Head-to-head randomized trials are mostly industry sponsored and almost always favor the industry sponsor

Flacco, Maria Elena; Manzoli, Lamberto; Boccia, Stefania; Capasso, Lorenzo; Aleksovska, Katina; Rosso, Annalisa; Scaioli, Giacomo; Vito, Corrado De; Siliquini, Roberta; Villari, Paolo; Ioannidis, John P. A.

doi:10.1016/j.jclinepi.2014.12.016

Cited by 151 publications

(118 citation statements)

References 52 publications

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“…18 Also, IS trials are generally larger and tend to have greater clinical impact. 19 Moreover, IS trials are more likely to adopt a noninferiority study design. Although this may allow drugs with similar clinical efficacy to enter the market, it also greatly helps to increase competition, leading to cheaper and safer drugs becoming available.…”

Section: Discussionmentioning

confidence: 99%

Impact of Funding Source on Clinical Trial Results Including Cardiovascular Outcome Trials

Riaz

Raza

Khan

et al. 2015

The American Journal of Cardiology

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Previous authors have suggested a higher likelihood for industry-sponsored (IS) studies to have positive outcomes than non-IS studies, though the influence of publication bias was believed to be a likely confounder. We attempted to control for the latter using a prepublication database to compare the primary outcome of recent trials based on sponsorship. We used the "advanced search" feature in the clinicaltrials.gov website to identify recently completed phase III studies involving the implementation of a pharmaceutical agent or device for which primary data were available. Studies were categorized as either National Institutes of Health (NIH) sponsored or IS. Results were labeled "favorable" if the results favored the intervention under investigation or "unfavorable" if the intervention fared worse than standard medical treatment. We also performed an independent literature search to identify the cardiovascular trials as a case example and again categorized them into IS versus NIH sponsored. A total of 226 studies sponsored by NIH were found. When these were compared with the latest 226 IS studies, it was found that IS studies were almost 4 times more likely to report a positive outcome (odds ratio [OR] 3.90, 95% confidence interval [CI] 2.6087 to 5.9680, p <0.0001). As a case example of a specialty, we also identified 25 NIH-sponsored and 215 IS cardiovascular trials, with most focusing on hypertension therapy (31.6%) and anticoagulation (17.9%). IS studies were 7 times more likely to report favorable outcomes (OR 7.54, 95% CI 2.19 to 25.94, p [ 0.0014). They were also considerably less likely to report unfavorable outcomes (OR 0.11, 95% CI 0.04 to 0.26, p <0.0001). In conclusion, the outcomes of large clinical studies especially cardiovascular differ considerably on the basis of their funding source, and publication bias appears to have limited influence on these findings. Ó 2015 Elsevier Inc. All rights reserved. (Am J Cardiol 2015;116:1944e1947) There has been a rising concern about industry-sponsored (IS) studies influencing the design and result of clinical trials. 1e5 This apprehension has been augmented by several observations of published IS studies yielding positive outcomes compared to less-impressive findings from independently funding investigations.

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Section: Discussionmentioning

confidence: 99%

Impact of Funding Source on Clinical Trial Results Including Cardiovascular Outcome Trials

Riaz

Raza

Khan

et al. 2015

The American Journal of Cardiology

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“…4 This exceeds Aberegg and colleagues' estimates of non-inferiority trials in general and raises the provocative questions of whether industry-sponsored noninferiority trials offer any value-aside from capturing market share.…”

Section: How Often Do Non-inferiority Trials Find Non-inferiority? Whmentioning

confidence: 90%

Non-Inferiority Trials in Medicine: Practice Changing or a Self-Fulfilling Prophecy?

Prasad

2017

J GEN INTERN MED

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“…While it was considered that the ideal arrangement would be for all research and drug development to be funded publicly and serving the most pressing needs, the current situation, where the vast majority of trials in high income countries are funded by the pharmaceutical industry (Atal, Trinquart, Porcher, & Ravaud, 2015;Flacco et al, 2015), was justified according to the following logic: R&D costs a lot; the pharmaceutical industry is necessary; and the pharmaceutical industry will need to make a profit. As one student remarked:…”

Section: Resignation To the Effects Of Structural Forcesmentioning

confidence: 99%

Conflicts of interest in neoliberal times: perspectives of Australian medical students

Mayes

Kerridge

Habibi

et al. 2016

Health Sociology Review

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In this paper we report on the findings from 6 focus groups conducted with Australian medical students. The focus groups discussed students' perceptions of conflicts of interest and the influence of commercial values in health care and medical education. Our research revealed that students were aware of a number of structural influences that affected the medical education they received and that had the potential to shape their attitudes and practices as they progressed in becoming a doctor. We found that the pressures of educational workload and anticipated career trajectories tended to have an individualising affect that limited the perceived possibility of collective action and response to structural influences. We interpreted these findings through the lens of neoliberal governmentality to articulate the way commercial interests are negotiated and normalised by medical students. Based on these findings, we suggest that medical education should not only explicitly alert students to effects of political and commercial influences on the health care system, but also encourage the collective agency of students and strategies that do not place unrealistic expectations on individuals to effect structural change.

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Head-to-head randomized trials are mostly industry sponsored and almost always favor the industry sponsor

Abstract: The literature of head-to-head RCTs is dominated by the industry. Industry-sponsored comparative assessments systematically yield favorable results for the sponsors, even more so when noninferiority designs are involved.

Cited by 151 publications

References 52 publications

Impact of Funding Source on Clinical Trial Results Including Cardiovascular Outcome Trials

Impact of Funding Source on Clinical Trial Results Including Cardiovascular Outcome Trials

Non-Inferiority Trials in Medicine: Practice Changing or a Self-Fulfilling Prophecy?

Conflicts of interest in neoliberal times: perspectives of Australian medical students

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