2018
DOI: 10.1002/jcph.1074
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Is It Time for Going Beyond the P‐Value Paradigm With the Estimation of the Probability of Clinical Benefit as a Criterion for Assessing the Outcomes of a Clinical Trial? A Case Study in Patients With Major Depressive Disorder

Abstract: The conventional statistical methodologies for evaluating treatment effect are based on hypothesis testing (P-value). Alternative measurements of treatment effect have been proposed for anti-infective treatments using the probability of target attainment. A general framework is proposed to extend this methodology to other therapeutic areas. A disease trial model is used for estimating the probability of reaching a treatment effect associated with relevant clinical benefits, in complement to the evaluation of t… Show more

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References 32 publications
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