Challenges and opportunities in using real-world evidence to support the approval of companion diagnostics in the era of precision medicine: an interview with Brian Clancy, Foundation Medicine

As precision medicine and genomic testing to improve cancer care evolves, stakeholders are recognizing the growing importance of real-world data and evidence (RWD/RWE) to support the approval of companion diagnostics (CDx). However, there is no one-size-fits-all approach to defining fit-for-purpose RWE in regulatory decision making for companion diagnostics and many factors need to be considered. In this interview, Brian Clancy, Director, Real-World Data Solutions at Foundation Medicine explores the use of RWE in the approval of CDx and provides his thoughts on the evolving role of RWE to complement traditional evidence generation in precision medicine. Please could you introduce yourself...