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The state of individual participant data sharing for the highest-revenue medicines

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dc.contributor.authorModi, N.D.
dc.contributor.authorLi, L.X.
dc.contributor.authorLogan, J.M.
dc.contributor.authorWiese, M.D.
dc.contributor.authorAbuhelwa, A.Y.
dc.contributor.authorMcKinnon, R.A.
dc.contributor.authorRowland, A.
dc.contributor.authorSorich, M.J.
dc.contributor.authorHopkins, A.M.
dc.date.issued2025
dc.descriptionData source: supplementary material, https://doi.org/10.1177/17407745241286147
dc.description.abstractBackgroundAmid growing emphasis from pharmaceutical companies, advocacy groups, and regulatory bodies for sharing of individual participant data, recent audits reveal limited sharing, particularly for high-revenue medicines. Therefore, this study aimed to assess the individual participant data-sharing eligibility of clinical trials supporting the Food and Drug Administration approval of the top 30 highest-revenue medicines for 2021.MethodsA cross-sectional analysis was conducted on 316 clinical trials supporting approval of the top 30 revenue-generating medicines of 2021. The study assessed whether these trials were eligible for individual participant data sharing, defined as being publicly listed on a data-sharing platform or confirmed by the trial sponsors as in scope for independent researcher individual participant data investigations. Information was gathered from various sources including ClinicalTrials.gov, the European Union Clinical Trials Register, and PubMed. Key factors such as the trial phase, completion dates, and the nature of the data-sharing process were also examined.ResultsOf the 316 trials, 201 (64%) were confirmed eligible for sharing, meaning they were either publicly listed on a data-sharing platform or confirmed by the trial sponsors as in scope for independent researcher individual participant data investigations. A total of 102 (32%) were confirmed ineligible, and for 13 (4%), the sponsor indicated that a full research proposal would be required to determine eligibility. The analysis also revealed a higher rate of individual participant data sharing among companies that utilized independent platforms, such as Vivli, for managing their individual participant data-sharing process. Trials not marked as completed had significantly lower eligibility for individual participant data sharing.ConclusionThis study highlights that a substantial portion of trials for top revenue-generating medicines are eligible for individual participant data sharing. However, challenges persist, particularly for trials that are marked as ongoing and for trials where the sharing processes are managed internally by pharmaceutical companies. Data-sharing rates could be improved by adopting open-access individual participant data-sharing models or using independent platforms. Standardizing policies to facilitate immediate individual participant data availability for approved medicines is necessary.
dc.identifier.citationClinical Trials, 2025; 22(2):170-177
dc.identifier.doi10.1177/17407745241286147
dc.identifier.issn1740-7745
dc.identifier.issn1740-7753
dc.identifier.orcidModi, N.D. [0000-0003-3262-5374]
dc.identifier.urihttps://hdl.handle.net/11541.2/40541
dc.language.isoen
dc.publisherSAGE Publications
dc.relation.fundingNHMR 2005294
dc.relation.fundingNHMR 2008119
dc.relation.fundingCancer Council South Australia
dc.rightsCopyright 2024 The Authors (https://creativecommons.org/licenses/by-nc/4.0/) Access Condition Notes: For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.
dc.source.urihttps://doi.org/10.1177/17407745241286147
dc.subjectHumans
dc.subjectCross-Sectional Studies
dc.subjectDrug Approval
dc.subjectInformation Dissemination
dc.subjectUnited States Food and Drug Administration
dc.subjectDrug Industry
dc.subjectUnited States
dc.subjectClinical Trials as Topic
dc.titleThe state of individual participant data sharing for the highest-revenue medicines
dc.typeJournal article
pubs.publication-statusPublished
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ror.mmsid9916906912101831

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