On the Lower Predictive Bound Approach for Non-Inferiority Clinical Trials with Binary Data
View Presentation Yulan Li, Novartis Pharmaceutical Corporation *Qing Liu, Janssen Research & Development Keywords: Conditional type 1 error rate, Lower confidence bound approach, Predictive confidence level, Retention of effect, Synthesis approach. We propose a predictive bound approach to determine the non-inferiority margin. This allows indirect statistical inference (i.e., p-values, confidence intervals and point estimates) on the effect of a new test drug against a putative placebo upon completion of the non-inferiority trial. We also develop a framework to evaluate the robustness of any non-inferiority margin approach against the constancy assumption, selection bias and variability of the historical data. With a proper choice of the predictive confidence level, the predictive bound approach ensures that the non-inferiority test remains interpretable even though the constancy assumption does not hold.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
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August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
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August 26, 2013
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September 9, 2013
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September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC