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 Statistical Tools (1:43:39)

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.

2.3 Lecture III:  DMC Case Studies (1:17:45)

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.

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   FDA CDER DMC Workshop

Lectures 3.1, 3.2 and 3.2 above are variations of lectures presented at the FDA CDER. Lecture 4.1 presented here 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.

4.1 Lecture IV:  Statistical Methods for DMCs

Lecture IV: Dave DeMets (1:06:32) (PowerPoint Slides)

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5   DMC Clinician Experiences (each video approximately 30 minutes)

DMC COMMENTARIES

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)

DMC CONVERSATIONS with Dave DeMets

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.

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)