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A joint industry‐sponsored data monitoring committee model for observational, retrospective drug safety studies in the real‐world setting
Author(s) -
MajorPedersen Atheline,
McCullen Mary Kate,
Sabol Mary Elizabeth,
Adetunji Omolara,
Massaro Joseph,
Neugut Alfred I.,
Sosa Julie Ann,
Hollenberg Anthony N.
Publication year - 2021
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/pds.5172
Subject(s) - observational study , medicine , retrospective cohort study , patient safety , blinding , pharmacoepidemiology , law , clinical trial , pharmacology , surgery , political science , health care , medical prescription
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.