The US Food and Drug Administration (FDA) has signaled that relying on a single pivotal trial, rather than two, may become a more commonly acceptable pathway to market authorization. There are significant benefits for sponsors, potentially reducing the cost and complexity of running two trials as well as time to market, which puts lifesaving treatments in the hands of patients sooner. Knowing if a single pivotal trial is optimal strategy for your program is key. This playbook explores how sponsors can adapt clinical development strategies for this new era in FDA guidance. The appropriate due diligence is critical to ensuring the Agency will agree to a single trial. You’ll learn: How to gauge whether a single pivotal trial is appropriate and feasible for your program. Best practices to devise scientifically sound single pivotal trials that stand up to regulatory scrutiny. How to find the support you need to align with the FDA early to select the best path to market.
