Society for Clinical Trials Data Monitoring Committee Training Initiative

1 Introduction by Dave DeMets

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

Introduction: Word document (docx) summary of the video

Introduction: PowerPoint presentation used in the video

2 Neaton and DeMets DMC Video

2.1 Lecture I: DMC Structure and Function

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

2.2 Lecture II: DMC Statistical Tools

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

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

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

3.2 Lecture II: Tom Fleming, PhD ‐ DMC Best Practices

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

3.3 Lecture III: Janet Wittes, PhD ‐ Independent Statistician and DMC Reports

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.

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: Dave DeMets, PhD ‐ Statistical Methods for DMCs

5 DMC Clinician Experiences (each video approximately 30 minute)

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/PhD	University of Texas School of Public Health
5.2	Chris Granger, MD	Duke University
5.3	Charles Hennekens, MD/DPH	Florida Atlantic University
5.4	Jean Rouleau, MD	Montreal Heart Institute
5.5	Peter Sandercock, MD	University of Edinburgh
5.6	Lew Smith, MD	Northwestern University
5.7	Richard Whitley, MD	University of Alabama

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, MD	Thomas Jefferson University
5.9	Marc Pfeffer, MD/PhD	Harvard University
5.10	Peter Sandercock, MD	University of Edinburgh
5.11	Richard Whitley, MD	University of Alabama