Monitoring committees: Why and how

Data Monitoring in Clinical Trials: A Case Studies Approach

Volumn , Issue , 2006, Pages 3-13

  Demets, David L ^a   Furberg, Curt D ^b   Friedman, Lawrence M ^c  

^a UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH   (United States)

^b WAKE FOREST SCHOOL OF MEDICINE   (United States)

^c NONE

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84889784733     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1007/0-387-30107-0_1     Document Type: Chapter

References (15)

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3. Canner PL. 1983. Monitoring of the data for evidence of adverse or beneficial effects. In, (Canner PL, ed.): The Coronary Drug Project. Methods and Lessons of a Multicenter Clinical Trial. Control Clin Trials 4:467-483.
4. FDA Draft Guidance on Data Monitoring Committees: http://www.fda.gov/ OHRMS/DOCKETS/98fr/010489gd.pdf
5. NIH Policy for Data and Safety Monitoring: http://grants.nih.gov/grants/ guide/noticefiles/not98-084.html
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11. Freedman B. 1987. Equipoise and the ethics of clinical research. N Engl J Med 317:141-145.
12. The World Medical Association. World Medical Association Declaration of Helsinki: Ethical principals for medical research involving human subjects. October 2000 amended version, with 2002 clarification. http://www.wma.net/e/ policy/b3.htm.
13. Canner PL. Monitoring clinical trial data for evidence of adverse or beneficial treatment effects. 1979. In Boissel JP, Klimt CR (eds.): Multicenter Controlled Trials: Principles and Problems. INSERM, Paris.
14. Rose EA, Moskowitz AJ, Packer M, Sollano JA, Williams DL, Tierney AR, Heitjan DF, Meier P, Ascheim DD, Levitan RG, Weinberg AD, Stevenson LW, Shapiro PA, Lazar RM, Watson JT, Goldstein DJ, Gelijns AC, for the REMATCH Investigators. 1999. The REMATCH trial: rationale, design, and end points. Ann Thorac Surg 67:723-730.
15. NIH Guidance on Reporting Adverse Events to Institutional Review Boards: http://grants.nih.gov/grants/guide/notice-files/not99-107.html