This is just here as a test because I lose it

Term information

alternative term

pivotal trial

creator

Asiyah Yu Lin

date

2021-06-10T16:49:17Z

definition

A clinical trial is conducted for the purpose of demonstrating the efficacy of a new drug in order to obtain its marketing approval by regulatory authorities (e.g. FDA in the United States and EMA in Europe). The pivotal clinical trial usually is a Phase III clinical trial, but exceptionally phase 2 studies could also be utilized as pivotal trials.

definition source

https://en.wikipedia.org/wiki/Pivotal_trial

https://www.sofpromed.com/pivotal-clinical-trials-frequently-asked-questions/

editor note

This is the same terms as the pre-version of this ontology: Clinical Trials Ontology - Neurodegenerative Diseases: http://www.co-ode.org/ontologies/ont.owl#Pivotal_trial

Term relations

Subclass of: