Coordinating data monitoring committees and adaptive clinical trial designs

Drug Information Journal

Volumn 42, Issue 4, 2008, Pages 297-301

  Herson, Jay ^a  

^a JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH   (United States)

Author keywords

Adaptive design; Data analysis center; Data monitoring committee; Internal safety review committee

Indexed keywords

ARTICLE; CLINICAL DECISION MAKING; CLINICAL RESEARCH; DRUG EFFICACY; DRUG MONITORING; DRUG SAFETY; INFORMATION DISSEMINATION; METHODOLOGY; PRIORITY JOURNAL; PROFESSIONAL STANDARD;

EID: 51049098442     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286150804200401     Document Type: Article

References (7)

1. US Food and Drug Administration. Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees. Rockville, MD: Food and Drug Administration; 2006.
2. Sydes MR, Spiegelhalter DJ, Altman DG, Babiker AB, Parmar MKB, and the DAMOCLES Group. Systematic qualitative review of the literature on data monitoring committees for randomized controlled trials. Clin Trials. 2004;1:60-79.
3. Ellenberg SS, Fleming TR, DeMets DL. Data Monitoring Committees in Clinical Trials: A Practical Perspective. New York: John Wiley & Sons; 2002.
4. Gallo P, Krams M. PhRMA working group on adaptive designs: introduction to the full white paper. Drug Inf J. 2006;40:421-423.
5. Dragalin V. Adaptive designs: terminology and classification. Drug Inf J. 2006;40:425-435.
6. D'Agostino RB, Massaro JM, Sullivan LM. Non-inferiority trials: design concepts and issues - the encounters of academic consultants in statistics. Stat Med. 2003;22(2):169-186.
7. Chuang-Stein C, Anderson K, Gallo P, Collins S. Sample size re-estimation: a review and recommendations. Drug Inf J. 2006;40:475-484.