Document Detail

Ethics and practice: alternative designs for phase III randomized clinical trials.
MedLine Citation:
PMID:  10227416     Owner:  NLM     Status:  MEDLINE    
For decades, biostatisticians have developed and refined the methodology for clinical trials with the intent of giving trial participants a better representation than traditional, equal-allocation, fixed sample-size designs. Despite these methodologic advances and ethical advantages, alternative or data-dependent designs for phase III clinical trials, including sequential designs, Bayesian methods, and adaptive designs, have not been widely adopted in practice. We attempt to characterize situations under which these designs are feasible and desirable from ethical and logistical standpoints. In particular, we describe the role of individual and collective ethics in designing clinical trials and argue that greater attention should be paid to the former. We give examples of those alternative designs that have been used in practice, including discussion of their strengths and shortcomings. We conclude that alternative designs are applicable in limited classes of trials and that investigators should consider them more often when planning clinical trials.
C R Palmer; W F Rosenberger
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Publication Detail:
Type:  Journal Article; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  Controlled clinical trials     Volume:  20     ISSN:  0197-2456     ISO Abbreviation:  Control Clin Trials     Publication Date:  1999 Apr 
Date Detail:
Created Date:  1999-06-17     Completed Date:  1999-06-17     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  8006242     Medline TA:  Control Clin Trials     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  172-86     Citation Subset:  E; IM    
Centre for Applied Medical Statistics, Department of Community Medicine, Institute of Public Health, University of Cambridge, UK.
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MeSH Terms
Bayes Theorem
Clinical Trials, Phase III as Topic / classification,  methods*
Cross-Over Studies
Ethics, Medical*
Feasibility Studies
Linear Models
Medical Informatics
Practice Guidelines as Topic
Random Allocation
Randomized Controlled Trials as Topic / classification,  methods*
Research Design*
Sample Size
Selection Bias
Grant Support

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