Source (3/16)

Nelson, Nancy J. "Adaptive Clinical Trial Design: Has Its Time Come?" Journal of the National Cancer Institute. 102.16 (2010): 1217-1218. Electronic.

This relatively short article explained about the evolution of adaptive trials. It begins by describing BATTLE, one of the first adaptive design phase II clinical trial. Since then, it has been proven that adaptive designs can work in a "complex trial that assessed multiple drugs and biomarkers and required tissue collection and biomarker analysis." Though there were only 3 or fewer adaptive design studies started per year between 2003 and 2006, in 2007 there were 13, and the numbers are continuing to rise. This rise is perhaps due to the "growing acceptance of the Bayesian statistical framework" which, 10 years ago, was never accepted by the FDA as a valid design analysis.  


Unfortunately, "adaptive trials are great for learning, but are not a panacea." Adaptive designs take an extra 3 months to plan and involve everyone with even an interest in the process. Also, the design demands "an infrastructure to facilitate real-time learning, a flexible drug supply, and frequent data intake." On top of all that, not very many have extensive training in Bayesian theory. There just is not a "big enough sample size to get a definitive result." 


Enter computer simulations, which I will be researching next.