Expert Opinion: Navigating the FDA Pilot Program in Oncology Drugs with In Vitro Diagnostic Tests: The Role of Real-World Data
The landscape of oncology research and development is constantly evolving, with breakthroughs in both diagnostic (Dx) and therapeutic (Rx) advancements. One recent development that holds tremendous potential to revolutionize concurrent Dx and Rx development is the new Oncology Drug Products with In Vitro Diagnostic Tests pilot program introduced by the U.S. Food and Drug Administration (FDA). This new pilot program requires testing performance criteria to be published based on the collection of data from labs using FDA provided templates. Our Chief Precision Medicine Officer, Susanne Munksted, in her thought-provoking blog post, 'Will FDA's newly launched 'Minimum Characteristics Pilot Program' drive LDTs to be the answer to better testing in precision medicine?' delved into the various questions and potential challenges that must be addressed within the pilot program, particularly in the context of drug manufacturers seeking to bring their products to market.
Today, we aim to shed light on the critical role real-world data (RWD) plays for drug manufacturers considering participation in the pilot program and the subsequent commercialization of their assets, especially in the established biomarker setting (not novel). We’ll focus on specific RWD elements that we believe will play an important role for manufacturers navigating the pilot program.