On Statistical Principles for Clinical Trials in Pharmaceutical Development-A Review of China FDA Draft GuidanceShein-Chung Chow1, Zinan Chen1 and Fuyu Song2*
- *Corresponding Author:
- Fuyu Song
M.S., Peking University
Clinical Research Institute Peking University Health Science Center
No. 38 Xueyuan Road, Haidian District, Beijing, 100191, China
Tel: 110 402 430 047
E-mail: [email protected]
Received date: September 01, 2015 Accepted date: September 29, 2015 Published date: September 30, 2015
Citation: Chow SC, Chen Z, SongF (2015) On Statistical Principles for Clinical Trials in Pharmaceutical Development – A Review of China FDA Draft Guidance. Pharmaceut Reg Affairs 4:152. doi:10.4172/2167-7689.1000152
Copyright: © 2015 Chow SC, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
On August 21, 2015, the Center for Drug Evaluation (CDE) of China Food and Drug Administration (CFDA) circulated draft guidance on Statistical Principles for Clinical Trials in Pharmaceutical Development for public comments. The draft guidance is to assist the sponsor for providing accurate and reliable assessment of a test treatment under investigation in China. The draft guidance focuses on study designs, basic considerations for on-going trials, data management, and statistical principles for data analysis and reporting. In this article, we intend to comment on the draft guidance and provide constructive input and recommendations whenever possible.