title: An opinion and practice survey on the structure and management of data and safety monitoring boards.
abstract: There is little to no empirical data available on how data and safety monitoring boards (DSMBs) are structured and how they operate. The purpose of this study was to provide data on this. To accomplish this goal, we administered a random survey on current structure and management practices and opinions as reported by principal investigators (PIs) and biostatisticians. We also surveyed Institutional Review Board (IRB) community members, as proxies for the public, as to their opinions on how DSMBs should be structured and managed. A final purpose was to compare opinions about what should be taking place to what is actually happening.
authors.affiliation: Program in Ethics and Policy, Center for Biomedical Ethics and Humanities, University of Virginia School of Medicine, Charlottesville, Virginia 22908, USA. pjm7s@virginia.edu
authors.forename: Patti M
authors.initials: PM
authors.lastname: Tereskerz
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Guterbock
authors.forename: Deborah A
authors.initials: DA
authors.lastname: Kermer
authors.forename: Jonathan D
authors.initials: JD
authors.lastname: Moreno
mesh_terms: D035843:Biomedical Research; D026661:Clinical Trials Data Monitoring Committees / Q000941:ethics / Q000458:organization & administration* / Q000706:statistics & numerical data; D003625:Data Collection; D028744:Ethics Committees, Research / Q000941:ethics / Q000458:organization & administration* / Q000706:statistics & numerical data; D005104:Expert Testimony; D005260:Female; D006801:Humans; D008297:Male; D010818:Practice Patterns, Physicians' / Q000706:statistics & numerical data*; D011795:Surveys and Questionnaires; D014481:United States