Recommendations for data monitoring committees from the Clinical Trials Transformation Initiative

Clinical Trials

Volumn 14, Issue 4, 2017, Pages 342-348

  Calis, Karim A ^a,b   Archdeacon, Patrick ^a   Bain, Raymond ^c   DeMets, David ^d   Donohue, Miriam ^e   Elzarrad, M Khair ^f   Forrest, Annemarie ^g   McEachern, John ^h   Pencina, Michael J ⁱ   Perlmutter, Jane ^j   Lewis, Roger J ^k  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT   (United States)

^c MERCK RESEARCH LABORATORIES   (United States)

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

^e IQVIA   (United States)

^f NATIONAL INSTITUTES OF HEALTH   (United States)

^g Clinical Trials Transformation Initiative (CTTI)   (United States)

^h PAREXEL INTERNATIONAL   (United States)

ⁱ DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^j NONE   (United States)

^k HARBOR UCLA MEDICAL CENTER   (United States)

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Author keywords

clinical trials; data and safety monitoring boards; Data monitoring committees

Indexed keywords

ADVISORY COMMITTEE; ARTICLE; CLINICAL PROTOCOL; CLINICAL TRIAL (TOPIC); CONFLICT OF INTEREST; EDUCATION PROGRAM; INTERPERSONAL COMMUNICATION; MENTORING; PATIENT SAFETY; PRIORITY JOURNAL; PROFESSIONAL STANDARD; RISK BENEFIT ANALYSIS; STATISTICAL ANALYSIS; STUDY DESIGN; CONSENSUS; HUMAN; INTERDISCIPLINARY COMMUNICATION; METHODOLOGY; ORGANIZATION AND MANAGEMENT; STANDARDS; TOTAL QUALITY MANAGEMENT;

CLINICAL TRIALS AS TOPIC; CLINICAL TRIALS DATA MONITORING COMMITTEES; CONSENSUS; DATA INTERPRETATION, STATISTICAL; HUMANS; INTERDISCIPLINARY COMMUNICATION; QUALITY IMPROVEMENT; RESEARCH DESIGN;

EID: 85026442641     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774517707743     Document Type: Article

References (8)

1. 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. Control Clin Trials 1988; 9: 137-148.
2. SCT Working Group on Data Monitoring, Dixon DO, Freedman RS, et al. Guidelines for data and safety monitoring for clinical trials not requiring traditional data monitoring committees. Clin Trials 2006; 3: 314-319.
3. Calis KA, Archdeacon P, Bain RP, et al. Understanding the functions and operations of data monitoring committees: survey and focus group findings. Clin Trials 2017; 14: 59-66.
4. Clinical Trials Transformation Initiative. CTTI data monitoring committees project expert meeting., https://www.ctti-clinicaltrials.org/briefing-room/meetings/ctti-data-monitoring-committees-project-expert-meeting (2015,. accessed 25 July 2016).
5. American Heart Association. Consensus-based decision-making processes., https://www.heart.org/idc/groups/heart-public/@wcm/@mwa/documents/downloadable/ucm-454080.pdf (. accessed 5 August 2016).
6. DeMets DL, Ellenberg SS., Data monitoring committees-expect the unexpected. New Engl J Med 2016; 375: 1365-1371.
7. Office of Inspector General. Data and safety monitoring boards in NIH clinical trials meeting guidance, but facing some issues. Washington, DC: Department of Health and Human Services, Office of Inspector General, 2013.
8. Duke Clinical Research Institute (DCRI). DCRI leadership in data monitoring committees., http://dmc.dcri.org/ (. accessed 8 September 2016).