The need for more efficient trial designs

The development lifecycle of most clinical products eventually includes the requirement of clinical trials. The objective of the clinical trials usually is the demonstration of the safety and efficacy of the product. The standard methods for sample size determination of these trials have the potenti...

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Bibliographic Details
Published in:Statistics in medicine 2006-10, Vol.25 (19), p.3231-3235
Main Author: Golub, Howard L.
Format: Article
Language:English
Subjects:
Clinical medicine
Clinical trials
Clinical Trials as Topic - methods
Clinical Trials as Topic - statistics & numerical data
effect size
interim analyses
Medical statistics
Research Design
Sample Size
smallest clinically important effect (SCIE)
Treatment Outcome
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Summary:The development lifecycle of most clinical products eventually includes the requirement of clinical trials. The objective of the clinical trials usually is the demonstration of the safety and efficacy of the product. The standard methods for sample size determination of these trials have the potential to be extremely inefficient. Adaptive techniques, in certain circumstances, have the potential to result in much more efficient designs. This would then result in the reduction of unnecessary additional exposure of study subjects to experimental products, and help minimize the costs and time to arrive at a statistically appropriate answer to the primary study questions. Copyright © 2006 John Wiley & Sons, Ltd.
ISSN:0277-6715
1097-0258
DOI:10.1002/sim.2629