Real-World Evidence Webinar Series:
Integrating Randomized Controlled Trials for
Drug and Biological Products Into Routine Clinical Practice

Friday, November 22, 2024 | 1-1:45pm (eastern)

The Reagan-Udall Foundation for the FDA, in collaboration with the Food and Drug Administration (FDA), is hosting a public webinar as part of a series of webinars for FDA-issued guidance related to real-world evidence (RWE). This latest session in the webinar series will discuss the draft guidance: Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice.

The guidance document addresses randomized controlled trials (RCTs) that have been integrated within routine clinical practice. Such RCTs have streamlined protocols that focus on collection of essential data and are often referred to as point-of-care or large, simple trials. The guidance document discusses how leveraging established health care institutions can help reduce startup time and support trial enrollment. Involving local health care providers also offers convenience and accessibility to diverse patient populations who may not otherwise have the opportunity to participate.

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To ensure that the Agency considers comments before working on the final version of this guidance, electronic or written comments on the draft guidance may be submitted to the assigned docket by FDA-2024-D-2052 more information on submitting comments to the FDA is available here.

Agenda

1pm

Welcome

Susan C. Winckler, RPH, Esq., CEO, Reagan-Udall Foundation for the FDA

1:05pm

Opening Remarks

John Concato, MD, MS, MPH, Associate Director for Real-World Evidence Analytics, Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

1:10pm

Overview of Draft Guidance

Speakers:

  • Leonard Sacks, MBBCh, Associate Director, Clinical Methodologies, Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
  • Heather Stone, MPH, Health Science Policy Analyst, Clinical Methodologies, Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

1:25pm

Question and Answer

Moderator: Susan C. Winckler, RPh, Esq.

Panelists:

  • John Concato, MD, MS, MPH
  • Leonard Sacks, MBBCh
  • Heather Stone, MPH

1:40pm

Closing Remarks

Susan C. Winckler, RPh, Esq.

1:45pm

Adjourn

Funding Disclosure: This webinar is part of a series hosted by the Reagan-Udall Foundation for the FDA, in collaboration with the U.S. Food and Drug Administration (FDA). This series is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of an award of $75,417 in federal funds (100% of the project). The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA, HHS, or the U.S. Government. For more information, please visit FDA.gov.