The recent 21st Century Cures Act, and subsequent comments by FDA Commissioner Scott Gottlieb, point out a number of reasons why adaptive trial designs make sense in the current pharmaceutical environment. In a speech to Congress, Gottlieb cited how “..new tools like flexible trial designs could make the [FDA] agency’s review more efficient,” and how adaptive trials could incentivize new treatments for pediatric cancer. This is all relevant to modernizing the ways that clinical information is collected and how the FDA is in support of new tools and clinical trial designs.
Challenges with Adaptive Trials
In fact, while adaptive trials have been around for quite some time, only about 20% of clinical trials are using adaptive designs, according to a study by the Tufts Center for the Study of Drug Development (CSDD). Some of the key issues in executing an adaptive trial design can include: