A framework: make it useful to guide and improve practice of clinical trial design in smaller populations

BMC Medicine

Commentary

Kit C. B. Roes¹ 

[1] Julius Centre for Health Sciences and Primary Care, Biostatistics and Research Support, University Medical Center Utrecht, Utrecht, The Netherlands;

关键词: Randomised clinical trials;    Clinical trial design;    Protocol development;    Rare diseases;   

DOI  :  10.1186/s12916-016-0752-x

 received in 2016-11-17, accepted in 2016-11-18,  发布年份 2016

来源: Springer

【 摘 要 】

The increased attention to design and analysis of randomised clinical trials in small populations has triggered thinking regarding the most appropriate design methods for a particular clinical research question. Decision schemes and algorithms have been proposed, with varying starting points and foci. Parmar et al. (BMC Medicine 14:183, 2016) proposed a framework designed to assist the clinical trial team in design choices during protocol preparation. Herein, further stimulus is given regarding the extent to which a framework may help change practice for the better, the careful considerations for changing the usual error levels applied and the room for innovation in clinical trial design.Please see related article: http://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-016-0722-3.

【 授权许可】

CC BY   
© The Author(s). 2016