Adaptive Designs Save Time And Money: Why Aren't They Used More Often?

As modern clinical trials grow increasingly complex, it comes as no surprise that the industry has increased interest in flexible trial designs—such as adaptive ones—that can potentially expedite trials’ timeline and enhance the likelihood that it will answer the question it was designed to address.

This includes stopping a trial early for futility, which can be viewed as a success because the research question has presumably been answered; resources can then be reallocated to more promising programs (Bothwell, 2018; Hummell, 2015).

The possible outcomes of adaptive trials benefit patients and sponsors alike, as their designs differ from traditional fixed-sample designs. They use accumulating data while the study is ongoing to make prespecified changes (i.e., adaptations) that may, for example, provide the flexibility to identify the clinical benefit of treatment during a trial, and then apply that information to patients enrolling in the trial without undermining its scientific validity and integrity (Madhavan, 2021; Chow, 2014; Menis, 2014; Berry, 2012; Gallo, 2006; Pallmann, 2018; Zang, 2014).

This white paper provides a brief introduction to adaptive designs, including their major benefits and challenges and best practices for operationalizing them. This foundation will help maximize the likelihood of success when implementing an adaptive trial design.