The history, rationale, structure and function of DMCs is described.
Examples of DMC activity from actual completed trials are shared, illustrating the challenges of determining early interim evidence for benefit, potential harm or futility or other possible complications.
Some statistical methods such as group sequential and conditional power are described as used to monitor accumulating data for evidence of benefit, potential harm or futility.
The history, rationale, structure and function of a DMC are described using examples to illustrate the key issues.
DMC Reports must be prepared and presented to the DMC for their review. Recommendations for preparation and structure are shared to allow for effective and efficient DMC review.
Over the past 5 decades of DMC experience, many lessons have been learned and captured into best DMC practices or principles.
Lecture IV: Dave DeMets (1:06:32) (PowerPoint Slides)
This is the FDA lecture on useful statistical methods for interim monitoring of accumulating data for early evidence of convincing benefit, potential harm or trial futility.
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Lecture V: Stuart Pocock (0:41:17)
This lecture gives a brief overview of common statistical methods for interim analyses but focuses mostly on DMC scenarios that were challenging or instructive for the DMC.
The following are commentaries by leading clinicians experienced in DMCs as a member or as a DMC chair. They share what they have experienced that make DMC participation a valuable and rewarding service.
|5.1||Barry Davis, MD/PhD||University of Texas School of Public Health||Video (0:22:27)|
|5.2||Chris Granger, MD||Duke University||Video (0:36:17)|
|5.3||Charles Hennekens, MD/DPH||Florida Atlantic University||Video (0:27:41)|
|5.4||Jean Rouleau, MD||Montreal Heart Institute||Video (0:29:44)|
|5.5||Peter Sandercock, MD||University of Edinburgh||Video (0:30:49)|
|5.6||Lew Smith, MD||Northwestern University||Video (0:28:40)|
|5.7||Richard Whitley, MD||University of Alabama||Video (0:13:40)|
These 4 clinicians, very experienced in DMCs as a member or chair, engaged in a conversation with Dave DeMets on issues they had while serving on a DMC and wanted to share. In addition, Dr. Rockhold has extensive DMC experience from many years in industry and now most recently at Duke University.
|5.8||William Kelly, MD||Thomas Jefferson University||Video (0:19:23)|
|5.9||Marc Pfeffer, MD/PhD||Harvard University||Video (0:31:54)|
|5.10||Peter Sandercock, MD||University of Edinburgh||Video (0:26:33)|
|5.11||Richard Whitley, MD||University of Alabama||Video (0:27:17)|
|5.12||Frank Rockhold, PhD||Duke University||Video (0:39:20)|