@article{7683bba104cc426f8e0623fc08fe85dd,
title = "Data and safety monitoring board deliberations resulting in the early termination of the Monoclonal Antibody Cytomegalovirus Retinitis Trial",
abstract = "We report on two features of the early termination of the Studies of Ocular Complications of AIDS Monoclonal Antibody Cytomegalovirus Retinitis Trial: one related to the deliberative process of the treatment effects monitoring body (the policy and data monitoring board [PDMB]) and the other related to the relationships among the PDMB, the investigators, and the joint sponsors (the National Institutes of Health and a pharmaceutical company). The PDMB was challenged with reconciling internally inconsistent safety and mortality data and determining the weight to give mortality data from other concurrently running trials. The coordinating center faced a challenge in negotiating how to communicate results from a jointly sponsored trial. Early resolution of certain organizational and procedural issues, such as rules regarding absentee voting, to which body the monitoring committee should report officially, and the timing and general content of dissemination of different kinds of results, would make jointly sponsored trials more robust to difficulties at the final hour.",
keywords = "AIDS, Cytomegalovirus retinitis, HIV, MSL-109, Monoclonal antibody, Randomized controlled clinical trial, Treatment effects monitoring committee",
author = "Gilpin, {Adele M.Kaplan} and Holbrook, {Janet T.} and Jabs, {Douglas A.} and Meinert, {Curtis L.}",
note = "Funding Information: Financial disclosure statements are on file at the SOCA Coordinating Center, The Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland. This work was supported by cooperative agreements from the National Eye Institute to the Johns Hopkins University School of Medicine (U10 EY 08052), Bloomberg School of Public Health (U10 EY 08057), and the University of Wisconsin School of Medicine (U10 EY 08067). Additional support was provided by National Center for Research Resources through General Clinical Research Center grants 5M01 RR 00350 (Baylor College of Medicine), 5M01 RR 05096 (Louisiana State University/Tulane), 5M01 RR 00096 (New York University), 5M01 RR 000865 (University of California, Los Angeles), and 5M01 RR 00046 (University of North Carolina). Support was also provided by the National Institute of Allergy and Infectious Diseases through cooperative agreements U01 AI 27668 (The Johns Hopkins University), U01 AI 27674 (Louisiana State University/Tulane), U01 AI 27669 (Memorial Sloan-Kettering), U01 AI 25917 (New York Hospital-Cornell Medical Center), U01 AI 27667 (Mount Sinai Medical Center), U01 AI 27665 (New York University), U01 AI 25915 (Northwestern University), U01 AI 27660 (University of California, Los Angeles), U01 AI 27670 (University of California, San Diego), U01 AI 27663 (University of California, San Francisco), U01AI25868 (University of North Carolina), and U01 AI27761 (University of Minnesota). Drug and additional support provided by Protein Design Laboratories, Inc. (Mountain View, California).",
year = "2003",
month = feb,
doi = "10.1016/S0197-2456(02)00268-4",
language = "English (US)",
volume = "24",
pages = "92--98",
journal = "Controlled clinical trials",
issn = "0197-2456",
publisher = "Elsevier BV",
number = "1",
}