Sponsor Influences on the Quality and Independence of Health Research Proceedings of a Workshop (2023) / Chapter Skim
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4 Protection of Research Integrity
4 Protection of Research Integrity
Pages 39-52
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From page 39... ...
, discussed how to gain sponsor support while maintaining independence. Clive Green, executive director of biopharmaceuticals research and development at AstraZeneca, addressed the application of corporate ethical policies and governance processes with an emphasis on bioethics.
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She began by talking about rigor and transparency in grant applications; NIH defines rigor as "the strict application of the scientific method to ensure unbiased and well-controlled experimental design, methodology, analysis, interpretation, and reporting of results." In 2016, NIH implemented a policy called "enhancing reproducibility through rigor and transparency" to respond to concerns about the lack of reproducibility of preclinical data in publications.2 It required grant applicants to describe their research in more detail and how they planned to produce rigorous research. The policy also allowed grant reviewers to judge applications based on the rigor of prior research and plans to address weaknesses in it; the rigor of the proposed research; the role of relevant biological variables, such as sex, on the proposed research; and authentication of key biological or chemical resources (see Figure 4-1)
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From page 41... ...
FIGURE 4-1 NIH infographic illustrating the key features of the new requirements for grant applicants based on the enhancing 41 reproducibility through rigor and transparency policy. SOURCE: Presented by Patricia Valdez on December 14, 2022 (Swan et al., 2019)
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From page 42... ...
In terms of the integrity of the peer-review process, NIH staff receives training on how to handle allegations of research misconduct, said Valdez. Before each meeting, NIH instructs reviewers and council members to report an allegation to the designated federal officer, who then reports it to the assigned research integrity officer in the relevant institute or center.
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GAINING SPONSOR SUPPORT WHILE MAINTAINING SCIENTIFIC INDEPENDENCE4 HEI, said Daniel Greenbaum, was launched in 1980 after the Environmental Protection Agency (EPA) administrator and motor vehicle 3 Additional information is available at https://grants.nih.gov/policy/clinical-trials/ reporting/index.htm (accessed February 3, 2023)
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The strategic plan informs a detailed process that Greenbaum said is similar in some ways to the NIH process Valdez described, involving soliciting grant applications, conducting a two-stage review, and overseeing the resulting research. Scientists populate the research committee, and HEI requires them to file COI disclosures and that no members of
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For example, in the late 1990s, EPA was considering a new standard for fine particulate air pollution based on the Harvard Six Cities Study results and an American Cancer Society study. EPA, industry, and Congress called for a reanalysis of the data, and the investigators from the two studies provided full access to their data.
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Bioethics at AstraZeneca is governed under the company's global bioethics policy that covers a range of subjects, including clinical research integrity. Green noted that as a pharmaceutical company, AstraZeneca funds and conducts scientific research, and this policy covers sponsor influence in research that spans clinical and drug discovery activities.
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The company also has an internal bioethics advisory group that advises on implanting global standards, comprises individuals from a wide range of topics, and is supported by leaders from the company's legal, compliance, and corporate affairs departments. It exists to provide advice, support, and guidance to scientists, project teams, and company leaders on bioethical issues, and it engages in horizon scanning to see where scientific, technical, and societal developments will prompt ethical challenges, said Green.
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From page 48... ...
"If we do not have methods and approaches to identify COIs and industry sponsorship within those primary studies, and we do not attempt to quantify that level of influence, we may have an evidence base that can be skewed in favor of an industry's product if that is the focus of the evaluation of the evidence," said Chartres, adding that identifying and quantifying COIs in primary studies does not mean removing them from systematic reviews or meta-research but rather considering them in assessing a body of evidence. Ruskin said that U.S.
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Greenbaum noted that one group missing from the day's discussions is the scientific journal editorial community, given that most journals do not want to publish negative results, even for well-executed studies. Green agreed about that dearth of negative results, which will hinder future developments, such as powering AI models.
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In terms of safeguards, Chartres believes that the scientific and research community needs to better understand that industry influence is happening, which is why he thinks this workshop is critical to informing the public and researchers about the extent of that bias and how it affects it public health and health care decisions. Journals requiring COI statements are a step in the right direction, said Chartres, citing the Cochrane model regarding disclosure as one that most journals could use.
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Ruskin commented that the current situation is courting a crisis of confidence in the nation's health institutions, given how heavily rooted they are in an evidence base that "may well not be trustworthy because so much of it may well be tainted by corporate influence." Some estimates, he said, attribute nearly 60 percent of medical research funding to industry, and much of that research will be biased toward product defense and overstating product benefit. "Without a clean and uncorrupted evidence base, many people are just not going to trust or listen to scientific studies, public health leaders, medical institutions, regulatory agencies, and other health bodies," said Ruskin.
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From page 52... ...
"We have to tell the truth to the American people, that our current health evidence base may well not be that reliable and that as a matter of federal and state policy, we are going to do better and build a health evidence base that people can trust and believe in," said Ruskin. "We cannot allow corporate [public relations]
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