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2. Outline. Two Presentations in oneMultiple Endpoint Issues (MB)DescriptionEndpointsMeasuring DiseaseComposite Endpoint as a solution (MB)Statistical Methodology (RM)IUTLRTSize, power, bias, sample size. 3. Multiple Endpoints. There is concern about an increasing trend towards requiring that confirmatory clinical trials achieve statistical significance on all of p primary endpoints, where p>1.Obviously, as p increases, it becomes more difficult to achieve success in any given disease1142

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Multiple Primary Endpoints in Clinical Trials

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