Industry Collaboration and Primary Guest Authorship of High-Impact Randomized Clinical Trials: A Cross-Sectional Study

Roper, Nitin; Korenstein, Deborah

doi:10.1007/s11606-015-3299-1

Cited by 11 publications

(6 citation statements)

References 13 publications

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“…15,16 Industry may also influence which findings should be emphasized in the discussion. 17 However, it is important to note that industry should not be vilified.…”

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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“…15,16 Industry may also influence which findings should be emphasized in the discussion. 17 However, it is important to note that industry should not be vilified.…”

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

View full text Add to dashboard Cite

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“…This study suggests that many authors do not substantially participate in the design, analysis or writing of publications that carry their name. This leaves us with the question as to what extent authorship is honorary or simply a reward for enrolling patients in a clinical trial, or meant to give the study and the product credibility through the inclusion of ‘thought leaders’ as authors . It is highly likely many ‘authors’ do not meet the criteria put forward by the International Committee of Medical Journal Editors (Appendix).…”

mentioning

confidence: 99%

‘Whoever has will be given more’ (Matthew 13:12): authorship of systematic reviews and clinical trials in the biological age

Stern

2017

Br J Dermatol

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“…One consequence of these pressures is the phenomenon of “guest authors”: celebrated “key opinion leaders” who do not contribute to trial design or execution, or manuscript drafting, but whose name lends gravitas to the study. The International Committee of Medical Journal Editors has attempted to avoid this by strict definitions of authorship; nonetheless, a recent study showed that 13% of industry studies, with collaboration, consisted of guest authors as either first or last authors . The current International Committee of Medical Journal Editors (ICMJE) criteria for authorship requires substantial contributions to trial design, manuscript drafting, approval of the final manuscript, and agreement to be accountable .…”

Section: Frequency Of Authorship Of Phase 3 Trials In Multiple Sclerosismentioning

confidence: 99%

Authorship of phase 3 trials in multiple sclerosis

Coles

2018

Annals of Neurology

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Industry Collaboration and Primary Guest Authorship of High-Impact Randomized Clinical Trials: A Cross-Sectional Study

Cited by 11 publications

References 13 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

‘Whoever has will be given more’ (Matthew 13:12): authorship of systematic reviews and clinical trials in the biological age

Authorship of phase 3 trials in multiple sclerosis

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