CERSI Summit Attendees Discuss Barriers to Wider Real-World Evidence Adoption

At this years’ Innovations in Regulatory Science Summit, hosted by the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI), speakers talked about the hurdles faced in expanding the use of real-world evidence (RWE) and real-world data (RWD). Jeff Shuren of the FDA noted that collecting clinical evidence that meets regulatory standards will require a concerted effort by his and other federal agencies

According to Mathai Mammen of J&J, “Regulatory bodies have grown accustomed to certain endpoints as valid, but in this world of new diseases and rare diseases and revisiting old diseases, putting different boundaries around existing diseases, there’s an opportunity to draw more measurements in a clinical development program [and] try to match them with measurements that are actually made in the real world”

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(Source: RAPS, November 11^th, 2023)