By Lyon L. Gleich
Incorporating adaptive design methodologies into clinical trials can reduce costs and enhance efficiency while maintaining trial integrity. They can also reduce the number of patients on placebo and sub-therapeutic doses. In light of this promise, regulatory bodies have created guidelines supportive of adaptive design.
Despite their potential adaptive designs are currently used in only about 20% of clinical trials. Industry sponsors cite their lack of experience with the approach and a lack of experience on the part of the contract research organizations (CROs) with whom they partner as a key reason for this low adoption rate. To successfully implement an adaptive design model, sponsors must seek out research partners who have demonstrated experience in complex modeling; expertise in protocol design and statistical analysis, advanced technological capabilities and an in-depth understanding of the regulatory environment are essential.