When: December 4th, 2019 from 8 AM to 10 AM
Where: MassBio, 300 Technology Square, 8th Floor, Cambridge, MA 02139
CAMBRIDGE, MA, December 4, 2019 – This event featured a panel of industry leaders, and was moderated by PROMETRIKA’s own Miganush Stepanians, Ph.D., President and CEO.
Clinical trials are performed at specialized sites, with entry criteria that selects subjects likely to show efficacy but who are not necessarily representative of the broad population of patients. There is increasing concern on the part of regulators that explanatory clinical trials, which confirm a clinical hypothesis, tend to overestimate the effectiveness and underestimate the safety of medicinal products and devices. The use of real-world evidence to support regulatory decision making is discussed in the FDA final guidance for medical devices (2017) and draft guidance for drugs and biologics (2019). The guidances outline prospective pragmatic clinical trials (PCTs) and retrospective observational studies as the means to bridge the gap between explanatory trials and adoption evaluation. In this forum, our panel of experts will discuss the evolution and future of PCTs and observational studies as important tools for integration of real-world evidence in medical product development.
Learn more about closing the real-world evidence gap from the following panelists:
- Dr. Robert Califf, MD, MACC, Vice Chancellor for Clinical and Translational Research, Duke University
- Jane Liang White, ScD, Senior Director, Statistical Group Lead for Oncology Hematology Franchise, Pfizer
- Rebecca Miksad, MD, Senior Medical Director, Flatiron Health
In case you missed it, below are both the recorded video and presentation slides: