New Adaptive Blinded Sample Size Adjustment Method for Risk Differences in Clinical Trials

Date: 05 May 2016  |  Topic: Adaptive Trial Design
Andrew Hartley, Ph.D.

Andrew Hartley, Ph.D.

Statistical Science Director

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Adaptive sample size adjustment (SSA) for clinical trials consists of examining early subsets of on-trial data to adjust sample size requirements. Blinded SSA is often preferred over unblinded SSA because it obviates many logistical complications of the latter and generally introduces less bias. On the other hand, current blinded SSA methods for binary data offer little to no new information about the treatment effect, ignore uncertainties associated with the population treatment proportions, and/or depend on enhanced randomization schemes that risk partial unblinding.

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