Umbrella trial for clinical trial design of oncology drugs
- VernacularTitle:肿瘤药物临床试验设计之伞式试验
- Author:
Xiaoqin ZHOU
1
,
2
;
Huizhen LIU
3
;
Ting WANG
3
;
Xu LI
3
;
Fanfan SHI
3
;
Deying KANG
1
,
2
Author Information
1. 1. Center of Biostatistics, Design, Measurement and Evaluation (CBDME), Department of Clinical Research Management, West China Hospital, Sichuan University, Chengdu, 610041, P. R. China
2. 2. Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, 610041, P. R. China
3. Center of Biostatistics, Design, Measurement and Evaluation (CBDME), Department of Clinical Research Management, West China Hospital, Sichuan University, Chengdu, 610041, P. R. China
- Publication Type:Journal Article
- Keywords:
Precision medicine;
oncology drugs clinical trials;
umbrella trial;
same disease with different treatments
- From:
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery
2023;30(09):1228-1234
- CountryChina
- Language:Chinese
-
Abstract:
The umbrella trial has received increasing attention in the design of clinical trials for oncology drugs in recent years. This trial design categorizes a single disease into multiple sub-types based on predictive biomarkers or other predictive factors, and simultaneously evaluates the efficacy of multiple targeted therapies. When compared with the traditional drug development model of phase Ⅰ, phaseⅡ, and phase Ⅲ randomized controlled trials, umbrella trials are a more scientifically rigorous trial design that can speed up drug evaluation to address the conflict between numerous untested drugs and diseases with a lack of effective treatment options. This article will focus on the concept, main characteristics, eligibility criteria, design and statistical considerations, ethical considerations, and future directions of umbrella trials, with the aim of providing methodological guidance for the design of clinical trials for oncology drugs.
