Online Program

Adaptive Designs: From the Past to the Current, and Future Directions (303492)

*Pourab Roy, US Food and Drug Administration 

Keywords: adaptive design, FDA guidance

Adaptive clinical trial designs have received significant attention in the last few decades both in academic and regulatory settings. There has been an increased interest in using adaptive clinical trials in modern drug development. These designs have the benefit of creating more efficient trials with optimized treatment assignments, can combine multiple stages into a seamless design and can enable better allocation of operational resources when combining multiple indications or compounds into a single master protocol. However, there are some challenges around the use of adaptive designs due to the their complexity. FDA issued their first guidance in 2010 and released two more guidance documents for adaptive designs and complex innovative designs in 2019. In this presentation we will highlight some of the important features of these guidances along with a few examples of successful adaptive designs reviewed by the Oncology Division of the FDA.