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What is a pivotal study

A pivotal trial is a clinical trial or study intended to provide evidence for a drug marketing approval, e.g. by the United States Food and Drug Administration. Exploratory (non-pivotal) study that has clinical efficacy,. Pharmacodynamics or biological activity as primary endpoint, conducted in patients or healthy. In clinical studies, bias is controlled by blinding and randomization. .. A pivotal study will generally be well-controlled, randomized, of adequate size, and.

Define Pivotal Clinical Trial. means a randomized, controlled clinical trial of a Product designed to demonstrate statistically significant clinical efficacy and safety. Official Title: Positive Impact of Endovascular Options for Treating Aneurysms Early (PIVOTAL). Study Start Date: March Actual Primary Completion Date . Sometimes referred to as pivotal trials. Phase IIIa: Trials Phase IV: Studies or trials conducted after a medicine is marketed to provide additional details about.

Although numerous study designs can address these goals, clinical trials (and . as a “therapeutic confirmatory,” “comparative efficacy,” or “pivotal trial”) may be. Pivotal clinical trial costs increased if more patients were needed to document treatment benefit, if active drug comparators were used, or to. What is a pivotal study? More importantly, what is so "pivotal" about it? Does " pivot" refer to importance or to a statistical (mathematical) turning. Pivotal Clinical Trial: A clinical trial or study intended to provide evidence for a new treatment approval by the United States Food & Drug.

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