Self-Reported Conflicts of Interest of Authors, Trial Sponsorship, and the Interpretation of Editorials and Related Phase III Trials in Oncology

Bariani, Giovanni M.; Ferrari, A; Hoff, Paulo M.; Krzyzanowska, Monika K.; Riechelmann, Rachel P.

doi:10.1200/jco.2012.46.6706

Cited by 38 publications

(31 citation statements)

References 25 publications

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“…Several studies have examined this relation. [17][18][19][20][21][22][23][24][25] However, in most of these studies individual investigators' financial ties were not disentangled from the funding source for the study. These two variables, although related, are different.…”

Section: What This Study Addsmentioning

confidence: 99%

Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study

Ahn

Woodbridge

Abraham

et al. 2017

BMJ

136

109

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Objective To examine the association between the presence of individual principal investigators’ financial ties to the manufacturer of the study drug and the trial’s outcomes after accounting for source of research funding.Design Cross sectional study of randomized controlled trials (RCTs).Setting Studies published in “core clinical” journals, as identified by Medline, between 1 January 2013 and 31 December 2013.Participants Random sample of RCTs focused on drug efficacy.Main outcome measure Association between financial ties of principal investigators and study outcome.Results A total of 190 papers describing 195 studies met inclusion criteria. Financial ties between principal investigators and the pharmaceutical industry were present in 132 (67.7%) studies. Of 397 principal investigators, 231 (58%) had financial ties and 166 (42%) did not. Of all principal investigators, 156 (39%) reported advisor/consultancy payments, 81 (20%) reported speakers’ fees, 81 (20%) reported unspecified financial ties, 52 (13%) reported honorariums, 52 (13%) reported employee relationships, 52 (13%) reported travel fees, 41 (10%) reported stock ownership, and 20 (5%) reported having a patent related to the study drug. The prevalence of financial ties of principal investigators was 76% (103/136) among positive studies and 49% (29/59) among negative studies. In unadjusted analyses, the presence of a financial tie was associated with a positive study outcome (odds ratio 3.23, 95% confidence interval 1.7 to 6.1). In the primary multivariate analysis, a financial tie was significantly associated with positive RCT outcome after adjustment for the study funding source (odds ratio 3.57 (1.7 to 7.7). The secondary analysis controlled for additional RCT characteristics such as study phase, sample size, country of first authors, specialty, trial registration, study design, type of analysis, comparator, and outcome measure. These characteristics did not appreciably affect the relation between financial ties and study outcomes (odds ratio 3.37, 1.4 to 7.9).Conclusions Financial ties of principal investigators were independently associated with positive clinical trial results. These findings may be suggestive of bias in the evidence base.

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Section: What This Study Addsmentioning

confidence: 99%

Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study

Ahn

Woodbridge

Abraham

et al. 2017

BMJ

136

109

View full text Add to dashboard Cite

show abstract

“…The role of industry in oncology trials has expanded 8–10 and in 2011 industry funded over half of oncology clinical trials. 11 There has been concern about bias related to industry involvement in oncology trials from American Society of Clinical Oncology (ASCO) and others, 12,13 and ASCO has called for clinical trials to focus on overall survival (OS) as the most clinically meaningful outcome. 14,15 In addition, there have been broad calls for increased transparency, 16 and many journals now require authors of clinical trial reports to disclose the role of the funding source.…”

Section: Introductionmentioning

confidence: 99%

Impact of industry collaboration on randomised controlled trials in oncology

Linker

Yang

Roper

et al. 2017

European Journal of Cancer

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Background Industry funders can simply provide money or collaborate in trial design, analysis, or reporting of clinical trials. Our aim was to assess the impact of industry collaboration on trial methodology and results of randomized controlled trials (RCT). Methods We searched PubMed for oncology RCTs published May 2013 to December 2015 in peer-reviewed journals with impact factor > 5 requiring reporting of funder role. Two authors extracted methodologic (primary endpoint; blinding of the patient, clinician, and outcomes assessor; and analysis) and outcome data. We used descriptive statistics and two-sided Fisher exact tests to compare characteristics of trials with collaboration, with industry funding only, and without industry funding. Results We included 224 trials. Compared to those without industry funding, trials with collaboration used more placebo control (RR 3·59, 95% CI [1·88–6·83], p<·0001), intention-to-treat analysis (RR 1·32, 95% CI [1·04–1·67], p=·02), and blinding of patients (RR 3·05, 95% CI [1·71–5·44], p<·0001), clinicians (RR 3·36, 95% CI [1·83–6·16], p=<·001), and outcomes assessors (RR 3·03, 95% CI [1·57–5·83], p=·0002). They did not differ in use of overall survival as a primary endpoint (RR 1·27 95% CI [0·72–2·24]) and were similarly likely to report positive results (RR 1·11 95% CI [0·85–1·46], p=0·45). Studies with funding only did not differ from those without funding. Conclusions Oncology RCTs with industry collaboration were more likely to use some high-quality methods than those without industry funding, with similar rates of positive results. Our findings suggest that collaboration is not associated with trial outcomes and that mandatory disclosure of funder roles may mitigate bias.

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“…A study of oncology abstracts showed that the majority of studies on economic analyses with financial disclosures supported the sponsor's product (42). However, another study of published cancer clinical trials found that interpretation of results was not influenced by authors' financial relationships (43). A survey of clinical trial participants suggests most cancer patients are not concerned about researchers' financial ties with industry, although a substantial minority advocate for transparency and disclosure (44).…”

Section: Articlementioning

confidence: 99%

Distribution and Patterns of Industry-Related Payments to Oncologists in 2014

Marshall

Moy

Jackson

et al. 2016

JNCI J Natl Cancer Inst

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Background: Industry-physician collaboration is critical for anticancer therapeutic development, but financial relationships introduce conflicts of interest. We examined the specialty variation and context of physician payments and ownership interest among oncologists. Methods: We performed a population-based multivariable analysis of 2014 Open Payments reports of industry payments to US physicians matched to physician and practice data, including sex, specialty, practice location, and sole proprietor status. Payment data were aggregated per physician and compared by specialty (medical, radiation, surgical, and nononcology), and practice location linked with spending level (low, average, and high). Primary outcomes included likelihood, mean annual amount, and number of general payments. Secondary outcomes included likelihood of holding ownership interests and receipt of royalty/license payments. Estimates for each outcome were determined using multivariable models, including logistic regression for likelihood and linear regression with gamma distribution and log-link for value, adjusted for physician specialty, sex, sole proprietor status, and practice spending. All statistical tests were two-sided. Results: In 2014, there were 883 438 physicians, including 22 712 oncologists, licensed to practice in the United States. Among oncology specialties, 52.4% to 63.0% of physicians received a general payment in 2014, totaling $76 million, $4 million, and $5 million to medical, radiation, and surgical oncology, respectively. The median annual per-physician payment to medical oncologists was $632 (IQR ¼ 136-2500), compared with $124 (IQR ¼ 39-323) in radiation oncology and $250 (IQR ¼ 84-1369) in surgical oncology. After controlling for physician and practice characteristics, oncologists were 1.09 to 1.75 times as likely to receive a general payment compared with nononcologists (overall P < .001). There was a 67.6% difference (95% confidence interval [CI] ¼ 63.6 to 71.5, P < .001) in the mean annual value of payments between medical oncology and nononcology specialties (vs À92.7%, 95%CI ¼ À100.2 to À85.0, P < .001] for radiation oncology). Medical and radiation oncologists were more likely to hold ownership interest (adjusted OR ¼ 3.72, 95% CI ¼ 3.22 to 4.27, and 2.27, 95% CI ¼ 1.65 to 3.03, respectively, P < .001 both comparisons). Conclusions: In 2014, industry-oncologist financial relationships were common, and their impact on oncology practice should be further explored.

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Self-Reported Conflicts of Interest of Authors, Trial Sponsorship, and the Interpretation of Editorials and Related Phase III Trials in Oncology

Abstract: The interpretation of recently published phase III cancer trials by their authors or by editorialists was not influenced by financial relationships or industry sponsorship. Increased awareness of COI policies may have led to more integrity in cancer research reporting.

Cited by 38 publications

References 25 publications

Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study

Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study

Impact of industry collaboration on randomised controlled trials in oncology

Distribution and Patterns of Industry-Related Payments to Oncologists in 2014

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