JAMA study finds cancer drug data still largely unavailable to qualified researchers – Endpoints News

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As data sharing has become more helpful and relevant to researchers in recent years, a new report in JAMA Oncology shows that the availability of clinical trial data on cancer drugs to researchers is still lagging behind.

A review by Australian researchers found that less than half of individual participant data from studies is shared with researchers.

The report, released Thursday, found that decisions by regulators and clinicians about the approval and use of new drugs are typically based on evidence from pivotal clinical trials.

While efforts to increase sharing have been driven by the EMA and PhRMA and the importance of sharing individual participant data (IPD) has been recognized, the study shows that data from only 15% of clinical trials are available two years after publication for the transfers were available. with no information exchanging hands for oncology trials.

The current JAMA report recognizes that since 2018 there has been a significant development of resources and systems to facilitate research using transparently shared IPD, as well as advances by the pharmaceutical industry in developing further guidelines for data sharing.

For the report, the researchers looked at all cancer drugs approved by the FDA between January 2011 and June 2021 and found that of the 304 studies conducted during the window, only 45% supported the sharing of IPD with independent ones researchers came into question.

The study also found that companies like AbbVie, Bayer, Gilead and Takeda had less than 50% of their oncology trials available for IPD exchange. But others like Astellas, Bristol Myers Squibb, GSK, Merck, and Teva had less than 10% available for sharing. Drugs like nivolumab, pembrolizumab, and pomalidomide also have less than 10% of the data available to researchers.

“As these studies form the basis of safety and efficacy claims for new medicines, we question the justification for the data not being available for independent review. Based on our findings, we reiterate the call for transparency guidelines to be updated so that any IPD informing results presented on a product label or underpinning drug registration can be released immediately,” the report reads.

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