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Previous Volume 350:1143-1147 March 11, 2004 Number 11 Next

	Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

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Data safety and monitoring boards, also known by other names (e.g., data monitoring committees), were first introduced in the 1960s as a mechanism for monitoring interim data in clinical trials in order to ensure the safety of the participating subjects. The key concept was to recruit board members who were expert in the field of interest but not otherwise intimately involved in the study (that is, not organizers, sponsors, or investigators), so that they could be objective in their assessment of issues that arose during the study. Over the past decade, the use of data and safety monitoring boards has . . . [Full Text of this Article]

The Obligation to Protect and Serve

Disclosure of Interim Data

Disclosure of General Risks as Part of Informed Consent

Publicizing the Board's Decisions and Rationale

Conclusions

Source Information

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 arthur.slutsky@utoronto.ca.

Related Letters:

Data Safety and Monitoring Boards
Wells R. J., Slutsky A. S., Lavery J. V.
Extract | Full Text | PDF  
N Engl J Med 2004; 350:2423, Jun 3, 2004. Correspondence

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