The Essential Madison Bibliography

These four texts, authored or co-authored by Dave DeMets, form the foundation of the “Madison School” of clinical trial oversight.

1. The “Intro” - Fundamentals of Clinical Trials (5th Ed)

Friedman, Furberg, and DeMets (2015) - Role: The comprehensive primer. - DMC Utility: Excellent for the “Big Picture” of where the DMC fits into the broader trial ecosystem (Recruitment, Randomization, and Data Management).

2. The “Blue Book” - Data Monitoring Committees in Clinical Trials

Ellenberg, Fleming, and DeMets (2002) - Role: The practitioner’s handbook. - DMC Utility: This is the most important book for this project. It covers the “Firewall,” the Charter, and the specific dynamics of the Open vs. Closed sessions.

3. The “War Stories” - Data Monitoring in Clinical Trials: A Case Studies Approach

DeMets, Furberg, and Friedman (2006) - Role: Real-world application. - DMC Utility: Critical for learning from past DMCs (like CAST or BHAT). It helps statisticians understand that “the math is the easy part”—it’s the decision-making under uncertainty that is hard.

4. The “Math” - Introduction to Statistical Methods for Clinical Trials

Cook and DeMets (2008) - Role: The technical deep-dive. - DMC Utility: This is where the Group Sequential methods, alpha-spending functions, and survival analysis techniques are formalized.