Should all trials have a Data Safety and Monitoring Committee?

References 

1. Califf RM, McNulty SE, Adams KF, et al.  A randomized controlled trial of epoprostenol therapy for heart failure: the Flolan International Randomized Survival Trial (FIRST). Am Heart J. 1997;134:44–55
   • Abstract
   • Full Text
   • Full-Text PDF (1144 KB)
   • CrossRef
2. Nelson D, Weiss R. FDA stops researcher’s human gene therapy experiments. Washington Post. 2000 March 2;A08
3. Hilts PJ. FDA says researchers failed to report a second death linked to gene therapy. New York Times. 2000 May 4;A-20
4. Permissible medical experiments . In: trials of war criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Nuremberg,. Volume 2:Washington (DC): US Government Printing Office; October 1946–April 1949;p. 181–182
5. Adopted by the 18th World Medical Assembly, Helsinki, Finland, 1964, and amended in Tokyo in 1975, in Venice in 1983, in Hong Kong in 1989, and in South Africa in Declaration of Helsinki. 1996;
6. US Code of Federal Regulations. Department of Health and Human Services; National Institutes of Health, Office for Protection from Research Risks; 19 August 1991; Title 45, Public Welfare Section 46: Protection of human subjects. Revised 18 June 1991; effective
7. Green SJ, Fleming TR, O’Fallon JR. Policies for study monitoring and interim reporting of results. J Clin Oncol. 1987;5:1477–1484
   • MEDLINE
8. Frasure-Smith N, Lesperance F, Talajic M. Depression following myocardial infarction: impact on 6-month survival. JAMA. 1993;270:1819–1825
   • MEDLINE
9. Frasure-Smith N, Lesperance F, Talajic M. Depression and survival following myocardial infarction. JAMA. 1994;271:1080–1082
   • MEDLINE
10. Office of Inspector General . Institutional Review Boards: a time for reform. The Office;. Publication No.: OEI-01-97-00193 1998;
11. Meinert CL, Knatterud GL, Prout TE, et al.  University Group Diabetes Program: a study of the effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes. Diabetes. 1970;19:789–830
12. Anonymous . Organization, review, and administration of cooperative studies (Greenberg Report): a report from the Heart Special Project Committee to the National Advisory Heart Council, May 1967. Controlled Clin Trials. 1988;9:137–148
    • MEDLINE
    • CrossRef
13. Halperin M, DeMets DL, Ware JH. Early methodological developments for clinical trials at the National Heart, Lung and Blood Institute. Stat Med. 1990;9:881–892 903–6
    • MEDLINE
    • CrossRef
14. National Institutes of Health . NIH policy for data and safety monitoring. Release date Available at http://www.//grants.nih.gov/grants/guide/notice-files/not98-084.htmlJune 10, 1998;
15. US Food and Drug Administration , Department of Health , Human Services: Office of Regulatory Affairs . Guidance for Institutional Review Boards, clinical investigators, and sponsors: exception from informed consent requirements for emergency research. Draft guidance. Available at http://www.fda.gov/ora/compliance_ref/bimo/err_guide.htm (released for comment on 3-30-2000). Section VII: Data monitoring.
16. National Institutes of Health . Further guidance on data and safety monitoring for phase I and phase II trials. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.htmlJune 5, 2000.; Available at