JAMA study finds cancer drug data is still largely unavailable to qualified researchers
As data sharing has become more helpful and relevant to researchers in the past few years, a new report in JAMA Oncology shows that the availability of cancer drugs’ clinical trial data is still lagging for researchers.
An audit from Australian researchers found that less than half of individual participants’ data from trials is shared with researchers.
The report, which was published on Thursday, noted that decisions by regulators and clinicians on whether to approve and use new medications are typically based on findings from pivotal clinical trials.
While efforts to increase sharing have been spurred by the EMA and PhRMA, as well as acknowledging the importance of individual participant data (IPD) sharing, the study shows that data from only 15% of clinical trials were available for sharing two years after publication, with no info trading hands for oncology trials.
The current JAMA report recognized that since 2018, there has been substantial development of resources and systems to facilitate research using transparently shared IPD as well as progress from the pharma industry to develop more data sharing policies.
For the report, the researchers looked at all the cancer medicines approved by the FDA between January 2011 and June 2021 and revealed that of the 304 trials done during the window, only 45% were eligible for IPD sharing with independent researchers.
The study also found that companies such as AbbVie, Bayer, Gilead and Takeda had less than 50% of their oncology trials available for IPD sharing. But others like Astellas, Bristol Myers Squibb, GSK, Merck and Teva had less than 10% available for sharing. Drugs such as nivolumab, pembrolizumab, and pomalidomide also have less than 10% of data available for researchers.
“Because these trials form the basis of safety and efficacy claims for new medicines, we question whether it is justified that the data are unavailable to independent scrutiny. On the basis of our findings, we reiterate calls that transparency policies need updating so that all IPD that inform results presented in a product label or underpin drug registration is immediately eligible for sharing,” the report said.