described herein. Furthermore, the terms "comprises," "comprising," and "having," and any variations thereof, are intended to cover a non-exclusive inclusion, such that a process, method, system, article, or apparatus that comprises a list of steps or elements is not necessarily limited to those steps or elements expressly listed, but may include other steps or elements not expressly listed or inherent to such process, method, article, or apparatus.
Example 1
In accordance with an embodiment of the present invention, there is provided a method embodiment of a double-blind clinical trial method of medication, it being noted that the steps illustrated in the flowchart of the drawings may be performed in a computer system such as a set of computer-executable instructions and that, although a logical order is illustrated in the flowchart, in some cases the steps illustrated or described may be performed in an order different than presented herein.
Fig. 1 is a double-blind clinical trial method for drugs according to an embodiment of the present invention, as shown in fig. 1, the method comprising the steps of:
step S101, generating a random distribution table, a medicine number table and a secondary blind bottom comparison table.
In the above step S101, at the beginning of the test, 2 random comparison tables (i.e. random distribution table, drug number table) and 1 second-level blind bottom comparison table are generated.
The random allocation table includes a random number, a packet number, a block, and a random number, and is specifically shown in table 1:
TABLE 1
| Random number | Packet numbering | Block of medicine | Random number |
| R0001 | B | 1 | 2 |
| R0002 | A | 1 | 1 |
| R0003 | B | 1 | 4 |
| R0004 | A | 1 | 3 |
| R0005 | B | 2 | 4 |
| R0006 | A | 2 | 1 |
| R0007 | A | 2 | 3 |
| R0008 | B | 2 | 2 |
| R0009 | B | 3 | 4 |
| R0010 | B | 3 | 2 |
| R0011 | A | 3 | 1 |
| R0012 | A | 3 | 3 |
| R0013 | B | 4 | 4 |
| R0014 | A | 4 | 1 |
| R0015 | B | 4 | 2 |
| R0016 | A | 4 | 3 |
| … | … | … | … |
Optionally, the drug number table includes drug numbers, blocks, random numbers, and grouping descriptions, specifically as shown in table 2:
TABLE 2
Optionally, the secondary blind bottom comparison table includes a packet number and a packet description, and is used to indicate a correspondence between the packet number and the packet description, and is specifically shown in table 3:
TABLE 3
| Packet numbering | Packet description |
| A | Control group |
| B | Test group |
As shown in Table 3, the treatment groups of group numbers "A" and "B" correspond to the "test group" and the "control group".
Step S102, a first random number is extracted from the random distribution table and distributed to the target object.
In the above step S102, the target object may be a patient, and after the patient is grouped, the corresponding random number and the grouping number are sequentially obtained from the "random allocation table" as the grouping basis of the patient.
And step S103, acquiring a group corresponding to the first random number from the secondary blind bottom comparison table.
And step S104, distributing the grouped corresponding medicines to the target object from the medicine distribution table according to the descending order of the medicine numbers.
In the above steps S103 to S104, the group corresponding to the first random number is searched from the second-level blind bottom comparison table, and the drugs with the corresponding treatment group numbers are sequentially selected from the "drug number table" according to the sequence of the drug numbers from small to large and are distributed to the patients for use.
It should be noted that the target object may be assigned the same group of drugs multiple times, i.e. the patient may take the drugs multiple times from the "drug number table".
In this embodiment, the remaining drugs can be freely dispensed among the test centers.
Example 2
According to an embodiment of the present invention, there is also provided a double-blind clinical trial system for a drug, as shown in fig. 2, the double-blind clinical trial system for a drug including: an input unit 201 for receiving basic information of a target object; a screening unit 202, configured to screen the target object based on the basic information and a preset inclusion/exclusion criterion; a processing unit 203 for extracting a first random number from a random allocation table generated in advance to allocate to a target object; obtaining a group corresponding to the first random number from a pre-generated secondary blind bottom comparison table; from the medicine allocation table generated in advance, the group-corresponding medicines are allocated to the target object in the order of the medicine numbers from small to large.
Optionally, the random allocation table includes a random number, a packet number, a granule, and a random number.
Optionally, the medication number table includes a medication number, a block, a random number, a group description.
Optionally, the second-level blind bottom comparison table includes a packet number and a packet description, and is used to indicate a correspondence between the packet number and the packet description.
Optionally, the target object is assigned the same grouping of medications multiple times.
Next, as shown in fig. 3 to 5, the double-blind clinical trial system for drugs of the present embodiment will be described:
the first step is as follows: the user logs in the double-blind drug clinical trial system.
The second step is that: the user enters basic information (subject name abbreviation, subject gender, subject date of birth).
The third step: inclusion and exclusion of subjects.
The double-blind clinical trial system of this example compares the new subject profile with the inclusion/exclusion criteria of the trial on a case by case basis, and enters the randomization phase if the subject meets the "inclusion/exclusion criteria". Otherwise, the subject is excluded.
The fourth step: grouping information of the subjects.
Subjects entered the randomization process by screening for "inclusion/exclusion criteria".
The fifth step: treatment group information assigned to the subject is obtained.
Extracting a first random number from a random allocation table generated in advance and allocating the first random number to a subject; obtaining a group corresponding to the first random number from a pre-generated secondary blind bottom comparison table; from the previously generated medication allocation table, the group-corresponding medications are allocated to the subjects in the order of the medication numbers from small to large.
And a sixth step: drug numbers were obtained for subjects on the 2 nd to 12 th medication.
As shown in fig. 3 and 4, the subject has the random number R0058, the first drug number D1247, and the second drug number D1249.
Further, as shown in fig. 5, per-dose information of the subject may be displayed.
In this embodiment, if a certain subject already obtains the drug number through the system, but finds that the drug is damaged during drug delivery, the system may add one drug delivery opportunity to the subject.
The above-mentioned serial numbers of the embodiments of the present invention are merely for description and do not represent the merits of the embodiments.
In the above embodiments of the present invention, the descriptions of the respective embodiments have respective emphasis, and for parts that are not described in detail in a certain embodiment, reference may be made to related descriptions of other embodiments.
In the embodiments provided in the present application, it should be understood that the disclosed technology can be implemented in other ways. The above-described embodiments of the apparatus are merely illustrative, and for example, the division of the units may be a logical division, and in actual implementation, there may be another division, for example, multiple units or components may be combined or integrated into another system, or some features may be omitted, or not executed. In addition, the shown or discussed mutual coupling or direct coupling or communication connection may be an indirect coupling or communication connection through some interfaces, units or modules, and may be in an electrical or other form.
The units described as separate parts may or may not be physically separate, and parts displayed as units may or may not be physical units, may be located in one place, or may be distributed on a plurality of units. Some or all of the units can be selected according to actual needs to achieve the purpose of the solution of the embodiment.
In addition, functional units in the embodiments of the present invention may be integrated into one processing unit, or each unit may exist alone physically, or two or more units are integrated into one unit. The integrated unit can be realized in a form of hardware, and can also be realized in a form of a software functional unit.
The integrated unit, if implemented in the form of a software functional unit and sold or used as a stand-alone product, may be stored in a computer readable storage medium. Based on such understanding, the technical solution of the present invention may be embodied in the form of a software product, which is stored in a storage medium and includes instructions for causing a computer device (which may be a personal computer, a server, or a network device) to execute all or part of the steps of the method according to the embodiments of the present invention. And the aforementioned storage medium includes: a U-disk, a Read-Only Memory (ROM), a Random Access Memory (RAM), a removable hard disk, a magnetic or optical disk, and other various media capable of storing program codes.
The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, various modifications and decorations can be made without departing from the principle of the present invention, and these modifications and decorations should also be regarded as the protection scope of the present invention.
Claims (10)
1. A double blind clinical trial method for a drug comprising:
generating a random distribution table, a medicine number table and a secondary blind bottom comparison table;
extracting a first random number from the random distribution table and distributing the first random number to a target object;
obtaining a group corresponding to the first random number from the secondary blind bottom comparison table;
and distributing the grouped corresponding medicines to the target object from the medicine distribution table according to the descending order of the medicine numbers.
2. The method of claim 1, wherein the random allocation table comprises a random number, a packet number, a granule, and a random number.
3. The method of claim 1, wherein the drug number table comprises drug numbers, blocks, random numbers, group descriptions.
4. The method according to claim 1, wherein the secondary blind bottom comparison table comprises a packet number and a packet description, and is used for indicating a correspondence between the packet number and the packet description.
5. The method of any one of claims 1 to 4, wherein the target subject is assigned the same group of medications multiple times.
6. A double-blind clinical trial system for medications comprising:
an input unit for receiving basic information of a target object;
the screening unit is used for screening the target object based on the basic information and a preset inclusion and exclusion standard;
the processing unit is used for extracting a first random number from a random distribution table generated in advance and distributing the first random number to the target object; obtaining a group corresponding to the first random number from a pre-generated secondary blind bottom comparison table; and distributing the grouped corresponding medicines to the target object according to the descending order of the medicine numbers from the medicine distribution table generated in advance.
7. The system of claim 6, wherein the random allocation table comprises a nonce, a packet number, a granule, and a nonce.
8. The system of claim 6, wherein the medication number table comprises medication numbers, blocks, random numbers, group descriptions.
9. The system according to claim 6, wherein the secondary blind bottom comparison table comprises a packet number and a packet description, and is used for indicating the corresponding relationship between the packet number and the packet description.
10. The system of any one of claims 6 to 9, wherein the target subject is assigned the same group of medications multiple times.
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