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Data Safety and Monitoring Boards

List of authors.
  • Arthur S. Slutsky, M.D.,
  • and James V. Lavery, Ph.D.

Data safety and monitoring boards are part of many clinical trials. This Sounding Board article addresses the ethical issues facing board members when they make a decision to stop a clinical trial early or to continue it in the face of evidence that one treatment is more effective than another.

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Funding and Disclosures

Dr. Slutsky reports that he currently chairs two data safety and monitoring boards, one for a trial of surfactant for patients with acute lung injury (sponsored by Leo Pharmaceuticals) and the other for two trials of bronchial thermoplasty for the treatment of chronic asthma (sponsored by Asthmatx [formerly Broncus]) and is a member of two other boards, one for trials conducted by the Acute Respiratory Distress Syndrome Network investigators, examining various treatment options for acute lung injury (sponsored by the National Institutes of Health), and the other for a trial examining the efficacy of vasopressin in the treatment of septic shock (sponsored by the Canadian Institutes of Health Research). Dr. Lavery reports that he is a member of the data safety and monitoring board for the current phase 3 trial of a vaccine against human immunodeficiency virus type 1 (Aventis Pasteur and VaxGen) in Thailand, sponsored by the U.S. government.

Author Affiliations

From the Departments of Medicine and Critical Care (A.S.S.) and the Center for Global Health Research and Inner City Health Research Unit (J.V.L.), St. Michael's Hospital; and the Departments of Medicine, Surgery, and Biomedical Engineering (A.S.S.) and the Department of Public Health Sciences and the Joint Centre for Bioethics (J.V.L.), University of Toronto — both in Toronto.

Address reprint requests to Dr. Slutsky at St. Michael's Hospital, Queen Wing, Rm. 4-042, 30 Bond St., Toronto, ON M5B 1W8, Canada, or at .

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