You may have worked on more adaptive designs than you think

Stroke

Volumn 46, Issue 2, 2015, Pages e26-e28

  Coffey, Christopher S ^a  

^a UNIVERSITY OF IOWA   (United States)

Author keywords

adaptive designs; clinical trials; clinical trials data monitoring committee; early termination of clinical trials; group sequential designs

Indexed keywords

ARTICLE; CEREBROVASCULAR ACCIDENT; DOSE RESPONSE; HUMAN; NULL HYPOTHESIS; PRIORITY JOURNAL; SEQUENTIAL ANALYSIS; STATISTICAL ANALYSIS; STUDY DESIGN; CLINICAL TRIAL (TOPIC); METHODOLOGY; STANDARDS; STROKE; TRENDS;

CLINICAL TRIALS AS TOPIC; HUMANS; RESEARCH DESIGN; STROKE;

EID: 84942893365     PISSN: 00392499     EISSN: 15244628     Source Type: Journal    
DOI: 10.1161/STROKEAHA.114.004288     Document Type: Article

References (5)

1. Coffey CS, Levin B, Clark C, Timmerman C, Wittes J, Gilbert P, et al. Overview, hurdles, and future work in adaptive designs: perspectives from a National Institutes of Health-funded workshop. Clin Trials. 2012;9:671-680. doi: 10.1177/1740774512461859.
2. Gaydos B, Anderson KB, Berry D, Burnham N, Chuang-Stein C, Dudinak J, et al. Good practices for adaptive clinical trials in pharmaceutical product development. Drug Inf J. 2009;43:539-556.
3. Proschan MA, Lan KKG, Wittes JT. Statistical Monitoring of Clinical Trials: A Unified Approach. New York: Springer; 2006.
4. Gallo P, Chuang-Stein C, Dragalin V, Gaydos B, Krams M, Pinheiro J; for the PhRMA Working Group. Adaptive designs in clinical drug development-an executive summary of the PhRMA Working Group. J Biopharm Stat. 2006;16:275-283.
5. Food and Drug Administration. Guidance for industry: Adaptive Design Clinical Trials for drugs and biologics. 2010. http://www.fda. gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM201790.pdf. Accessed April 3, 2014.