New research suggests that investigators involved in oncology trials sometimes fail to disclose payments from the pharmaceutical industry.
Researchers looked at clinical trials associated with cancer drugs recently approved in the United States and assessed whether funding was properly disclosed when the trial results were published in scientific journals.
The data showed that roughly a third of investigators failed to completely disclose payments from trial sponsors.
“We know that pharmaceutical companies sponsor trials of their own drugs. That’s not a surprise,” Cole Wayant, a DO/PhD student at Oklahoma State University in Tulsa, said in a statement. “But what is a surprise, and what warrants concern, is that this funding is often not disclosed in the publication of clinical trials that form the basis of FDA [Food and Drug Administration] approvals and clinical practice guidelines.”
Mr. Wayant and his colleagues conducted this research and reported the findings in a research letter published in JAMA Oncology.
The researchers began by searching the FDA Hematology/Oncology Approvals & Safety Notifications website for oncology drugs approved from Jan. 1, 2016, to Aug. 31, 2017.
The team then identified the published trials supporting these drug approvals and searched the Open Payments Database for industry payment data for each U.S.-based oncologist involved in the trials. Finally, the researchers compared the Open Payments data to the disclosure statements from the publications.
There were 344 authors of clinical trials associated with oncology drugs approved during the period studied. Most authors (76.5%) received at least one industry payment, and the total amount they received exceeded $216 million.
Nearly a third of the authors (32%, n = 110) did not fully disclose payments from a trial sponsor.
In all, the authors received about $6.3 million in general payments, such as speaking fees, and $1.7 million of that was undisclosed.
They received more than $500,000 in research payments, such as fees for study coordination, and more than $200,000 of that was undisclosed.
The authors received close to $210 million in associated research payments, such as grants, and about $78 million of that was undisclosed.
Mr. Wayant and his colleagues said these results suggest financial relationships between the pharmaceutical industry and oncology trial investigators “may be common, expensive, and frequently undisclosed.”
However, the research also suggests that Open Payments data could be used to ensure complete disclosure of industry payments.
The researchers reported having no financial disclosures.
SOURCE: Wayant C et al. JAMA Oncol. 2018 Aug 30. doi: 10.1001/jamaoncol.2018.3738.