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Audit of Data Sharing by Pharmaceutical Companies for Anticancer Medicines Approved by the US Food and Drug Administration

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dc.contributor.authorModi, N.D.
dc.contributor.authorAbuhelwa, A.Y.
dc.contributor.authorMckinnon, R.A.
dc.contributor.authorBoddy, A.V.
dc.contributor.authorHaseloff, M.
dc.contributor.authorWiese, M.D.
dc.contributor.authorHoffmann, T.C.
dc.contributor.authorPerakslis, E.D.
dc.contributor.authorRowland, A.
dc.contributor.authorSorich, M.J.
dc.contributor.authorHopkins, A.M.
dc.date.issued2022
dc.descriptionData source: Supplemental content, https://jamanetwork.com/journals/jamaoncology/fullarticle/2794806#supplemental-tab
dc.description.abstract<h4>Importance</h4>Emerging policies drafted by the pharmaceutical industry indicate that they will transparently share clinical trial data. These data offer an unparalleled opportunity to advance evidence-based medicine and support decision-making.<h4>Objective</h4>To evaluate the eligibility of independent, qualified researchers to access individual participant data (IPD) from oncology trials that supported US Food and Drug Administration (FDA) approval of new anticancer medicines within the past 10 years.<h4>Design, setting, and participants</h4>In this quality improvement study, a cross-sectional analysis was performed of pivotal clinical trials whose results supported FDA-approved anticancer medicines between January 1, 2011, and June 30, 2021. These trials' results were identified from product labels.<h4>Exposures</h4>Eligibility for IPD sharing was confirmed by identification of a public listing of the trial as eligible for sharing or by receipt of a positive response from the sponsor to a standardized inquiry.<h4>Main outcomes and measures</h4>The main outcome was frequency of IPD sharing eligibility. Reasons for data sharing ineligibility were requested and collated, and company-, drug-, and trial-level subgroups were evaluated and presented using χ2 tests and forest plots.<h4>Results</h4>During the 10-year period examined, 115 anticancer medicines were approved by the FDA on the basis of evidence from 304 pharmaceutical industry-sponsored trials. Of these trials, 136 (45%) were eligible for IPD sharing and 168 (55%) were not. Data sharing rates differed substantially among industry sponsors, with the most common reason for not sharing trial IPD being that the collection of long-term follow-up data was still ongoing (89 of 168 trials [53%]). Of the top 10 anticancer medicines by global sales, nivolumab, pembrolizumab, and pomalidomide had the lowest eligibility rates for data sharing (<10% of trials).<h4>Conclusions and relevance</h4>There has been a substantial increase in IPD sharing for industry-sponsored oncology trials over the past 5 years. However, this quality improvement study found that more than 50% of queried trials for FDA-approved anticancer medicines were ineligible for IPD sharing. Data accessibility would be substantially improved if, at the time of FDA registration of a medicine, all data that support the registration were made available.
dc.identifier.citationJAMA Oncology, 2022; 8(9):1310-1316
dc.identifier.doi10.1001/jamaoncol.2022.2867
dc.identifier.issn2374-2437
dc.identifier.issn2374-2445
dc.identifier.orcidModi, N.D. [0000-0003-3262-5374]
dc.identifier.urihttps://hdl.handle.net/11541.2/31012
dc.language.isoen
dc.publisherAmerican Medical Association (AMA)
dc.relation.fundingCancer Council South Australia Beat Cancer research fellowship
dc.relation.fundingNHMRC 2008119
dc.relation.fundingNHMRC 2005294
dc.rightsCopyright 2022 Modi ND et al. JAMA Oncology. This is an open access article distributed under the terms of the CC-BY License (https://jamanetwork.com/pages/cc-by-license-permissions)
dc.source.urihttps://doi.org/10.1001/jamaoncol.2022.2867
dc.subjectHumans
dc.subjectNeoplasms
dc.subjectAntineoplastic Agents
dc.subjectPharmaceutical Preparations
dc.subjectCross-Sectional Studies
dc.subjectDrug Approval
dc.subjectInformation Dissemination
dc.subjectUnited States Food and Drug Administration
dc.subjectUnited States
dc.subjectNivolumab
dc.titleAudit of Data Sharing by Pharmaceutical Companies for Anticancer Medicines Approved by the US Food and Drug Administration
dc.typeJournal article
pubs.publication-statusPublished
ror.fileinfo12252249710001831 13252259480001831 Open Access Published Version
ror.mmsid9916672830501831

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