24 Jul 2016
A pivotal trial can refer to a clinical trial or study intended to provide evidence for a drug marketing approval, e.g. by the US FDA. Phase III trials are assumed to be pivotal so the phrase is often used for the rare pivotal phase II trials.
A drug pivotal study is a definitive study in which evidence is gathered to support the safety and effectiveness evaluation of thedrug for its intended use. Evidence from one or more pivotal clinical studies generally serves as the primary basis for the determination of reasonable assurance of safety and effectiveness of the drug.