We are all trying to re-enter the workforce after August. Here in the Beltway, the Congress is headed back and the traffic congestion returns as students everywhere return to school. Labor Day Weekend has passed and alas, I have put away the white bucks and seersucker suits until next Memorial Day.
While I took a brief hiatus at the end of August, it was not because I was enjoying a well-deserved vacation, but actuallydue to the fact that I was just so darned busy. Nevertheless, I did manage to steal a little time to record a podcast with Janet Woodcock, M.D., Deputy Commissioner and Chief Medical Officer at the FDA. Recently, she authored a commentary on the Critical Path Initiative at FDA that was published August 17. I, once again, had adaptive clinical trials on my mind, and thought it a good time to ask about the future role of adaptive clinical trials and she agreed to give me the time.
By way of background, very simply put, adaptive clinical trials are a research design that allows you to change the clinical trial to reflect learnings you may make along the way. Dr. Woodcock and I covered where they are in their evolution and where the FDA is in terms of working with companies that want to employ adaptive trials.
I have not posted a podcast all summer. I miss it! I hope you enjoy this one.
For other interesting information on adaptive clinical trials by some smart folks, see Derek Lowe’s "What You Need to Know About Adaptive Clinical Trials" – a piece in Pharmaceutical Executive, published in July, 2006. Also, you may want to take a look at an adaptive clinical trials speech by Dr. Scott Gottlieb while he was still at FDA.