Conflict of interest: Clinical trial authors not fully disclosing financial relationships with sponsors

13-Sep-2018 - Last updated on 17-Sep-2018 at 08:27 GMT

(Image: Getty/Michail_Petrov-96)

Undisclosed pharmaceutical industry payments to authors of oncology clinical trials published in scientific journals raise concern around credibility and trustworthiness, according to a recent report.

The report, published in the journal JAMA Oncology, specifically focused on clinical trials testing new cancer drugs. According to the report, a substantial proportion of pharmaceutical industry payments to authors of oncology clinical trials published in major scientific journals are not disclosed.

The researchers explained that a financial conflict of interest (FCOI) may affect clinical trial conduct and reporting – and the presence of FCOIs in clinical trials of oncology drugs that receive US Food and Drug Administration (FDA) approval “is of particular concern, because these trials may change the trajectory of cancer care.”

“These trials also generate high-impact factor publications, prestige for authors, revenue for the pharmaceutical companies, and newsworthy headlines,” according to the researchers.

Cole Wayant, PhD, a researcher at Oklahoma State University and co-author of the report, told us the basis for the research was the importance of new FDA-approved drugs for oncologists and patients with cancer.

“These new drugs often improve survival outcomes, but may also be associated with adverse events and high costs,” Wayant explained. “Therefore, the disclosure of financial relationships in the trials that underpin the FDA drug approvals is essential for transparency.”

“Transparency allows prescribers to distinguish between evidence that is truly strong and evidence motivated by vested interests,” added co-author Erick Turner, MD, associate professor of psychiatry in the OHSU School of Medicine and senior scholar with the Center for Ethics in Health Care at OHSU in Portland, Oregon.

“Hopefully, our study with bring an increased awareness of financial relationships with industry and promote complete disclosure of all financial relationships,” added Wayant. “This is important for reasons previously mentioned – transparency between trial authors and practicing oncologists is essential.”

Financial disclosure in publication of clinical trials
Infogram

To determine payments to oncologists who authored studies the researchers examined the federal Open Payments Database.

The authors compared disclosure of financial conflict of interest in clinical trials published in six scientific journals: The New England Journal of Medicine, The Lancet, The Lancet Oncology, The Lancet Haematology, the Journal of Clinical Oncology, and JAMA Oncology.

For Wayant, the key takeaway is the frequency of undisclosed conflicts. “We found that almost a third of included oncologist-authors did not completely disclose their financial relationships with the trial sponsor,” he explained.

Turner said he found it surprising that the journals with the highest proportion of undisclosed conflicts were the journals with “the biggest names.”

To improve credibility and trustworthiness, Turner noted that industry should educate collaborating authors about the importance of full disclosure.

Source: JAMA Oncology
DOI: 10.1001/jamaoncol.2018.3738
Financial Conflicts of Interest Among Oncologist Authors of Reports of Clinical Drug Trials
Authors: Wayant C, Turner E, Meyer C, Sinnett P, Vassar M.