A report published in the Journal of Clinical Oncology, online April 29, 2013 investigates whether increased participation by industry in cancer research has resulted in increased reporting of conflicts of interest (COI). The study’s objective was to test any association between authors’ conclusions and self-reported COI or trial sponsorship in cancer studies.
The report, entitled “Self-Reported Conflicts of Interest of Authors, Trial Sponsorship, and the Interpretation of Editorials and Related Phase III Trials in Oncology,” is co-authored by Giovanni M. Bariani, Anezka C.R. de Celis Ferrari, Paulo M. Hoff, and Rachel P. Riechelmann of the Instituto do Câncer do Estado de São Paulo, São Paulo, Brazil; and Monika K. Krzyzanowska, Princess Margaret Hospital, Toronto, Ontario, Canada.
According to the report abstract, editorials and related phase III trials published in six clinical oncology journals over the last 3.5 years were analyzed independently by two investigators who classified study conclusions according to the authors’ endorsement of the experimental therapy. Logistic regression multivariable models were used to assess predictors of favorable conclusions of editorialists and of phase III authors.
From January 2008 to October 2011, 1,485 articles were retrieved: 150 phase III trials and 150 editorials were eligible. Among the phase III trials, 82 (54.7%) had positive results, and 78 (52.0%) were entirely or partially funded by industry. Any COI were disclosed in 103 phase III trials (68.7%) and in 71 editorials (47.3%).
Multivariable analysis showed that phase III trial results were the only significant predictor for a positive conclusion by trial authors, and that sponsorship did not predict for positive conclusion by phase III authors. The only factor associated with positive conclusions by editorial authors was a positive conclusion by phase III trial authors.
Consequently, the scientific investigators conclude that interpretation of recently published phase III cancer trials by their authors or by editorialists was not influenced by financial relationships or industry sponsorship, and deduce that increased awareness of COI policies may have led to more integrity in cancer research reporting.
However, Genevra Pittman of Reuters Health reports that the Harvard School of Public Health’s Dr. Aaron Kesselheim, who has also examined the COI in cancer research reporting issue, notes that other studies have arrived at the opposite conclusion.
On the other hand, Ms. Pittman cites Dr. David Johnson, head of internal medicine at the University of Texas Southwestern School of Medicine in Dallas commenting: “I would agree with the authors that based on their study, the financial disclosure information that authors are now required to provide for most credible medical journals does impact their writing (and) how they present data,” adding that “All transparency can be beneficial,” but that doctors should still be cautious about new research and closely evaluate how studies were conducted – whether or not they’re funded by a drug company.
Dr. Johnson is co-author of an American Society of Clinical Oncology article, “Physician and Stakeholder Perceptions of Conflict of Interest Policies in Oncology,” published online before print March 25, 2013 (doi: 10.1200/JCO.2012.47.5475) and in the Journal of Clinical Oncology http://jco.ascopubs.org/JCO May 1, 2013 vol. 31 no. 13 1677-1682.
The article Abstract notes that “the landscape of managing potential conflicts of interest (COIs) has evolved substantially across many disciplines in recent years, but rarely are the issues more intertwined with financial and ethical implications than in the health care setting. Cancer care is a highly technologic arena, with numerous physician-industry interactions. The American Society of Clinical Oncology (ASCO) recognizes the role of a professional organization to facilitate management of these interactions and the need for periodic review of its COI policy (Policy).”
Two surveys were conducted, the first asking ASCO members to estimate opinions of the Policy as it relates to presentation of industry-sponsored research, with respondents classified as consumers or producers of research material based on demographic responses. A similar survey solicited opinions of nonphysician stakeholders, including patients with cancer, survivors, family members, and advocates.
The ASCO survey was responded to by 1,967 members, 80% producers, 20% consumers. Most respondents (93% of producers; 66% of consumers) reported familiarity with the Policy, but only a small proportion regularly evaluated COIs for presented research. Members favored increased transparency about relationships over restrictions on presentations of research.
The authors conclude that COI policies are an important and relevant topic among physicians and patient advocates, and that methods to simplify the disclosure process, improve transparency, and facilitate responsiveness are critical for COI management.