Adaptive sample size modification in clinical trials: start small then ask for more?
Author:
Affiliation:
1. Department of Mathematical Sciences; University of Bath; Bath U.K.
2. School of Operations Research and Information Engineering; Cornell University; Ithaca NY U.S.A.
Publisher
Wiley
Subject
Statistics and Probability,Epidemiology
Link
http://onlinelibrary.wiley.com/wol1/doi/10.1002/sim.6575/fullpdf
Reference26 articles.
1. US Food and Drug Administration Guidance for Industry: Adaptive Design Clinical Trials for Drugs and Biologics (draft) FDA: Silver Spring, MD 2010 http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM201790.pdf
2. Evaluation of experiments with adaptive interim analyses;Bauer;Biometrics,1994
3. Self-designing clinical trials;Fisher;Statistics in Medicine,1998
4. Modification of sample size in group sequential clinical trials;Cui;Biometrics,1999
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