CN111863160B

CN111863160B - Random granule allocation method in IRT system

Info

Publication number: CN111863160B
Application number: CN202010736950.6A
Authority: CN
Inventors: 王卫煜
Original assignee: Jiaxing Yidixi Computer Technology Co ltd
Current assignee: Yidixi Pharmaceutical Technology Jiaxing Co ltd
Priority date: 2020-07-28
Filing date: 2020-07-28
Publication date: 2023-11-10
Anticipated expiration: 2040-07-28
Also published as: CN111863160A

Abstract

The invention provides a random granule allocation method in an IRT system, which comprises the following steps: s1, dividing all random numbers according to groups, and then placing the random numbers into a central warehouse; s2, one or more granules in the central warehouse are automatically or manually distributed to the corresponding centers. The centers compete for the granules in the random warehouse, the granules are not required to be distributed to each center, and the number of random numbers is saved.

Description

Random granule allocation method in IRT system

Technical Field

The invention belongs to the technical field of randomized clinical trials, and particularly relates to a method for allocating randomized block in an IRT system.

Background

Randomization is the fundamental principle of clinical trial design. The randomization method which is widely applied in clinical trials at present is a block randomization method. Group randomization divides all subjects of the whole test into a plurality of groups, subjects with the same or similar characteristics are classified into the same group, and then randomization is performed in the group according to the proportion, so that the test group and the control group are balanced in the group, thereby completing randomization and balancing of the whole test.

In the "statistical guidelines for clinical trials (ICH E9)" it is stated that "in a multicenter trial, the randomization process should be organized centrally. It is advocated to build a separate random table for each center, i.e. to layer by center, or to group some whole blocks into one center. To achieve equalization among centers, in IRT systems, a random table is typically built up for each center alone, or all groups of groups are equally distributed to centers, each having a portion of the entire group.

However, the prior art random method has the following disadvantages:

1. because it is difficult to estimate the number of persons entering the group at each center in the random stage of the test start, a large number of random numbers need to be generated for each center in order to ensure that the random numbers at each center are sufficient. If the test is a double-blind test, and the random number is the same as the medicine number, a large amount of medicine waste can be caused.

2. If there are new centers in the test process, the random table is generated for each center independently or all groups are allocated, so that the random table needs to be regenerated for the new centers, and the complexity of the test is increased.

3. If the sample size is increased or a certain central group number exceeds the expected value in the test process, a certain central random number is insufficient, and the re-random is needed.

Disclosure of Invention

The invention aims to solve the problems and provides a random granule allocation method in an IRT system.

In order to achieve the above purpose, the present invention adopts the following technical scheme:

a random granule allocation method in an IRT system comprises the following steps:

s1, dividing all random numbers according to groups, and then placing the random numbers into a central warehouse;

s2, one or more granules in the central warehouse are automatically or manually distributed to the corresponding centers.

In the above method for allocating random granule groups in IRT system, the central warehouse is reserved with reserved granule groups, and after step S2, the method further includes:

and if the new center exists in the experimental process, the reserved block group in the random warehouse is distributed to the new center.

In the above method for allocating random granule in IRT system, step S2 further includes:

and the centers mutually allocate the granule groups and random numbers of the granule groups according to the utilization condition of the allocated granule groups.

In the above method for allocating random granule in IRT system, the allocation method comprises:

if a certain center is allocated with a redundant granule or granule random number after the granule is allocated, the redundant granule or granule random number is allocated to other centers or is allocated back to a central warehouse.

In the above method for allocating random granule in IRT system, if the experimental mode is hierarchical random according to the center, step S2 includes:

and acquiring the random number, distributing the granule corresponding to the random number to the corresponding center, and enabling the random number in the granule not to be distributed by other centers.

In the above method for allocating random granule in IRT system, if the experimental mode is non-central hierarchical random, step S2 includes:

and acquiring the random numbers, distributing the granules corresponding to the random numbers to corresponding centers, and when the centers do not use all the random numbers in the granules, distributing redundant random numbers by other centers.

In the above method for allocating random granule in IRT system, the manual allocation method includes:

A1. after the experiment is started, the corresponding granules are manually distributed to the corresponding centers entirely by a user;

A2. when a certain center has insufficient random numbers or a new center is added, the random numbers which are not used by other centers are allocated to the center.

In the above random granule allocation method in IRT system, the automatic allocation method includes:

B1. uploading a random table containing at least one random number of each granule to an IRT system;

B2. after the random operation starts, randomly selecting a random number in a random table for the center;

B3. the subsequent random numbers of the center are preferentially distributed in the granules where the selected random numbers are located;

B4. if the experimental mode is non-central hierarchical randomness, the granules in the step B3 are reserved in a random warehouse;

if the experimental mode is hierarchical random according to the center, deleting the granules in the step B3 from the random warehouse.

The invention has the advantages that: each center competes for the granule group in the random warehouse, and the granule group is not required to be distributed to each center, so that the number of random numbers is saved; when a center is newly added in the experimental process, a random table does not need to be generated again; when the random number of a certain center is insufficient, the allocation can be carried out from other centers.

Drawings

FIG. 1 is a schematic diagram of a method for allocating random granules in an IRT system according to the invention.

Detailed Description

The invention will be described in further detail with reference to the drawings and the detailed description.

The embodiment discloses a random granule allocation method in an IRT system, which comprises the following steps:

s2, automatically or manually distributing one or more granules in the central warehouse to the corresponding centers;

s3, the centers allocate the granules and random numbers of the granules according to the utilization condition of the allocated granules.

Specifically, the blending method comprises the following steps:

if a certain center is allocated with a redundant granule or granule random number, the unused granule or granule random number is allocated to other centers or back to the central warehouse.

As shown in FIG. 1, granules 1, 2 and 3 of the central repository are manually or automatically allocated to center 01, then the unused granule 3 of center 01 is allocated back to the central repository, and the unused granule 2 of center 01 is allocated to center 02. For example, if there are 4 numbers in granule 2 and 1 number is used by center 01, then granule 2 may be allocated to center 02 and the remaining 3 numbers in granule 2 may be used for center 02, i.e., after center 01 is allocated to granule 2, the remaining 3 random numbers of granule 2 are allocated to center 02.

Preferably, the central warehouse is reserved with a reservation granule group, and further comprises, after step S2:

if the new center is provided in the experimental process, the reserved block group in the random warehouse is distributed to the new center so as to ensure that the random numbers of all centers are sufficient. The random number is reduced as much as possible on the premise of ensuring the sufficient random number, so as to lighten the burden of the system.

Specifically, the experimental mode is divided into random according to the center layering and random according to the non-center layering, and if the experimental mode is random according to the center layering, the step S2 includes:

If the experimental mode is non-central hierarchical random, step S2 includes:

and acquiring random numbers, distributing the granules corresponding to the random numbers to corresponding centers, and when the centers do not distribute all the random numbers in the granules, distributing the redundant random numbers by other centers.

Specifically, the manual distribution method includes:

A1. after the experiment is started, the user manually distributes the corresponding granule group to the corresponding center entirely, so that the whole granule group is ensured to be preferentially used in one center and not used in other centers;

A2. when a random number of a certain center is insufficient or a new center is added, the random number which is not used by other centers can be allocated to the center with the insufficient or the new center.

The manual distribution mode can ensure balance among centers, and is mainly aimed at non-center layering randomness.

Further, the automatic allocation method includes:

B1. uploading a random table containing at least one random number of each granule to an IRT system; the random table of this embodiment contains all the random numbers, and when an entire granule is allocated by a center, the random number corresponding to the entire granule is removed from the random table.

the center subsequent random number pointed in B3.B2 is preferentially distributed in the granule where the selected random number is located;

B4. if the experimental mode is non-central hierarchical randomness, the granules in the step B3 are reserved in a random warehouse; other centers can still allocate random numbers in the granule, for example, the A granule itself has 4 random numbers, 2 random numbers are used by the B center in steps B2 and B3, the rest 2 random numbers remain in the random warehouse, the rest 2 random numbers remain in the random table, and other centers can still allocate the 2 rest random numbers;

if the experimental mode is layering random according to the center, deleting the granules in the step B3 from the random warehouse, and deleting all random numbers in the granules in the random table. Other centers cannot allocate random numbers in this granule.

The embodiment sets the concept of a random warehouse, all random numbers are stored in a central warehouse in a concentrated mode, the centralized management of the random numbers is achieved, and when needed, the operation of distributing an entire granule to the center can be performed manually or automatically. The random principle of experiments and the balance among centers are ensured, a large number of random numbers are saved, the group of the centers is increased, the resources of clinical experiments are saved, and the complexity of the experiments is reduced.

Further, when the method is put into use, the problem of medicine waste can be solved under the condition that the random number is the same as the medicine number, and the specific mode is as follows: the medicines are labeled, the medicine numbers are set to be the same as the random numbers, when one granule is distributed to a fixed center, the medicines with the medicine numbers which are the same as the random numbers of the granule are transported to the center in advance, and after the random numbers, the corresponding medicines are taken.

The specific embodiments described herein are offered by way of example only to illustrate the spirit of the invention. Those skilled in the art may make various modifications or additions to the described embodiments or substitutions thereof without departing from the spirit of the invention or exceeding the scope of the invention as defined in the accompanying claims.

Although the terms random number, central repository, center, reserved block, etc. are used more herein, the possibility of using other terms is not precluded. These terms are used merely for convenience in describing and explaining the nature of the invention; they are to be interpreted as any additional limitation that is not inconsistent with the spirit of the present invention.

Claims

1. The random granule allocation method in the IRT system is characterized by comprising the following steps:

s2, distributing one or more granules in the central warehouse to corresponding centers;

s3, the centers allocate the granules and random numbers of the granules according to the utilization condition of the allocated granules;

in step S2, the allocation method includes:

B4. if the experimental mode is non-central hierarchical random, the granules in the step B3 are reserved in a random warehouse, and other centers can still distribute random numbers in the granules;

if the experimental mode is layering and random according to the center, deleting the granules in the step B3 from a random warehouse, wherein other centers cannot distribute random numbers in the granules;

in step S3, the blending method includes:

2. The method for allocating random granules in IRT system according to claim 1, wherein a reserved granule is reserved in the central warehouse, and further comprising, after step S2: