Responsibilities of Data Monitoring Committees: Consensus Recommendations

Therapeutic Innovation and Regulatory Science

Volumn 50, Issue 5, 2016, Pages 648-659

  Bierer, Barbara E ^a   Li, Rebecca ^a   Seltzer, Jonathan ^b   Sleeper, Lynn A ^c   Frank, Elizabeth ^d   Knirsch, Charles ^e   Aldinger, Carmen E ^a   Levine, Robert J ^f   Massaro, Joe ^g   Shah, Amish ^h   Barnes, Mark ^a,h   Snapinn, Steven ⁱ   Wittes, Janet ^j  

^a BRIGHAM AND WOMEN S HOSPITAL   (United States)

^b ACI Clinical   (United States)

^c BOSTON CHILDREN S HOSPITAL   (United States)

^d DANA FARBER CANCER INSTITUTE   (United States)

^e PFIZER INC   (United States)

^f YALE UNIVERSITY   (United States)

^g BOSTON UNIVERSITY   (United States)

^h Ropes and Gray   (United States)

ⁱ AMGEN INC   (United States)

^j University of Iowa   (United States)

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Author keywords

clinical trials; Data Monitoring Committees; human subject safety; multi site clinical trials; oversight of clinical trials; safety data

Indexed keywords

ARTICLE; CLINICAL TRIAL (TOPIC); DOCUMENTATION; HUMAN; INTERPERSONAL COMMUNICATION; MEDICAL LIABILITY; PATIENT SAFETY; PRIORITY JOURNAL; PROFESSIONAL STANDARD; RESEARCH ETHICS; RESEARCH SUBJECT;

EID: 84983802145     PISSN: 21684790     EISSN: 21684804     Source Type: Journal    
DOI: 10.1177/2168479016646812     Document Type: Article

References (8)

1. D.DeMetsC.FurbergL.Friedman. Data Monitoring in Clinical Trials. New York: Springer Verlag; 2006.
2. S.EllenbergT.FlemingD.DeMets. Data Monitoring Committees in Clinical Trials: A Practical Perspective. Chichester, England: J. Wiley & Sons; 2002.
3. US Food and Drug Administration. Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees. Silver Spring, MD: US FDA; 2006.
4. J.WittesBehind closed doors: The data monitoring board in randomized clinical trials. Statist Med. 1993;12(5-6):419–424.
5. D.DeMetsT.FlemingF.Rockhold. Liability issues for data monitoring committee members. Clin Trials. 2004;1(6):525–531.
6. J.WittesM.Schactman. On independent data monitoring committees in oncology clinical trials. Chin Clin Oncol. 2014;3(3).
7. US Food and Drug Administration. Safety assessment for investigational new drug application safety reporting; draft guidance for industry; availability. Vol FDA-2015-D-4562-00012015.
8. S.GlickmanJ.McHutchisonE.Peterson. Ethical and scientific implications of the globalization of clinical research. N Engl J Med. 2009;360(8):816–823.