A Review of Industry Funding in Randomized Controlled Trials Published in the Neurosurgical Literature—The Elephant in the Room

Khan, Nickalus R.; Saad, Hassan; Oravec, Chesney S; Rossi, Nicholas; Nguyen, Vincent; Venable, Garrett T.; Lillard, Jock C; Patel, Prayash; Taylor, Douglas R.; Vaughn, Brandy; Kondziolka, Douglas; Barker, Fred G.; nd, L Madison Michael; Klimo, Paul

doi:10.1093/neuros/nyx624

Cited by 17 publications

(7 citation statements)

References 54 publications

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“…18 Several studies have shown that industry funded randomized controlled trials show a higher likelihood of positive results. [27][28][29][30] These findings are particularly concerning, given that they make up the sample of primary studies included in systematic reviews. Further, a study found that only 7% of meta-analyses reported the funding sources of the primary studies included for synthesis, of which the majority were industry funded.…”

Section: Discussionmentioning

confidence: 99%

Authorial Conflicts of Interest and Sponsorship in Systematic Reviews and Meta-Analyses on Psoriasis

Kee

Greenough

Anderson

et al. 2021

Journal of Psoriasis and Psoriatic Arthritis

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Background: Because industry influence – in the form of study sponsorship and authorial conflicts of interest (COI) – can bias the results and conclusions of systematic reviews, there is a need to understand their role in systematic reviews, particularly for common conditions like psoriasis. Objectives: This study identifies conflicts of interest and industry-author relationships in systematic reviews on psoriasis treatment. Methods: Consistent with our cross-sectional design, we searched MEDLINE and Embase for systematic reviews and meta-analyses focused on psoriasis treatment. We then performed a subgroup analysis to determine further industry ties within the systemic reviews funded by industry. Results: Our study consisted of 27 systematic reviews and meta-analyses by 146 researchers. We found that 22 (81.5%) of the included systematic reviews contained at least 1 conflicted author. Six authors (of 47; 4.1%) disclosed all COI within the systematic review, 23 (of 47; 15.7%) partially disclosed COI but were also found to have undisclosed COI, and 18 (of 47; 12.3%) did not disclose any COI. Thirteen (of 22; 59.1%) contained narratives that favored the treatment group and 19 (of 22; 86.4%) reported conclusions favoring the treatment group. Importantly, 3 systematic reviews were industry-sponsored. In terms of our subgroup analysis, we found several additional industry ties within the primary studies. Conclusion: Our study calls attention to conflicts of interest, industry sponsorship, and their influence on research outcomes in systematic reviews and meta-analyses. Further, we provide examples of how specific industry ties can influence systematic reviews and recommendations for reporting.

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Section: Discussionmentioning

confidence: 99%

Authorial Conflicts of Interest and Sponsorship in Systematic Reviews and Meta-Analyses on Psoriasis

Kee

Greenough

Anderson

et al. 2021

Journal of Psoriasis and Psoriatic Arthritis

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“…To address this, many scientists have opted to obtain funding from industry. Khan et al reviewed 110 RCTs published from 1981 to 2017 in three leading neurosurgical journals [28] and found that 36.4% (40 articles) stated that industry funding was provided. Of the RCTs in which industry sponsorship was present, 78% (31 out of 40) had a conclusion in favor of the new drug, device/implant, or surgical technique compared to 12.8% (nine out of 70) of RCTs without industry sponsorship.…”

Section: Trial Implementation Fundingmentioning

confidence: 99%

Randomized controlled trials in neurosurgery

Takroni

Sharma

Reddy

et al. 2022

Surgical Neurology International

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Randomized controlled trials (RCTs) have become the standard method of evaluating new interventions (whether medical or surgical), and the best evidence used to inform the development of new practice guidelines. When we review the history of medical versus surgical trials, surgical RCTs usually face more challenges and difficulties when conducted. These challenges can be in blinding, recruiting, funding, and even in certain ethical issues. Moreover, to add to the complexity, the field of neurosurgery has its own unique challenges when it comes to conducting an RCT. This paper aims to provide a comprehensive review of the history of neurosurgical RCTs, focusing on some of the most critical challenges and obstacles that face investigators. The main domains this review will address are: (1) Trial design: equipoise, blinding, sham surgery, expertise-based trials, reporting of outcomes, and pilot trials, (2) trial implementation: funding, recruitment, and retention, and (3) trial analysis: intention-to-treat versus as-treated and learning curve effect.

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“…Thomas et al looked at reporting quality of long-term weight loss trials and found that industry funded studies were better [ 60 ]. Kan et al examined the association between industry funding and “positive trials” (trials reporting a significant intervention effect) and found that industry funding was highly predictive of a positive trial [ 61 ]. This finding is similar to that of a recent Cochrane Methodology Review by Hansen et al [ 62 ] Journal characteristics: Certain journals’ characteristics may influence the study design, analysis or reporting.…”

Section: Main Textmentioning

confidence: 99%

A tutorial on methodological studies: the what, when, how and why

Mbuagbaw

Lawson

Puljak

et al. 2020

BMC Med Res Methodol

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Background Methodological studies – studies that evaluate the design, analysis or reporting of other research-related reports – play an important role in health research. They help to highlight issues in the conduct of research with the aim of improving health research methodology, and ultimately reducing research waste. Main body We provide an overview of some of the key aspects of methodological studies such as what they are, and when, how and why they are done. We adopt a “frequently asked questions” format to facilitate reading this paper and provide multiple examples to help guide researchers interested in conducting methodological studies. Some of the topics addressed include: is it necessary to publish a study protocol? How to select relevant research reports and databases for a methodological study? What approaches to data extraction and statistical analysis should be considered when conducting a methodological study? What are potential threats to validity and is there a way to appraise the quality of methodological studies? Conclusion Appropriate reflection and application of basic principles of epidemiology and biostatistics are required in the design and analysis of methodological studies. This paper provides an introduction for further discussion about the conduct of methodological studies.

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A Review of Industry Funding in Randomized Controlled Trials Published in the Neurosurgical Literature—The Elephant in the Room

Abstract: Industry funding was associated with a much greater chance of positive findings in RCTs published in neurosurgical journals. Further efforts are needed to define the relationship between the authors and financial sponsors of neurosurgical research and explore the reasons for this finding.

Cited by 17 publications

References 54 publications

Authorial Conflicts of Interest and Sponsorship in Systematic Reviews and Meta-Analyses on Psoriasis

Authorial Conflicts of Interest and Sponsorship in Systematic Reviews and Meta-Analyses on Psoriasis

Randomized controlled trials in neurosurgery

A tutorial on methodological studies: the what, when, how and why

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