Method, device and equipment for generating clinical test scheme based on BOIN design decision

A technology for clinical trials and design decisions, applied in the field of clinical trials, can solve the problems of increasing human costs and long time consumption of clinical trials

Pending Publication Date: 2022-04-15
CLINDATA PHARM BIOTECHNOLOGY (BEIJING) CO LTD
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Problems solved by technology

[0004] However, the current BOIN-based design and decision-making clinical trial plans are mostly manually generated, which not only takes a long time, but also increases the human cost of clinical trials

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  • Method, device and equipment for generating clinical test scheme based on BOIN design decision
  • Method, device and equipment for generating clinical test scheme based on BOIN design decision

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Embodiment Construction

[0038] In order to make the purpose, technical solution and advantages of the present invention clearer, the technical solution of the present invention will be described in detail below. Apparently, the described embodiments are only some of the embodiments of the present invention, but not all of them. Based on the embodiments of the present invention, all other implementations obtained by persons of ordinary skill in the art without making creative efforts fall within the protection scope of the present invention.

[0039] A kind of method based on Bayesian optimal interval (BOIN) design decision-making clinical trial scheme, is characterized in that, comprises:

[0040] S11. Acquiring basic data for generating a clinical trial plan based on BOIN design decision;

[0041] The Bayesian optimal interval design is referred to as BOIN design for short.

[0042] In practical applications, the basic data can be collected through an electronic data acquisition system, and the el...

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Abstract

The invention relates to the field of clinical tests, in particular to a method, a device and equipment for generating a clinical test scheme based on Bayesian optimal interval (BOIN) design decision. The method comprises the following steps: firstly, acquiring basic data for generating a clinical test scheme based on BOIN design decision; basic elements of a clinical test scheme based on BOIN design decision are formulated; according to the basic elements, making a basic element flow chart and a report of a clinical test scheme based on BOIN design decision; according to the flow chart and the report, making a database structure description file based on a BOIN design decision clinical test scheme; according to the database structure description file, making a database based on a BOIN design decision clinical test scheme; and finally, according to the database, generating a clinical test scheme based on BOIN design decision. According to the invention, the clinical test scheme based on the BOIN design decision can be automatically generated, and manual making of the clinical test scheme based on the BOIN design decision is avoided, so that the clinical test development time is shortened, and the clinical test cost is reduced.

Description

technical field [0001] The present application relates to the technical field of clinical trials, in particular to a method, device and equipment for designing and decision-making clinical trial schemes based on Bayesian Optimal Interval (BOIN). Background technique [0002] Clinical trials are systems designed to discover or verify the clinical medicine, pharmacology, and other pharmacodynamic effects, adverse reactions, or absorption, distribution, metabolism, and excretion of an experimental drug in order to determine the efficacy and safety of the drug. sex test. [0003] BOIN (Bayesian Optimal Interval) design is an optimal interval design based on Bayesian method. The design of the BOIN method is based on the following concept. For a "perfect" phase I clinical trial design, the dose should be increased when the current dose level is actually lower than the maximum tolerated dose (MTD); the dose should be decreased when the current dose level is actually higher than th...

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G16H10/20G06F16/21
Inventor 郭东升史绮霞李春燕王晔
Owner CLINDATA PHARM BIOTECHNOLOGY (BEIJING) CO LTD
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