While Waiting for the FDA’s Adaptive Clinical Trials Workshop….

J0289439 Ever since Dr. Scott Gottlieb’s speech on adaptive clinical trials, and my posting on that topic, I have sensed an extraordinary amount of interest in the upcoming FDA workshop and in the topic itself, particularly from pharmaceutical companies.  The FDA has not yet posted information related to the workshop, but as soon as there is news, I will post it here as well.

In the meantime, if you are looking to get some valuable insight along these lines, I want to refer you to the July issue of Pharmaceutical Executive which carried a very valuable article from Derek Lowe, author of the excellent blog In the Pipeline

The article is entitled "What You Need to Know About Adaptive Trials" and Dr. Lowe offers insights into how many failed drug trials today might be saved, thereby increasing the efficiency of the pipeline through adaptive trials.  This article is an excellent tutorial on what is covered by adaptive clinical trials as well as providing an overview of their type and potential impact and information on the Bayesian statistical framework.  It is an area that promises many challenges, not only for researchers and companies, but for health policy leaders as well.  However, the potential for success from this paradigm shift, is something he makes apparent. 

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