Phase II Trials in Drug Development and Adaptive Trial Design

Phase II clinical studies represent a critical point in determining drug costs, and phase II is a poor predictor of drug success: >30% of drugs entering phase II studies fail to progress, and >58% of drugs go on to fail in phase III. Adaptive clinical trial design has been proposed as a way to...

Descripción completa

Detalles Bibliográficos
Autor principal: Van Norman, Gail A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2019
Materias:
TRANSLATIONAL TOOLBOX
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6609997/
https://www.ncbi.nlm.nih.gov/pubmed/31312766
http://dx.doi.org/10.1016/j.jacbts.2019.02.005
Descripción
Sumario:Phase II clinical studies represent a critical point in determining drug costs, and phase II is a poor predictor of drug success: >30% of drugs entering phase II studies fail to progress, and >58% of drugs go on to fail in phase III. Adaptive clinical trial design has been proposed as a way to reduce the costs of phase II testing by providing earlier determination of futility and prediction of phase III success, reducing overall phase II and III trial sizes, and shortening overall drug development time. This review examines issues in phase II testing and adaptive trial design.

Ejemplares similares