Individual participant data (IPD) sharing enriches the post-approval evidence-base, informs future study designs, and facilitates novel secondary analyses. Since 2014, the pharmaceutical industry has acknowledged the importance of IPD sharing via endorsing their commitments to transparent IPD sharing with qualified researchers (i.e., >95% of big-pharma companies have an IPD sharing policy). This study examined whether the IPD for key oncology trials supporting the registration of anticancer medicines approved within the past decade were eligible for sharing.
Pivotal trial results supporting FDA-approved anti-cancer medicines within the past decade were identified from product labels. The main outcome was frequency of IPD sharing eligibility. IPD sharing eligibility was confirmed by identification of a public listing of the trial as eligible for sharing or a positive response to a standardised enquiry to the sponsor.
From 2011 to 2021, 115 industry-sponsored anticancer medicines were approved by the FDA, based on the evidence of 304 industry-sponsored trials. Of the 304 trials, 136 (45%) were eligible for IPD sharing. Data sharing rates differed substantially between industry sponsors. The most common reason (89 of 168 trials) a trial would not be shared was that the collection of long-term follow-up data was continuing. Of the top 10 anticancer medicines by global sales, nivolumab, pembrolizumab, and pomalidomide had the lowest eligibility rates for data sharing (< 10% of trials).
There has been a significant increase in IPD sharing for industry-sponsored oncology trials over the past 5 years. However, it was found that >50% of queried trials for FDA-approved anticancer medicines were ineligible for IPD sharing. Data accessibility would be substantially improved if, upon registration of a medicine, all data supporting the registration was made available.