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

A technology for clinical trials and design decisions, applied in the field of clinical trials, can solve the problems of slow time-consuming, increased human costs of clinical trials, etc.

Pending Publication Date: 2022-04-12
CLINDATA PHARM BIOTECHNOLOGY (BEIJING) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, the current BOPII-based design and decision-making clinical trial plans are mostly manually generated, which is not only time-consuming and slow, but also increases the human cost of clinical trials

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0073] Example 1: Binary Efficacy Endpoint: A phase II clinical trial to evaluate the efficacy of metformin in patients with recurrent small cell lung cancer. The primary endpoint was the objective response rate (ORR) (defined using RECIST version 1.1) of ASO-treated patients with relapsed small cell lung cancer (SCLC). According to historical data, if the original hypothesis ORR5% is established, the treatment is considered to be ineffective, and if the alternative hypothesis ORR20% is established, it is considered that the therapy has development prospects. This example is used to illustrate the standard case with a binary efficacy endpoint.

example 2

[0074] Example 2: Nested efficacy endpoints: a phase II clinical trial to evaluate the efficacy of a novel humanized monoclonal antibody in patients with Hodgkin lymphoma who had failed autologous stem cell transplantation. The effectiveness of lymphoma therapy is defined using the revised International Malignant Lymphoma Working Group Criteria, with one of four reduction level categories including: Complete Response (CR), defined as disappearance of all evidence of disease; Partial Response (PR), defined as regression of measurable lesions with no new lesions; stable disease (SD), defined as failure to meet criteria for CR, PR, or progressive disease (PD); progressive disease (PD), defined as progression of any new lesions Evidence or lesion volume increased by 50% from the nadir of the previously involved site. In this trial, although both CR and PR were considered favorable efficacy responses, CR was actually preferable. The null hypothesis is that Pr(CR+PR) is 30% and Pr(...

example 3

[0075] Example 3: Co-multiple efficacy endpoints: a phase II clinical trial, the protocol name is GOG 0229E, the main purpose is to study the efficacy of bevacizumab in patients with recurrent or persistent endometrial cancer. The trial has two co-primary efficacy endpoints: the objective response rate (ORR) and the probability of 6-month progression-free (or death) survival (PFS6). Objective response rate was defined using Evaluation Criteria in Solid Tumors (RECIST) 1.1. Progression-free survival (PFS) was defined as the time from the start of treatment to disease progression or death from any cause. The null hypothesis is ORR10% and PFS615%. If established, the treatment is considered ineffective. The difference between the clinically significant improvement of the two indicators is 20%, so if the alternative hypothesis ORR≥30% or PFS6≥35% is established, it is considered that the therapy has development prospects.

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Abstract

The invention relates to the field of clinical trials, in particular to a method, a device and equipment for generating a clinical test scheme based on Bayesian optimal phase II (BOPI) design decision. The method comprises the following steps: firstly, acquiring basic data for generating a clinical test scheme based on BOPII design decision; basic elements of a clinical test scheme based on BOPII 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 BOPII design decision; according to the flow chart and the report, making a database structure description file of a clinical test scheme based on BOPII design decision; according to the database structure description file, formulating a database of a clinical test scheme based on BOPII design decision; and finally, according to the database, generating a clinical test scheme based on BOPII design decision. According to the method and the device, the clinical test scheme based on the BOPII design decision can be automatically generated, and manual making of the clinical test scheme based on the BOPII 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 trials based on Bayesian Optimal Phase II (BOPII). 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] Clinical trial protocol (Protocol) refers to the documents that describe the purpose, design, methodology, statistical considerations and organizational implementation of clinical trials. The trial protocol usually also includes the background and theoretical basis of the clinical trial, which can be given in other reference documents. The trial protocol describes in detail how to implement a clinical trial...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G16H20/00G16H10/00G06F16/22G06N7/00
Inventor 郭东升史绮霞
Owner CLINDATA PHARM BIOTECHNOLOGY (BEIJING) CO LTD
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