A joint industry-sponsored data monitoring committee model for observational, retrospective drug safety studies in the real-world setting.

ABSTRACT:

Purpose

To share better practice in establishing data monitoring committees (DMCs) for observational, retrospective safety studies with joint-industry sponsorship.

Methods

A DMC model was created to monitor data from an observational, retrospective, post-authorization safety study investigating risk of medullary thyroid cancer in patients treated with long-acting glucagon-like peptide-1 receptor agonists (LA GLP-1RAs) (NCT01511393). Sponsors reviewed regulatory guidelines, best practice and sponsors' standard operation procedures on DMCs. Discussions were held within the four-member consortium, assessing applicability to observational, retrospective, real-world studies. A DMC charter was drafted based on a sponsor-proposed, adapted DMC model. Thereafter, a kick-off meeting b

SUBMITTER: Major-Pedersen A 

PROVIDER: S-EPMC8247341 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature