Enhancing trial integrity by protecting the independence of data monitoring committees in clinical trials

Journal of Biopharmaceutical Statistics

Volumn 24, Issue 5, 2014, Pages 968-975

  Fleming, Thomas R ^a   Hennekens, Charles H ^b   Pfeffer, Marc A ^c   Demets, David L ^d  

^a UNIVERSITY OF WASHINGTON   (United States)

^b FLORIDA ATLANTIC UNIVERSITY   (United States)

^c BRIGHAM AND WOMEN S HOSPITAL   (United States)

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

Author keywords

Confidentiality; Conflict of interest; DMC charter; Indemnification

Indexed keywords

CLINICAL TRIAL (TOPIC); CONFERENCE PAPER; CONFIDENTIALITY; CONFLICT OF INTEREST; CONSENSUS DEVELOPMENT; CONTRACT; EMPLOYEE; EXPERIENCE; HUMAN; LEADERSHIP; PRIORITY JOURNAL; PROFESSIONAL STANDARD; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESPONSIBILITY; SAFETY; STATISTICAL ANALYSIS; TRAINING; DECISION MAKING; LEGISLATION AND JURISPRUDENCE; ORGANIZATION AND MANAGEMENT; PROFESSIONAL PRACTICE; STATISTICS AND NUMERICAL DATA;

CLINICAL TRIALS DATA MONITORING COMMITTEES; CONFIDENTIALITY; CONFLICT OF INTEREST; DATA INTERPRETATION, STATISTICAL; DECISION MAKING; PROFESSIONAL AUTONOMY; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84905986814     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543406.2014.925719     Document Type: Conference Paper

References (8)

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4. Hennekens, C. H., DeMets, D. (2009). The need for large scale randomized evidence without undue emphasis on small trials, meta-analyses or subgroup analyses. Journal of the American Medical Assocation 302:2361-2362.
5. Hennekens, C. H., DeMets, D. (2011). Data and safety monitoring boards of randomized trials: Emerging principles and practical suggestions. Clinical Investigation 1:1-5.
6. Shalala, D. (2000). Protecting research subjects-What must be done. New England Journal of Medicine 343:808-810.
7. Tereskerz, P. (2010). Data safety monitoring boards. Accountability in Research 17:30-50.
8. U.S. Food and Drug Administration. (2005). Guidance for clinical trial sponsors: Establishment and operation of clinical trial data monitoring committees. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ UCM127073.pdf