In the world of drug development, clinical issues and statistical issues cannot be separated. All are scientific and all use applied logic. However, safety monitoring in pharmaceutical industry clinical trials through data monitoring committees (DMCs) is both an art and a science, requiring the use of sound judgment as well as sound scientific method.
In Data and Safety Monitoring Committees in Clinical Trials, Jay Herson applies his years of experience serving on and providing statistical support to DMCs. He reviews the current state of DMCs and the best practices that have evolved using the same lively approach he employed when writing Herson’s Handout for the ALA newsletter Under the Curve, 1991–2004.
Defining the stewardship role and inner workings of DMCs, Dr. Herson —
Describes a DMC’s interactions with sponsors, data analysis centers, institutional review boards, and regulatory agencies
Examines the biases and pitfalls in analyzing safety data, as well as other clinical issues including the distinction between adverse events, serious adverse events, and severe adverse events
Presents those statistical methods useful for DMCs, illustrated with data from actual clinical trials
Demonstrates how physicians think differently about safety data than statisticians, and explains why both views are needed
With regulatory agencies worldwide now facing considerable challenges, it is important that those involved with trials review the direction and effectiveness of DMCs. Providing a perspective that few can match, Dr. Herson fully explains the types of decisions DMCs are called upon to make as well as the environment in which they are made, taking into consideration the cultural, political, and clinical issues that require the use of good sense along with good science.
About the Author
Jay Herson is a professor at Johns Hopkins University in Baltimore, Jay Herson. During the past 30 years he has developed methods for design and analysis of clinical trials with planned interim analyses and sample size re-estimation. He organized and chaired the first data monitoring committee in the pharmaceutical industry and helped the FDA draft a guidance document on data monitoring committees.