Adaptive Designs: Results of 2016 Survey on Perception and Use.

The most common types of ADs remain early stopping, treatment group adaptations, and sample size re-estimation. Both stopping early for safety and changing the endpoint of the analyses were rarely mentioned in literature prior to 2012 but are now appearing more frequently. The barriers of change management and negative experiences by some institutions with ADs remain a source of concern. Additional, consistent training would be helpful to choose the right adaptation(s) needed for specific clinical trials and for planning appropriately for operational efficiency such as for drug supply management and data management. The perceived barrier of regulatory acceptance also remains a concern, which could be alleviated by additional interaction with agencies and an update of the FDA draft guidance to industry on adaptive designs.