Fewer Than Half of Cancer Trials Shared Individual Participant Data in Past Decade
Only 45 percent of cancer drug trials made their individual participant data (IPD) available to other qualified researchers over the past 10 years, according to a new study.
Researchers from the University of South Australia, Bond University, Flinders University and Duke University Medical Center first identified all cancer drugs approved by the FDA between Jan. 1, 2011, and June 30, 2021, then assembled a list of trials that had their results summarized in the drugs’ product labels. They found that although sharing of IPD has notably improved in the past five years, more than half (55 percent) of the 304 trials evaluated did not have their IPD made accessible to researchers, according to results published in JAMA Oncology.
They also looked at sponsors and found that data-sharing rates varied significantly among them. The most common reason for keeping IPD under wraps was that long-term follow-up data were being gathered (53 percent of trials).
Of the top 20 sponsors by revenue, AbbVie, Bayer, Gilead Sciences and Takeda have less than half of their cancer trial IPD available for sharing. And in what the researchers called “a missed opportunity,” Astellas Pharma, Bristol Myers Squibb, GlaxoSmithKline, MSD and Teva shared less than 10 percent.
“When participants commit to these trials, they are generally advised and reasonably expect that, although they may not personally benefit from their participation, the knowledge gained will contribute to better care for future patients. Our findings indicate that this commitment to participants in oncology trials is not yet being fully met,” the researchers said. “Data accessibility would be substantially improved if, at the time of FDA registration of a medicine, all data that support the registration were made available.”
Based on the findings, the researchers offer three recommendations to sponsors: join PhRMA and/or the European Federation of Pharmaceutical Industries and Associations and create a data-sharing policy; establish IPD-sharing procedures outside of the company to avoid internal conflicts of interest; and establish a policy that states all IPD underlying results on a product label will be immediately eligible for sharing.
Read the full study results here: https://bit.ly/3QfFMjy.