CBERs Experience With Adaptive Design Clinical Trials

We present an up-to-date summary of adaptive design proposals seen in CBER and provide an overview of our experiences. We share our concerns regarding the statistical issues and operational challenges raised during the review process for adaptive design trials. We also provide general recommendations for developing proposals for such trials. Our motivation in writing this paper was to encourage the best study design proposals to be submitted to CBER. Sometimes these can be adaptive, and sometimes a simpler design is most efficient.

Source: Therapeutic Innovation and Regulatory Science - February 22, 2016 Category: Drugs & Pharmacology Authors: Lin, M., Lee, S., Zhen, B., Scott, J., Horne, A., Solomon, G., Russek-Cohen, E. Tags: Product Development and Innovation Source Type: research