This panel will consider the context for evidence, rather than the level of evidence, needed to move innovative technology into a clinical setting and how we will generate the needed evidence. Which evidence questions must be answered pre- market and which, if any, can be answered post-market? It will consider the often mismatched evidence requirements of patients, clinicians, test developers, regulators and payers. Collectively, we should define a burden of evidence that's appropriate for the balances of risk and speed that is appropriate in this space. This will require community-wide cooperation to collect and analyze data residing in many different places -- inside pharmaceutical companies, inside diagnostics companies and payers -- to measure outcomes and define the best use of diagnostics, and innovative methodologies to generate evidence (both in process and results).
Moderator: Adam Berger, Institute of Medicine
Patricia Deverka, Center for Medical Technology Policy
Stanley Lapidus, SynapDx
Susan Friedman, Facing Our Risk of Cancer Empowered
David Clifford, PatientsLikeMe
Roger Klein, University of South Florida Medical School.