Training the Next Generation of Data Monitoring Committee Members: An Initiative of the Heart Failure Collaboratory

Thomas R Fleming; Janet Wittes; Mona Fiuzat; Michael R Bristow; Frank W Rockhold; Jason T Connor; Benjamin R Saville; Brian Claggett; Isabella Cavagna; William T Abraham; Thomas D Cook; JoAnn Lindenfeld; Christopher O'Connor; David L DeMets; Heart Failure Collaboratory

doi:10.1016/j.jchf.2024.02.016

Training the Next Generation of Data Monitoring Committee Members: An Initiative of the Heart Failure Collaboratory

JACC Heart Fail. 2024 Mar 23:S2213-1779(24)00180-X. doi: 10.1016/j.jchf.2024.02.016. Online ahead of print.

Authors

Affiliations

¹ Department of Biostatistics, University of Washington, Seattle, Washington, USA.
² Wittes LLC, Washington, DC, USA.
³ Division of Cardiology, Duke University, Durham, North Carolina, USA. Electronic address: mona.fiuzat@duke.edu.
⁴ Division of Cardiology, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
⁵ Department of Biostatistics and Bioinformatics, Duke University School of Medicine and Duke Clinical Research Institute, Durham, North Carolina, USA.
⁶ ConfluenceStat LLC, Cooper City, Florida, USA; University of Central Florida College of Medicine, Orlando, Florida, USA.
⁷ Adaptix Trials, LLC, Austin, Texas, USA; Vanderbilt University Department of Biostatistics (adjoint faculty), Nashville, Tennessee, USA.
⁸ Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.
⁹ Inova Schar Heart and Vascular, Fall Church, Virginia, USA.
¹⁰ Division of Cardiovascular Medicine and the Davis Heart and Lung Research Institute, The Ohio State University College of Medicine/Ohio State University Wexner Medical Center, Columbus, Ohio, USA.
¹¹ Biostatistics and Medical Informatics, University of Wisconsin, Madison, Wisconsin, USA.
¹² Division of Cardiovascular Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
¹³ Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison, Wisconsin, USA.

PMID: 38530701
DOI: 10.1016/j.jchf.2024.02.016

Abstract

Clinical trials are vital for assessing therapeutic interventions. The associated data monitoring committees (DMCs) safeguard patient interests and enhance trial integrity, thus promoting timely, reliable evaluations of those interventions. We face an urgent need to recruit and train new DMC members. The Heart Failure Collaboratory (HFC), a multidisciplinary public-private consortium of academics, trialists, patients, industry representatives, and government agencies, is working to improve the clinical trial ecosystem. The HFC aims to improve clinical trial efficiency and quality by standardizing concepts, and to help meet the demand for experienced individuals on DMCs by creating a standardized approach to training new members. This paper discusses the HFC's training workshop, and an apprenticeship model for new DMC members. It describes opportunities and challenges DMCs face, along with common myths and best practices learned through previous experiences, with an emphasis on data confidentiality and need for quality independent statistical reporting groups.

Keywords: data monitoring committees; heart failure; statistics; training.

Publication types

Review