Pharmaceutical Regulatory Affairs: Open Access

On Statistical Principles for Clinical Trials in Pharmaceutical Development – A Review of China FDA Draft Guidance

Abstract

Shein-Chung Chow, Fuyu Song and Zinan Chen

On August 21, 2015, the Center for Drug Evaluation (CDE) of China Food and Drug Administration (CFDA) circulated draft guidance on Statistical Principles for Clinical Trials in Pharmaceutical Development for public comments. The draft guidance is to assist the sponsor for providing accurate and reliable assessment of a test treatment under investigation in China. The draft guidance focuses on study designs, basic considerations for on-going trials, data management, and statistical principles for data analysis and reporting. In this article, we intend to comment on the draft guidance and provide constructive input and recommendations whenever possible.