Regulations on Adaptive Design Clinical Trials

In recent years, adaptive designs have recaptured attentions in the clinical research society as they can improve the flexibility and efficiency of conducting a clinical trial and increase the chance of trial success. However, adaptive trials are complex to design and often accompanied with various degrees of statistical, procedural, logistic and regulatory challenges. This article provides a general overview of adaptive designs with attentions to the discussion on the basic concepts, classification, application scope and principles with current understanding of regulatory agencies throughout the article. The adaptive designs in the exploratory, seamless and confirmatory stages are separated discussed with some common types briefly described respectively in order to account for the differences in regulatory impact and concerns. The strategic regulatory, statistical and operational considerations on how to use adaptive design are presented. It is hopeful that more innovation and collaboration made by the industry, academia, and regulatory agencies could promote the application of adaptive designs and transform the drug development. *Corresponding author: Yuanxin Rong, Medical Director Global Medical and Regulatory Affairs, Bracco Diagnostics Inc. 259 Prospect Plains Road, Bldg. H Monroe Township, NJ 08831, USA, Tel: 1-609-514-2255; E-mail: [email protected] Received September 16, 2013; Accepted February 20, 2014; Published March 04, 2014 Citation: Rong Y (2014) Regulations on Adaptive Design Clinical Trials. Pharmaceut Reg Affairs 3: 116. doi:10.4172/2167-7689.1000116 Copyright: © 2014 Rong Y. 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.