According to the FDA, real-world data (RWD) and real-world evidence (RWE) are playing an increasing role in health care decisions. Computers, wearables, mobile devices, and biosensors are all enabling researchers to gather and store large amounts of health-related data. For drug developers, RWD and RWE are being used to support clinical trial designs and observational studies to generate new treatment approaches. But how exactly is this information being used by regulators and sponsor companies? And what will it mean to the future of drug development?
In August 2021, I had the opportunity to sit down with three experts to discuss this topic. In this segment, Christoph Koenen of Otsuka and Gregg Sylvester of Seqirus discuss how RWE and RWD could lead to the greater use of synthetic control arms in clinical studies.