Umbrella trial for clinical trial design of oncology drugs / 中国胸心血管外科临床杂志
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery
;
(12): 1228-1234, 2023.
Artículo
en Chino
| WPRIM
| ID: wpr-996951
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.
Texto completo:
Disponible
Índice:
WPRIM (Pacífico Occidental)
Idioma:
Chino
Revista:
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery
Año:
2023
Tipo del documento:
Artículo
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