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Financial disclosure lacking in publication of clinical trials

A substantial proportion of pharmaceutical industry payments to authors of oncology clinical trials published in major scientific journals are not disclosed, research shows. The publications focused on clinical trials that tested new cancer drugs.

Authors of the research letter examined the federal Open Payments Database to determine payments to oncologists who authored studies in high-impact journals. They then cross-checked the information to determine whether the authors properly disclosed the funding when the results of their clinical trials were published in scientific journals. Depending on the journal, almost half of total funding was not disclosed.

"It's the honour system," said co-author Dr Erick Turner, associate professor of psychiatry in the Oregon Health & Science University (OHSU) School of Medicine and senior scholar with the Centre for Ethics in Health Care at OHSU in Portland, Oregon. "The journals ask the authors to make these disclosures, but there's no legal force behind it."

Previous studies have investigated funding disclosures among the authors of clinical practice guidelines. However, this is the first study to examine financial conflict of interest in the publication of clinical trials that underpin US Food and Drug Administration (FDA) approval of new oncology drugs.

Payments from pharmaceutical companies have been shown to change physician prescribing practices, researchers noted.

"We know that pharmaceutical companies sponsor trials of their own drugs. That's not a surprise," said lead author Dr Cole Wayant, researcher at Oklahoma State University. "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 approvals and clinical practice guidelines."

The researchers identified 344 oncologist-authors of clinical trials associated with oncology drugs approved between 1 January, 2016, and 31 August, 2017. Cumulatively, the 344 oncologist authors received a total of $216m in four categories of payments: speaking fees and other general payments; research for study coordination; research grants, and ownership through stock payments.

The authors then compared disclosure of financial conflict of interest in clinical trials published in six high-impact scientific journals: The New England Journal of Medicine, The Lancet, The Lancet Oncology, The Lancet Haematology, the Journal of Clinical Oncology, and JAMA Oncology. Almost a third of the oncologist-authors (a total of 110) did not fully disclose payments, the study found.

"In clinical trials of FDA-approved oncology drugs, bias, either real or potential, is more concerning because these oncology drugs are often associated with marginal improvement in survival but exorbitant costs," the authors wrote.

In medical research, a financial conflict of interest (FCOI) may affect the conduct and reporting of clinical trials.1 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. The primary objective of this investigation was to quantify the prevalence and magnitude of industry-oncologist financial relationships in trials of oncology drugs that received FDA approval. The secondary objective was to identify the proportion of undisclosed FCOIs among oncologist authors.

Cole Wayant, Erick Turner, Chase Meyer, Philip Sinnett, Matt Vassar

[link url=""]Oregon Health & Science University material[/link]
[link url=""]JAMA Oncology abstract[/link]

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