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Incorporating Patient Input into the Design and Conduct of Clinical Trials
Session Chair(s)
Meghana Chalasani, MHA
Lead, Advisory Committees, Office of New Drugs, CDER
FDA, United States
This forum will outline efforts, best practices, and key considerations to enhance the incorporation of patient input into the design and conduct of clinical trials.
Learning Objective : Outline current efforts and opportunities to incorporate patient input into the design and conduct of clinical trials (CT); Discuss approaches, best practices, and key considerations to facilitate patient recruitment, enrollment and retention, and minimize the burden of patient participation in CTs; Identify opportunities to enhance patient engagement and ensure patient input informs CTs.
Speaker(s)
Panelist
Alexis Miller, JD
Merck & Co., Inc., United States
Acting Global Lead, Global Regulatory Policy and Intelligence
Panelist
Michelle Tarver, MD, PhD
FDA, United States
Deputy Center Director for Transformation, CDRH
Panelist
Marilena Flouri, PhD
FDA, United States
Mathematical Statistician, OTS, CDER
Panelist
Mary Elmer, BSN, MSN, RN
Merck & Co., Inc., United States
Executive Director, Patient Engagement for Oncology
Panelist
T.J. Sharpe, PMP
Medidata Solutions, United States
Patient Engagement Program Manager
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