Key study

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As a key study ( engl . Pivotal study = central / pivotal trial, therefore dt. Often called pivotal study referred to) is a medical research clinical study referred to, which has the purpose, the significant efficacy of a therapeutic procedure (e.g., a medicament ) to provide. As a rule, this is a phase III clinical study in which the proof of effectiveness of an active ingredient is tested against placebo or the standard of therapy. In addition to the phase I studies (tolerance in healthy volunteers) and the phase II studies (proof of concept, dose-response relationship), the data obtained from the key study form the basis for the application for drug approval to be submitted to the relevant drug authorities . Once marketing authorization has been granted, an ongoing phase III study is then designated as a phase IIIb study. Post-marketing studies are known as phase IV studies.