Understanding the functions and operations of data monitoring committees: Survey and focus group findings

Clinical Trials

Volumn 14, Issue 1, 2017, Pages 59-66

  Calis, Karim A ^a,b   Archdeacon, Patrick ^a   Bain, Raymond P ^c   Forrest, Annemarie ^d   Perlmutter, Jane ^e   DeMets, David L ^f  

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

^e Gemini Group   (United States)

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

Author keywords

benefit; clinical trial; Data monitoring committee; futility; interim analysis; safety; statistical data interpretation

Indexed keywords

ACCESS TO INFORMATION; ARTICLE; EARLY TERMINATION OF CLINICAL TRIAL; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; HEALTH CARE ORGANIZATION; HEALTH CARE PERSONNEL; HEALTH CARE SURVEY; HUMAN; INTERPERSONAL COMMUNICATION; MEDICAL ETHICS; MEDICAL EXPERT; NON PROFIT ORGANIZATION; PROFESSIONAL STANDARD; RANDOMIZED CONTROLLED TRIAL (TOPIC); REMUNERATION; RISK BENEFIT ANALYSIS; TELECONFERENCE; UNITED STATES; CLINICAL TRIAL (TOPIC); INFORMATION PROCESSING; PATIENT SAFETY; QUESTIONNAIRE; STATISTICAL ANALYSIS; TREATMENT OUTCOME;

CLINICAL TRIALS AS TOPIC; CLINICAL TRIALS DATA MONITORING COMMITTEES; DATA INTERPRETATION, STATISTICAL; ETHICS COMMITTEES, RESEARCH; FOCUS GROUPS; HUMANS; MEDICAL FUTILITY; PATIENT SAFETY; PROFESSIONAL ROLE; SURVEYS AND QUESTIONNAIRES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 85012067091     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774516679665     Document Type: Article

References (14)

1. Ellenberg SS., Protecting clinical trial participants and protecting data integrity: are we meeting the challenges? PLoS Med 2012; 9: e1001234
2. Ellenberg SS, Fleming TR, DeMets DL., Data monitoring committees in clinical trials: a practical perspective. Chichester: John Wiley & Sons, 2002
3. 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
4. Califf RM, Zarin DA, Kramer JM, et al. Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010. JAMA 2012; 307: 1838-1847
5. Seltzer J., An estimate of the benefit-cost impact of the FDA guidance on data monitoring committees. Ther Innov Regul Sci 2015; 49: 698-705
6. Hess CN, Roe MT, Gibson CM, et al. Independent data monitoring committees: preparing a path for the future. Am Heart J 2014; 168: 135-141
7. Armstrong PW, Califf RM., Data and safety monitoring boards: academic credit where credit is due? JAMA 2013; 310: 1563-1564
8. Clinical Trials Transformation Initiative. Data Monitoring Committees: project summary., http://www.ctti-clinicaltrials.org/what-we-do/ctti-projects/dmcs (. accessed 23 February 2016)
9. Clinical Trials Transformation Initiative. CTTI recommendations: data monitoring committees., http://www.ctti-clinicaltrials.org/what-we-do/projects/dmcs/products (. accessed 8 July 2016)
10. Clinical Trials Transformation Initiative. Data Monitoring Committees: methods., http://www.ctti-clinicaltrials.org/what-we-do/ctti-projects/dmcs/methods (. accessed 23 February 2016)
11. Centers for Medicare & Medicaid Services. Medicare, Medicaid, Children's Health Insurance Programs; transparency reports and reporting of physician ownership or investment interests. Fed Regist 2013; 78: 9457-9528
12. DeMets DL, Furberg CD, Friedman LM, (eds). Data monitoring in clinical trials: a case studies approach. New York: Springer, 2006
13. National Institute of Allergy and Infectious Diseases. Data Safety Monitoring Board (DSMB) training., https://dsmblearningcenter.niaid.nih.gov/Pages/default.aspx (. accessed 23 February 2016)
14. UW Institute for Clinical and Translational Research. Online video for training DMC members., https://ictr.wisc.edu/DMCvideotrg (. accessed 23 February 2016)