Clinical Trials, Meet Adaptive Design

Adaptive design (AD) clinical trials have become increasingly popular as they offer the ability to reduce the overall time and cost of running clinical trials. They improve patient safety by minimizing exposure to unsafe or non-efficacious treatments. With its 2019 final guidance on Adaptive Design Clinical Trials for Drugs and Biologics, the U.S. Food & Drug Administration’s (FDA’s) position on adaptive designs for clinical trials is favorable.

The FDA encourages companies to consider utilizing adaptive designs to expedite and improve efficiencies for identifying the clinical benefit of new therapies. The European Medicines Agency (EMA) has also supported the adaptive pathways. Veristat is a pioneering leader in planning and executing adaptive design studies – delivering the expertise to determine the appropriate applications for adaptive designs, selecting and simulating the right design, and providing the operational expertise to execute the design with successful outcomes. Overall, Veristat’s goal is to help expedite decision-making for more efficient clinical trials.