Adaptive Design Practice at the Center for Devices and Radiological Health (CDRH), January 2007 to May 2013

Adaptive designs have generated great interest in the clinical trial community as a result of their versatility and efficiency. Recently, the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) surveyed all adaptive design applications submitted between 2007 and May 2013 for regulatory review. In this paper, we discuss the overall results and findings that emerged from an in-depth examination of the submissions. We summarize the current status of adaptive designs used in medical device studies. We also identify some of the lessons learned and common pitfalls that we encountered in our review of the designs.

Source: Therapeutic Innovation and Regulatory Science - October 23, 2016 Category: Drugs & Pharmacology Authors: Yang, X., Thompson, L., Chu, J., Liu, S., Lu, H., Zhou, J., Gomatam, S., Tang, R., Zhao, Y., Ge, Y., Gray, G. W. Tags: Regulatory Science Source Type: research