The discussion session will include timely information from a panel of FDA representatives discussing the value of real-world evidence in the context of oncology clinical trials affected by the COVID-19 pandemic. The FDA representatives will be joined by Syapse President, Jonathan Hirsch, who will discuss the role of RWE in assisting with regulatory reform. "This pandemic presents real challenges to sponsors of clinical trials, in the context of the existing clinical research and regulatory framework," said Jonathan Hirsch. “We have the opportunity to address the impact of the COVID-19 pandemic on cancer drug development by partnering with regulators and the use of real-world evidence. The pandemic is pushing us to respond in a timely manner with responsibly."
The panel includes: Dr. Paul G. Kluetz, MD, Amy P. Abernethy, M.D., Ph.D., Wendy Rubinstein, MD, PhD. followed by a discussion session between the panelists and Jonathan Hirsch, moderated by Dr Harpreet Singh, MD.