June 2022: What’s New on ClinicalTrials.gov

On June 15, 2022, the below update was posted on ClinicalTrials.gov, What’s New section

The British Medical Journal (BMJ) has published an article specifying the approaches to report master protocol study designs on ClinicalTrials.gov.

A master protocol is a unified study design and operational aspect conducted with a collection of trials or substudies in patients having same or different diseases and that employ one or multiple drugs to treat them. It helps achieve better coordination than can be achieved in single trials designed and conducted independently.

This article proposes reporting each master protocol research programs (MPRPs) substudy in a separate study record to allow for meaningful descriptions of each substudy and to better support the transparency and accountability. Other factors that require further consideration include coordinating the registration and results reporting of MPRPs, supporting the identification of MPRP related records, and harmonizing trial registries worldwide

Other Publications on ClinicalTrials.gov can be found here: Selected publications