Audit of Data Sharing by Pharmaceutical Companies for Anticancer Medicines Approved by the US Food and Drug Administration
- The study examines the eligibility for individual participant data (IPD) sharing from clinical trials that supported the FDA approval of anticancer medicines over the past 10 years.
- Of the 304 trials analyzed, 136 (45%) were eligible for IPD sharing, while 168 (55%) were not.
- IPD sharing rates varied significantly among industry sponsors, with some sponsors sharing less than 10% of trial data for top-selling anticancer drugs.
- The most common reason for ineligibility was ongoing collection of long-term follow-up data (53% of ineligible trials).
- Although there has been progress in IPD transparency in the past 5 years, more than half of pivotal oncology trials remain inaccessible to qualified researchers.
- The study suggests that making all trial data available at the time of FDA registration could greatly improve data accessibility.
Decisions by regulators and clinicians on whether to approve and use new medications are typically based on findings from pivotal clinical trials. For most newer medicines, an industry sponsor drives the early generation of the evidence base supporting the medicine, but this process requires access to and facilitation by global healthcare systems. Data from early clinical trials remain the centerpiece of safety and efficacy assessments, at least until postmarketing data can reach maturity. Transparent sharing of individual participant data (IPD) from clinical trials facilitates enrichment of the postapproval evidence base through novel secondary analyses and informs the design of future studies.
In 2010, the European Medicines Agency began adopting forward-looking policies that promote clinical trial data sharing at the time of market authorization. In 2014, the pharmaceutical industry, via the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), acknowledged the importance of IPD sharing and endorsed a commitment to sharing anonymized IPD for approved medicines upon request by qualified researchers. A 2018 audit reported that data from only 15% of clinical trials were available for sharing 2 years after publication of the primary outcome, with no sharing occurring for oncology trials. Since 2018, there has been substantial development of resources and systems to facilitate research using transparently shared IPD, and progress has been made by the pharmaceutical industry to develop data sharing policies and processes. Thus, the status of IPD sharing of pivotal oncology trials warrants reevaluation.
Sharing of IPD is critical for highly used newer medicines when the evidence underpinning their use is almost exclusively derived from clinical trials supporting the medicines’ approval. Despite being one of the most active areas for drug development over the past decade, there is limited data regarding the sharing of anonymized IPD underlying pivotal oncology trials for newer anticancer medicines. This study evaluated the eligibility of independent, qualified researchers to access IPD from oncology trials that supported the US Food and Drug Administration (FDA) approval of new anticancer medicines within the past 10 years.
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