A Joint Industry-sponsored Data Monitoring Committee Model for Observational, Retrospective Drug Safety Studies in the Real-world Setting

Overview

Journal Pharmacoepidemiol Drug Saf

Publisher Wiley

Specialties Pharmacology
Public Health

Date 2020 Nov 12

PMID 33179845

Citations 1

Authors

Atheline Major-Pedersen

Mary Kate McCullen

Mary Elizabeth Sabol

Omolara Adetunji

Joseph Massaro

Alfred I Neugut

Julie Ann Sosa

Anthony N Hollenberg

Affiliations

Soon will be listed here.

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 between sponsors and DMC members was held to receive DMC input and finalize the charter.

Results: Due to this study's observational, retrospective nature, assuring participant safety - central for traditional explanatory clinical trial models - was not applicable to our DMC model. The overall strategy and key indication for our real-world model included preserving study integrity and credibility. Therefore, DMC member independence and their contribution of expert knowledge were essential. To ensure between-sponsor data confidentiality, all study committees/corporations and sponsors, besides the DMC, received blinded data only (adapted to refer to data blinding that revealed the specific marketed LA GLP-1RA/sponsor). Communication and blinding/unblinding of these data were facilitated by the contract research organization, which also provided crucial operational oversight.

Conclusions: To our knowledge, we have established the first DMC model for joint industry-sponsored, observational, retrospective safety studies. This model could serve as a precedent for others performing similar post-marketing, joint industry-sponsored pharmacovigilance activities.

Citing Articles

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

Major-Pedersen A, McCullen M, Sabol M, Adetunji O, Massaro J, Neugut A Pharmacoepidemiol Drug Saf. 2020; 30(1):9-16.

PMID: 33179845 PMC: 8247341. DOI: 10.1002/pds.5172.

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