The History of Data Monitoring Committees

A look into the evolution and history of data monitoring committees, from the 1960s to today.

Introduction: The University Group Diabetes Program

In the early 1960s a group of 26 people came together as part of a “treatment effects monitoring” committee involved in a controversial type II diabetes study which previously had been surrounded by concerns regarding drug safety and inadequate monitoring. The study was large, involving over 1,000 subjects and spanning 12 different clinics.

Every six months, the treatment effects monitoring committee met to review reports generated by the study’s coordinating center. The introduction of this interim monitoring led to two instances when protocol changes were voted on with a simple majority over the course of the approximately 10 year program.

This treatment effects monitoring committee was one of the earliest versions of a data monitoring committee (DMC), though it was not independent from the study in the same way that DMCs are today.

Independence is Key: The “Greenburg Report”

An expert committee headed by Dr. Bernard Greenburg, a statistician from the University of North Carolina, created the “Greenburg Report” in 1967, calling for an independent committee for interim monitoring.

The report discussed the management of complex multi-institutional clinical trials and suggested the need for an “independent advisory committee” to help manage them. The Greenburg Report was never intended for publication and was instead delivered as a set of recommendations to the then-National Heart Institute. Today, after over 50 years, much of what the Greenburg Report discussed is still relevant to the challenges of complex multi-institutional trials.

DMCs Today

Nowadays, independent data monitoring committees –also known as DMCs, IDMCs, or DSMBs – are widely used to monitor participant safety and study drug efficacy.

There are several factors that determine whether a DMC is needed, including the trial design and population. Verifying the need for a DMC can be distilled to three major questions:

  • Could a DMC help lessen patient risk?
  • Is DMC review practical (e.g., is the trial long enough to be able to have review during the study)?
  • Will a DMC help assure scientific validity?

Since the early 2000s, there has been a notable shift from the use of DMCs primarily in government sponsored clinical trials to both government and industry sponsored trials. This change can be attributed to several factors that include:

  • Growing number of industry sponsored trials with major morbidity endpoints;
  • Increasing collaboration between industry and government in sponsoring clinical trials;
  • Heightened awareness of clinical trial conduct and analysis concerns within the scientific community;
  • Institutional Review Board (IRB) concerns regarding monitoring and safety in multicenter trials.

History of Data Monitoring Committees: Conclusion

In the over 50 years since DMCs were first introduced, they have grown in popularity and continue to help make clinical trials safe for patients. However, as they’ve grown in popularity, they’ve also grown in complexity and administrative burden.

PharPoint Research has over a decade of experience with DMCs, including the administrative support of committees and the delivery of analyses. For more information about how our team may be able to assist with DMC services for your upcoming clinical trial, contact our business development team.