“Reveal-ution” in Clinical Trials
“I’m a big proponent of starting all over and doing it right,” … how many individuals, experts, thought leaders, visionaries, policymakers, strategy designers, have explicitly or implicitly made this statement? In how many disciplines? We live in an era of chaos, in which many realms of existence are manifesting fundamental paradigm shifts. Clinical Trails is one of them. The continuation of the opening sentence above is {“[…]” Woosley says. “Randomized controlled trials are out of date, and it’s time to use the tools of the future.”}. The founder of The Critical Path Institute founder’s, Dr. Ray Woosley, clear statements capture the current status of the clinical trial process in a beautifully written article by Malorye Allison in last month’s issue of Nature Biotechnology. (1)
2012 will bring substantial changes to the conduct of clinical studies. And a critical component of such revolution is what I like to conceptualize as a “reveal-ution”, a process by which everything is revealed. In her Nature Biotechnology piece Ms. Allison offers a frame for naming what has not been working and calls for change, as well as novel approaches that are gaining traction.
Many key voices in the field are already discussing and implementing new paradigms: modeling and simulation methodologies, adaptive designs, seamless designs, sample size re-estimation methods, electronic data capture, precompetitive data sharing, virtual trials, regulatory evolution, market-access-minded clinical development … infinite possibilities start to be revealed. However, are we ready, do we know how to integrate them in a coherent and efficient manner? A revealing piece of data is that of 108 failed phase 2 trials in 2008 to 2010, almost 30% were related to strategy, or as the author refers to they were “strategy bombs”. (2)
In a series of upcoming blog posts, we intend to offer a forum for discussion of “must-have” strategies for an efficient revolution in clinical trials. We hope you choose to participate.
(1) Allison, M. Reinventing clinical trials. Nat. Biotech. 30 (1): 41-49 (2012).
(2) Arrowsmith, J. Phase II failures: 2008–2010. Nat. Rev. Drug Discov. 10: 328–329 (2011).