JAMA study finds cancer drug data still not available to trained researchers – Endpoints News


While data sharing has become more useful and relevant for researchers in recent years, a new report published in JAMA Oncology shows that the availability of clinical trial data on cancer drugs still lags behind for researchers. .

An audit by Australian researchers found that less than half of individual participant data from trials is shared with researchers.

The report, which was released on Thursday, noted that regulators’ and clinicians’ decisions on whether to approve and use new drugs are typically based on the results of pivotal clinical trials.

Although efforts to increase sharing have been spurred by the EMA and PhRMA, while acknowledging the importance of sharing individual participant data (IPD), the study shows that data from only 15% of trials clinics were available for sharing two years after publication, with no info, trading hands for oncology trials.

The current JAMA report acknowledged that since 2018 there has been substantial development of resources and systems to facilitate research using transparently shared IPDs as well as progress by the pharmaceutical industry to develop more policies for data sharing.

For the report, researchers reviewed all cancer drugs approved by the FDA between January 2011 and June 2021 and found that of the 304 trials conducted 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 the data available to researchers.

“Given that these trials form the basis of new drug safety and efficacy claims, we question whether the data is justified in not being available for independent review. Based on our findings, we reiterate calls that transparency policies need to be updated so that all DPIs that inform results presented on a product label or underpin a drug registration are immediately eligible for sharing,” indicates the report.

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