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

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

Research output: Contribution to journalReview article

Abstract

BACKGROUND: The potential influence of industry funding on outcomes in neurosurgical research is a concern. OBJECTIVE: To analyze the role of industry sponsorship of randomized controlled trials (RCTs) published exclusively in 3 major North American neurosurgical journals. METHODS: Our primary objective was to determine whether an association exists between study conclusion(s) in favor of industry sponsored drugs, devices/implants, or surgical techniques and industry sponsorship. The secondary objective was to describe the quality/quantity of these neurosurgical RCTs. RESULTS: A total of 110 RCTs were analyzed, the majority were published in the Journal of Neurosurgery (85%) and were international in origin (55%). The most common subspecialty was spine (n = 29) and drug study was the most common type (n = 49). Overall qualitywas good with median Jadad and Detsky scores of 4 (range, 1-5) and 18 (range, 8-21), respectively. There was a statistically significant difference in RCTs with industry funding (31/40, 78%) versus those without (9/70, 13%) that published a favorable conclusion of the new drug, device/implant, or surgical technique (odds ratio [OR], 23.35; P<.0001).Multiple binomial logistic regression analysis identified number of authors as mildly protective (OR, 0.79; 95% confidence interval, 0.69-0.91; P = .001) and industry funding strongly predictive (OR, 12.34; 95% confidence interval, 2.97-51.29; P = .001) of a positive trial. CONCLUSION: 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.

Original languageEnglish (US)
Pages (from-to)890-897
Number of pages8
JournalClinical neurosurgery
Volume83
Issue number5
DOIs
StatePublished - Nov 1 2018

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Industry
Randomized Controlled Trials
Drug Implants
Odds Ratio
Confidence Intervals
Equipment and Supplies
Neurosurgery
Research
Spine
Logistic Models
Regression Analysis
Pharmaceutical Preparations

All Science Journal Classification (ASJC) codes

  • Surgery
  • Clinical Neurology

Cite this

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 N.; Kondziolka, Douglas; Barker, Fred G.; Michael, Lattimore; Klimo, Paul.

In: Clinical neurosurgery, Vol. 83, No. 5, 01.11.2018, p. 890-897.

Research output: Contribution to journalReview article

Khan, NR, Saad, H, Oravec, CS, Rossi, N, Nguyen, V, Venable, GT, Lillard, JC, Patel, P, Taylor, DR, Vaughn, BN, Kondziolka, D, Barker, FG, Michael, L & Klimo, P 2018, 'A Review of Industry Funding in Randomized Controlled Trials Published in the Neurosurgical Literature - The Elephant in the Room', Clinical neurosurgery, vol. 83, no. 5, pp. 890-897. https://doi.org/10.1093/neuros/nyx624
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 N. ; Kondziolka, Douglas ; Barker, Fred G. ; Michael, Lattimore ; Klimo, Paul. / A Review of Industry Funding in Randomized Controlled Trials Published in the Neurosurgical Literature - The Elephant in the Room. In: Clinical neurosurgery. 2018 ; Vol. 83, No. 5. pp. 890-897.
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abstract = "BACKGROUND: The potential influence of industry funding on outcomes in neurosurgical research is a concern. OBJECTIVE: To analyze the role of industry sponsorship of randomized controlled trials (RCTs) published exclusively in 3 major North American neurosurgical journals. METHODS: Our primary objective was to determine whether an association exists between study conclusion(s) in favor of industry sponsored drugs, devices/implants, or surgical techniques and industry sponsorship. The secondary objective was to describe the quality/quantity of these neurosurgical RCTs. RESULTS: A total of 110 RCTs were analyzed, the majority were published in the Journal of Neurosurgery (85{\%}) and were international in origin (55{\%}). The most common subspecialty was spine (n = 29) and drug study was the most common type (n = 49). Overall qualitywas good with median Jadad and Detsky scores of 4 (range, 1-5) and 18 (range, 8-21), respectively. There was a statistically significant difference in RCTs with industry funding (31/40, 78{\%}) versus those without (9/70, 13{\%}) that published a favorable conclusion of the new drug, device/implant, or surgical technique (odds ratio [OR], 23.35; P<.0001).Multiple binomial logistic regression analysis identified number of authors as mildly protective (OR, 0.79; 95{\%} confidence interval, 0.69-0.91; P = .001) and industry funding strongly predictive (OR, 12.34; 95{\%} confidence interval, 2.97-51.29; P = .001) of a positive trial. CONCLUSION: 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.",
author = "Khan, {Nickalus R.} and Hassan Saad and Oravec, {Chesney S.} and Nicholas Rossi and Vincent Nguyen and Venable, {Garrett T.} and Lillard, {Jock C.} and Prayash Patel and Taylor, {Douglas R.} and Vaughn, {Brandy N.} and Douglas Kondziolka and Barker, {Fred G.} and Lattimore Michael and Paul Klimo",
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T1 - A Review of Industry Funding in Randomized Controlled Trials Published in the Neurosurgical Literature - The Elephant in the Room

AU - Khan, Nickalus R.

AU - Saad, Hassan

AU - Oravec, Chesney S.

AU - Rossi, Nicholas

AU - Nguyen, Vincent

AU - Venable, Garrett T.

AU - Lillard, Jock C.

AU - Patel, Prayash

AU - Taylor, Douglas R.

AU - Vaughn, Brandy N.

AU - Kondziolka, Douglas

AU - Barker, Fred G.

AU - Michael, Lattimore

AU - Klimo, Paul

PY - 2018/11/1

Y1 - 2018/11/1

N2 - BACKGROUND: The potential influence of industry funding on outcomes in neurosurgical research is a concern. OBJECTIVE: To analyze the role of industry sponsorship of randomized controlled trials (RCTs) published exclusively in 3 major North American neurosurgical journals. METHODS: Our primary objective was to determine whether an association exists between study conclusion(s) in favor of industry sponsored drugs, devices/implants, or surgical techniques and industry sponsorship. The secondary objective was to describe the quality/quantity of these neurosurgical RCTs. RESULTS: A total of 110 RCTs were analyzed, the majority were published in the Journal of Neurosurgery (85%) and were international in origin (55%). The most common subspecialty was spine (n = 29) and drug study was the most common type (n = 49). Overall qualitywas good with median Jadad and Detsky scores of 4 (range, 1-5) and 18 (range, 8-21), respectively. There was a statistically significant difference in RCTs with industry funding (31/40, 78%) versus those without (9/70, 13%) that published a favorable conclusion of the new drug, device/implant, or surgical technique (odds ratio [OR], 23.35; P<.0001).Multiple binomial logistic regression analysis identified number of authors as mildly protective (OR, 0.79; 95% confidence interval, 0.69-0.91; P = .001) and industry funding strongly predictive (OR, 12.34; 95% confidence interval, 2.97-51.29; P = .001) of a positive trial. CONCLUSION: 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.

AB - BACKGROUND: The potential influence of industry funding on outcomes in neurosurgical research is a concern. OBJECTIVE: To analyze the role of industry sponsorship of randomized controlled trials (RCTs) published exclusively in 3 major North American neurosurgical journals. METHODS: Our primary objective was to determine whether an association exists between study conclusion(s) in favor of industry sponsored drugs, devices/implants, or surgical techniques and industry sponsorship. The secondary objective was to describe the quality/quantity of these neurosurgical RCTs. RESULTS: A total of 110 RCTs were analyzed, the majority were published in the Journal of Neurosurgery (85%) and were international in origin (55%). The most common subspecialty was spine (n = 29) and drug study was the most common type (n = 49). Overall qualitywas good with median Jadad and Detsky scores of 4 (range, 1-5) and 18 (range, 8-21), respectively. There was a statistically significant difference in RCTs with industry funding (31/40, 78%) versus those without (9/70, 13%) that published a favorable conclusion of the new drug, device/implant, or surgical technique (odds ratio [OR], 23.35; P<.0001).Multiple binomial logistic regression analysis identified number of authors as mildly protective (OR, 0.79; 95% confidence interval, 0.69-0.91; P = .001) and industry funding strongly predictive (OR, 12.34; 95% confidence interval, 2.97-51.29; P = .001) of a positive trial. CONCLUSION: 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.

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