Sponsor Influences on the Quality and Independence of Health Research Proceedings of a Workshop (2023) / Chapter Skim
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5 Considering Models, Processes, and Principles to Protect Research Independence and Quality
5 Considering Models, Processes, and Principles to Protect Research Independence and Quality
Pages 53-78
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Vincent Cogliano, deputy director for scientific programs at the California EPA Office of Environmental Health Hazard Assessment, spoke about protecting the scientific integrity1 of the International Agency for Research on Cancer (IARC) Monographs.
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• Public sector innovation in drug development and biopharmaceutical research prioritizes equity, affordability, access, and transparency compared to indus try-funded research. (Grundy)
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Studies have found that disclosure of funding sources with a COI may make some physicians less willing to prescribe the drugs in the paper, regardless of the scientific rigor of the study (Kesselheim et al., 2012)
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"Once we have disclosed, we think we have dealt with our moral obligations with respect to COIs, and rationalization can crowd out more effective solutions than managing COIs," she said. She does not recommend disclosure as a solution to managing COIs unless it leads people to reject conflicted funding themselves and improve the quality of their advice.
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For example, if a hospital policy bans pharmaceutical representatives from interacting with physicians in their hospitals and ends free lunches, physicians who understand deep professionalism will also reject walking across the street for the free lunches that the company now offers in a hotel conference room. Even though the policy does not regulate behavior outside of the hospital, those with deep professionalism will understand and internalize the principles and values of self-regulation and nurture their values repeatedly with active practice (Sah, 2022)
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The first item on her list of concerns is the text in a paper indicating evidence of the sponsor involvement study execution, such as choosing the clinical trial sites and investigators, or where the sponsor can adjudicate end points or help analyze the data. Often, she said, the end points in studies are not objective -- such as death -- but are soft and require adjudication.
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She wondered if journals should restrict the sponsor's role in submissions just as papers published in leading medical journals have an absolute clinical trial registration requirement. She noted that JAMA had a 2005 policy that any paper with a sponsor involved in the data analysis also had to have an independent statistical analysis, and it is worth exploring if the policy was effective in improving objectivity.
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Biopharmaceutical companies and medical device manufacturers, as previous speakers noted, are involved in clinical trials in a variety of ways, from providing free study drugs to conducting trials and writing and publishing trial results. To illustrate the extent to which industry sponsors clinical trials, Grundy cited work that characterized trials initiated between 2006 and 2013 and registered in the WHO Clinical Trials Registry Platform and sorted them by country and World Bank income category (see Figure 5-1)
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FIGURE 5-1 The dominance of industry sponsors in biomedical clinical trials. 61 SOURCE: Presented by Quinn Grundy on December 16, 2022 (Atal et al., 2015)
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They rely on industry-sponsored, -conducted, and -curated research and information for clinical practice," Grundy said. Her perspective as a nurse is that this applies to not just drugs or surgical devices, but a range of medical products and devices used in day-to-day care.
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To her knowledge, the Cochrane Collaboration database of systematic reviews is the only source of biomedical publications that prohibits industry funding of the review and British Medical Journal is the only other example that will not accept papers reporting on tobacco industry-funded research.5 Switching gears, Grundy discussed a study she and her colleagues conducted that offers insights into how to reimagine research conduct such that the public sector takes a leading role. During the early days of the pandemic, convalescent plasma from people exposed to COVID-19 emerged as a promising stopgap measure while the world waited for vaccines and other treatment options to become available.
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Another feature of these publicly funded trials that was qualitatively different was their reliance on public infrastructure, such as NIH and trial networks established for other diseases. Grundy noted that the authors of a large trial in India stated that "reputed elite institutions, first-world collaborations, third-party organizations, or big funding are a big help if available, but they are not indispensable." Grundy argued that framing the problem as needing to replace the large investment that industry has in clinical trials is insurmountable because of a lack of political will, "but I think it is also interesting to think about what research is actually needed, what is the priority, what resources are in place, and how can we leverage those most effectively." In addition to generating research results, the convalescent plasma trials also generated infrastructure and capacity within the countries that ran them.
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"I would argue that stewardship of resources and equity should be notions we further build into an idea of research integrity," she said. "We need to think of research, particularly health research, in the context of health systems and public health capacity and the role of public funding in relying on but also building and generating these public good." PROTECTING THE SCIENTIFIC INTEGRITY OF THE IARC MONOGRAPHS6 The International Agency for Research on Cancer (IARC)
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The invited specialist role also protects the integrity of scientists affiliated with interested parties, since they are present as a resource, not to influence the outcome, and therefore have no responsibility for an evaluation that might not end how their company wants. The process for selecting experts to participate on review committees starts with a literature search and public nominations to identify potential experts.
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IARC also has a process for independent reporting of COIs by a third party that he believes holds great promise for ensuring that organizations adopt a strong policy and do not backslide. At a monograph meeting, IARC asks experts to update their declarations and to complete The Lancet Oncology's COI form; the editor independently reviews the COI statements and reports any COIs alongside a published summary of the meeting (Cogliano et al., 2005)
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"We also need good review committees who are composed of knowledgeable experts who are free from conflicting interests and who can work free from interference," he said. "Not only must we reach an appropriate conclusion, but we must also do so in a transparent manner that promotes public confidence." MINIMIZING BIAS IN AHRQ EVIDENCE-BASED PRACTICE CENTER PROGRAM SYSTEMATIC REVIEWS9 Umscheid explained that the Agency for Healthcare Research and Quality (AHRQ)
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An AHRQ EPC systematic review is a summary of overall evidence to address a set of key questions identified, explained Umscheid. It is protocol driven and starts with a comprehensive search of existing peerreviewed studies.
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Umscheid explained that EPC used the Cochrane Risk of Bias 2 tool for randomized controlled trials and the Risk of Bias in NonRandomized Studies of Interventions tool. These tools assess the similarity between test and control groups at baseline, adherence of groups to assigned interventions, completeness of outcome assessments in each study group, and blinding of those prescribing and receiving interventions and those evaluating outcomes.
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FIGURE 5-3 Risk-of-bias table for randomized controlled trials on pharmacologic interventions for infantile epilepsy NOTE: SC = some concerns. SOURCE: Presented by Craig Umscheid on December 16, 2022 (Effective Health Care Program, 2022)
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Woodruff said that as NIH underwrites work that looks at the rigor of research, it should also fund areas to understand how its funding influences financial COIs. She noted the importance of access to the truth, which requires public access to industry documents.
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FIGURE 5-4 Strength-of-evidence table for trials on pharmacologic interventions for infantile epilepsy. SOURCE: Presented by Craig Umscheid on December 16, 2022 (Effective Health Care Program, 2022)
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Similarly, a study Lexchin participated in found that societies involved in sponsoring clinical practice guidelines in Canada were not disclosing their industry funding in the guidelines, though they did so on their websites (Elder et al., 2020)
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However, he noted that when McMaster University's general internal medicine residency program did so in the early 1990s, with agreement from the residents, the brand-name industry association threatened to withdraw research funding. Lexchin raised the issue of industry support for clinical trials of drugs and how that might affect pharmaceutical product approvals.
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"I think that is just a huge problem, and it makes it seem as if the FDA works with industry, not as a protector of public health." Sah said she agreed wholeheartedly with the suggestions that Woodruff and Lexchin made, and that public funding is a key aspect. She commented on industry threats to withdraw funding if new policies restrict access to research or clinicians and said this will be difficult to tackle without a big shift in how research is conducted, which needs a coordinated approach.
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She added that it is important to distinguish between the risk in individual studies and the types of bias seen across a body of studies, such as publication or funding bias. Gunsalus asked Sah to address an audience question about whether the pooled funding model leads to COIs at the institutional level and makes universities, rather than the individual investigators, beholden to their corporate sponsors.
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