Society for Clinical Trials Data Monitoring Committee Training Initiative

1   Introduction by Dave DeMets

DMC Training Video:  DMC Training Zoom Video (mp4) (14:20)

DMC Training Text:  DMC Training Word document (docx) summary of the video

DMC Training PowerPoint Slides:  PowerPoint presentation used in the video (pptx)

2   Neaton - DeMets DMC Video Lectures

2.1 Lecture I:  DMC Structure and Function (1:34:17)

The history, rationale, structure and function of DMCs is described.

2.2 Lecture II:  DMC Case Studies (1:43:39)

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.

2.3 Lecture III:  DMC Statistical Tools (1:17:45)

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.

3   Seattle 2020 Symposium on DMCs

3.1 Lecture I:  Susan Ellenberg, PhD ‐ DMC Structure and Function (1:59:20) (PowerPoint Slides)

The history, rationale, structure and function of a DMC are described using examples to illustrate the key issues.

3.2 Lecture II:  Janet Wittes, PhD ‐ Independent Statistician and DMC Reports (2:32:52) (PowerPoint Slides)

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.

3.3 Lecture III:  Tom Fleming, PhD ‐ DMC Best Practices (2:42:31) 

Over the past 5 decades of DMC experience, many lessons have been learned and captured into best DMC practices or principles.

4   Additional Lectures

Lecture 4.1:  Dave DeMets, PhD - Statistical Methods for DMCs

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 4.2:  Stuart Pocock, PhD - DMC Scenarios

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.

5   DMC Clinician Experiences (each video approximately 30 minutes)


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/PhDUniversity of Texas School of Public Health    Video (0:22:27)
5.2    Chris Granger, MDDuke University    Video (0:36:17)
5.3    Charles Hennekens, MD/DPH    Florida Atlantic University    Video (0:27:41)
5.4    Jean Rouleau, MDMontreal Heart Institute    Video (0:29:44)
5.5    Peter Sandercock, MDUniversity of Edinburgh    Video (0:30:49)
5.6    Lew Smith, MDNorthwestern University    Video (0:28:40)
5.7    Richard Whitley, MDUniversity 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, MDThomas Jefferson University                             Video (0:19:23)
5.9    Marc Pfeffer, MD/PhD               Harvard University                             Video (0:31:54)
5.10   Peter Sandercock, MDUniversity of Edinburgh                             Video (0:26:33)
5.11   Richard Whitley, MDUniversity of Alabama                             Video (0:27:17)
5.12   Frank Rockhold, PhDDuke University                             Video (0:39:20)