White Paper

The Promise And Challenge Of Adaptive Design In Oncology Trials

Source: Medpace

By Lyon L. Gleich

X-people

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.