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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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Key Points Question What proportion of clinical trials that underpin registration of contemporary anticancer medicines are eligible for individual participant data (IPD) sharing with qualified researchers? Findings In this quality… Click to show full abstract

Key Points Question What proportion of clinical trials that underpin registration of contemporary anticancer medicines are eligible for individual participant data (IPD) sharing with qualified researchers? Findings In this quality improvement study of the 304 trials that underpinned the US Food and Drug Administration (FDA) registration of 115 anticancer medicines over the past 10 years, 136 (45%) were eligible for IPD sharing. Meaning Although inroads have been made toward improving IPD transparency over the past 5 years, these findings suggest that a substantial portion of pivotal oncology trials that support the FDA registration of modern anticancer medicines remain unavailable to qualified researchers.

Keywords: food drug; anticancer medicines; oncology; drug administration

Journal Title: JAMA Oncology
Year Published: 2022

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