Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes
The U.S. Food and Drug Administration (FDA) is announcing the following public workshop entitled “Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes.” Convened by Duke University’s Robert J. Margolis, MD, Center for Health Policy (Duke Margolis) and supported by a cooperative agreement with FDA, the purpose of the public workshop is to bring the stakeholder community together to explore key considerations for using randomized designs, such as large simple trials or those that incorporate pragmatic elements to generate real-world evidence (RWE).
The workshop will explore key considerations for using randomized clinical trial designs and real-world data (RWD) to generate RWE, particularly in clinical care settings. Considerations for discussion include: (1) selection of interventions appropriate in clinical care settings, (2) study design elements and study populations, (3) capturing outcomes in clinical care settings, and (4) addressing potential challenges around blinding, randomization, and bias. The workshop will also explore regulatory considerations for randomized clinical trials using RWD, such as safety and product monitoring and maintaining data integrity.
Docket No.: FDA-2019-N-0001
Date and Location: The public workshop will be held on July 11, 2019, from 8:30 a.m. to 5 p.m., Eastern Time and July 12, 2019, from 9 a.m. to 1 p.m., Eastern Time at The Westin City Center, 1400 M St NW, Washington, DC 20005.
Registration: For registration and additional travel information, please refer to the Duke Margolis Center for Health Policy website.