Methods to Mitigate Industry Influence in Industry Sponsored Research

Abstract

Medical and surgical research has always had a longstanding relationship with industry-based funding from sources, such as drug and device companies. Concerns exist surrounding the association between funding sources, outcome from studies and publication bias. Studies demonstrating increased odds ratios associated with positive results in industry sponsored studies across medicine have stimulated Cochrane reviews, literature reviews and other articles to examine this relationship further. In spine surgery in particular, studies with positive results have an odds ratio of 3.3 of being published. This article discusses the biases associated with industry sponsorship, possible ways to reduce such biases and ways to improve transparency in research relationships. This article explores the types of bias that can be encountered at different stages of research including previous trials in spine surgery. The means of improving transparency including the Physician Payment Sunshine Act of 2010 and International Committee of Medical Journal Editors (ICJME) accreditation are discussed. We recognize that physicians undertaking industry sponsored research should be protected and not be liable to perverse incentives. We conclude that mitigating bias in industry sponsored research is a multistep process and needs a multifaceted approach. The main beneficiary of research should be patients and as such a collective effort from medical professionals, health care institutions, journals and industry should approach research, and publications with that in mind.

Clinical Trial Quality Assessment in Adult Spinal Surgery: What Do Publication Status, Funding Source, and Result Reporting Tell Us?

“… 9 Industry-sponsored research can benefit the field of spine surgery, but it can also bias both publication of results as well as presentation of data and its interpretation. 16 In general, industry-sponsored research is associated with more favorable efficacy results, more favorable study conclusions, and lower agreement between study results and conclusions when compared to non–industry-funded research. 17 The physician tasked with interpreting and applying clinical research to treatment decisions must be aware of these associations.…”

Rules of engagement: Promoting academic-industry partnership in the era of digital pathology and artificial intelligence

“…publication bias). 7 , 24 , 25 , 26 Misappropriation and malevolence arising from various partnerships have sometimes eroded public trust in research. 27 There has also been notable gender disparity in AIPs, where female physicians in some fields have received fewer and lower industry payments.…”

A Loss of Decency – and a Call for Voluntary Academic Integrity

“…Fostering functional ties of health care providers to industry for the greater good has clearly shown itself to be a major driver for positive advances in health care. 1 Due to the dimension of financial incentives attainable and the potential for major adverse effects on patient health and well-being of health care systems some regulatory oversight is obviously desirable. Aside from blatant fraudulent intent, perhaps one of the most underrecognized aspects of commercially funded studies is a confirmation bias as shown in the significantly higher propensity for reporting positive outcomes with industry sponsored studies compared to nonfunded studies (78.9% vs 63.3% in one study and 98 vs 88% in another).…”

“… 2 , 3 Of course, author bias from direct commercial interests remains one of the most prevalent concerns in a lucrative field like Spine surgery as shown repeatedly over the last 30 years. 1 In general, we sadly have to assume that there is a continued strong and persistent underreporting of financial relationships with industrial entities despite near ubiquitous requests for declaration of conflicts of interest. In a recent study of 5070 articles in Orthopaedic and General surgery Trauma literature only 16.6% of authors disclosed their financial conflicts correctly, with 26.3% of Orthopaedic Surgeons and only 4.8% of General surgeons disclosing their conflicts as requested.…”

“…Hopefully ‘intentional nonreporting’ is rare, but exact numbers on this most concerning form of commercially motivated academic misconduct are hard to come by. 1 An improvement in transparency has been brought on in the greater advancement of legislative efforts in some countries to force companies to make public payments to health care practitioners. In example, the ‘Open payments’ databank that started in the USA following the ‘ Sunshine act’ in the Fall of 2013 provides such a resource for the benefit of the public.…”