Advarra The Mult-Regional Clinical Trials Center of Brigham & Women's Hospital and Harvard Medical School
Adaptive clinical trials modify key features of studies using pre-determined criteria and prospectively planned, periodic data analysis. The goal is to make a clinical trial that is flexible, efficient, and fast without compromising validity and integrity. Platform trials similarly alter designs in ways that allow for adaptation and testing of multiple therapies and potential for a shared control group. Ultimately, these designs are intended to reduce the number of patients assigned to ineffective therapies, to generate knowledge quickly, and to allow studies to evolve as knowledge accumulates. For many of these reasons, adaptive and platform trials have emerged as an effective trial design to test promising products in the COVID-19 crisis. However, adaptive designs and platform trials raise interesting ethical challenges related to informed consent, clinical equipoise, and justice. They are also very complex and raise important practical issues related to IRB oversight. This panel will explore these important ethical and practical advantages and challenges of adaptive and platform trials.