Pivotal trial

As a key study (in English pivotal study = central / pivotal trial, therefore dt often referred to as pivotal study ) is in medical research refers to a clinical trial, which aims to the significant efficacy of a therapeutic procedure ( for example, a drug ) to provide. Usually it involves a clinical phase II study, often referred to as a Phase IIb study in which the efficacy of a drug against placebo is checked. The data obtained from the key study form in addition to the Phase I studies ( tolerability in healthy volunteers ), the phase IIa studies (dose -response relationship ) and the phase III trials, in which an active agent with an established reference product is compared, the basis for the filings with the appropriate regulatory authorities drug Application. After granted marketing approval an ongoing phase III trial is then expressed as a phase IIIb study. Studies that are conducted after the launch, are referred to as Phase IV studies.

• Survey method ( Clinical Research)