Breakout Sessions : Re-Imagining Clinical Trials: Ideas and Early Feedback on New Trial Designs

jun 6, 2019: 9 a.m. - 10:15 a.m.
105AB, Level 100

As discovery and development of cancer drugs continues to explode, cost pressures continue to mount and the number of investigators and patients are finite. The biopharmaceutical industry, together with relevant stakeholders, must design and implement non-traditional clinical trials. This session will discuss specific examples of innovative trial designs, pulling from the experience of biopharma, investigators and patients, and seek feedback from the FDA on the feasibility and practicality of atypical trial designs being the basis for New Drug Applications.

Speakers

Amy McKee
Acting Deputy Office D...

Mark Stewart
Vice President, Scienc...

Donald Berry
Professor