Advertisement

Pledging to Address Scientific Bias in Published Literature

      Addressing health care bias has become an important and necessary priority. Implicit bias resulting in inequities in diversity and inclusion to both access to care and provision of care is beginning to garner the attention it has long deserved.
      • Chapman EN
      • Kaatz A
      • Carnes M.
      Physicians and implicit bias: how doctors may unwittingly perpetuate health care disparities.
      • Gopal DP
      • Chetty U
      • O'Donnell P
      • et al.
      Implicit bias in healthcare: clinical practice, research and decision making.
      • FitzGerald C
      • Hurst S.
      Implicit bias in healthcare professionals: a systematic review.
      However, an additional bias is concomitantly occurring in health care, namely, scientific bias.
      • Jureidini J
      • McHenry L.
      The Illusion of Evidence-Based Medicine: Exposing the Crisis of Credibility in Clinical Research.
      The influence of pharmaceutical companies on data reporting, combined with the often seemingly complacency of scientific journals to publish negative studies, have blurred the boundaries between fact and a biased interpretation of the facts.In this issue of Clinical Therapeutics, Morrow and colleagues
      • Morrow RL
      • Mintzes B
      • Gray G
      • et al.
      Industry sponsor influence in clinical trial reporting in Canada: a qualitative interview study.
      highlight implicit and explicit challenges in the Canadian system regarding the pharmaceutical influence on trial data result reporting. In response, Drs Zarin and Selker
      • Zarin DA
      • Selker HP.
      Reporting of clinical trial results: aligning incentives and requirements to do the right thing.
      outline a series of successful strategies utilized in the United States and other nations to ensure transparent scientific reporting, including participation in international trial registries
      and full disclosure of incentive structures. This transparency is essential for objective interpretation of the data that ultimately will inform care. Failure to incorporate such transparent strategies results in missed opportunities to guide future studies void of redundancy in trial design and subsequent duplication of negative results. These calls to action are not an adjudication on Pharmaceutical-sponsored trials. The health care system depends on the support of Pharma to rapidly develop, test, and assess newly emerging therapies. Funds flowing from both governmental funding agencies (ie, the National Institute of Health) as well as Pharmaceutical companies are required to expeditiously and safely progress from Phase I to Phase III trials. As the world witnessed during the ongoing COVID-19 pandemic, it took the monetary backing of Pfizer, Moderna, and Johnson & Johnson to bring novel vaccines through to US Food and Drug Administration emergency use approval in mere months’ time.
      • Walsh EE
      • Frenck Jr, RW
      • Falsey AR
      • et al.
      Safety and immunogenicity of two RNA-based Covid-19 vaccine candidates.
      ,
      • Sadoff J
      • Le Gars M
      • Shukarev G
      • et al.
      Interim results of a Phase 1-2a trial of Ad26.COV2.S Covid-19 vaccine.
      Rather, highlighting potential bias in data reporting, which can easily be driven in part by Pharma's influence, must be mitigated with clear, objective, universal paths forward. We must strive toward responsible partnerships with Pharma to ensure that patient trust is coveted, and patient care, treatments, and outcomes are optimized.
      Although the role of Pharmaceutical's influence over data reporting needs oversight, the precedent on how to limit scientific bias in health care has been set. The Physician Payments Sunshine Act of the Patient Protection and Affordable Care Act mandates that medical or pharmaceutical product manufacturers disclose any payments or transfers made to individual physicians or teaching hospitals. Disclosed relationships are publicly available and updated yearly so that any bias, perceived or otherwise, is properly and promptly reported. The apparent disconnect between regulatory processes imposed at an individual or institutional level, as compared to influence by Pharma itself, must be acknowledged and rectified with transparent rules that are bidirectional and apply to all.
      As a journal devoted to the publication of emerging therapeutics and diagnostics, Clinical Therapeutics has a unique responsibility to ensure that bias in scientific reporting is mitigated or, ideally, eliminated altogether. Recently, we have reaffirmed our commitment to ensure diversity and inclusion across our Editorial Board so that implicit bias in health care is minimized, and our board is representative of both the authors and study participants who inform our science.
      • Jhaveri R
      • Maron J.
      Our pledge to assemble a more diverse and inclusive editorial team at Clinical Therapeutics.
      We want to take this opportunity to pledge an equal commitment to address scientific bias in our publications. We encourage the submission of negative studies from well-designed clinical trials and will continue to report all monetary support from Pharma with a clear delineation of their role in study design, interpretation of data, and manuscript preparation. All published clinical trials are currently, and will remain, mandated to be reported in national or international registries for consideration of review. We believe these affirmations are essential to the integrity of science and clinical care and encourage our colleagues to join us in pledging to reduce scientific bias.

      References

        • Chapman EN
        • Kaatz A
        • Carnes M.
        Physicians and implicit bias: how doctors may unwittingly perpetuate health care disparities.
        J Gen Intern Med. 2013; 28: 1504-1510
        • Gopal DP
        • Chetty U
        • O'Donnell P
        • et al.
        Implicit bias in healthcare: clinical practice, research and decision making.
        Future Healthc J. 2021; 8: 40-48
        • FitzGerald C
        • Hurst S.
        Implicit bias in healthcare professionals: a systematic review.
        BMC Med Ethics. 2017; 18: 19
        • Jureidini J
        • McHenry L.
        The Illusion of Evidence-Based Medicine: Exposing the Crisis of Credibility in Clinical Research.
        Publisher: Wakefield Press, Cambridge, MAJuly, 2020
        • Morrow RL
        • Mintzes B
        • Gray G
        • et al.
        Industry sponsor influence in clinical trial reporting in Canada: a qualitative interview study.
        Clin Ther. 2022; 44: 374-388
        • Zarin DA
        • Selker HP.
        Reporting of clinical trial results: aligning incentives and requirements to do the right thing.
        Clin Ther. 2022; 44: 439-441
        • Walsh EE
        • Frenck Jr, RW
        • Falsey AR
        • et al.
        Safety and immunogenicity of two RNA-based Covid-19 vaccine candidates.
        N Engl J Med. 2020; 383: 2439-2450
        • Sadoff J
        • Le Gars M
        • Shukarev G
        • et al.
        Interim results of a Phase 1-2a trial of Ad26.COV2.S Covid-19 vaccine.
        N Engl J Med. 2021; 384: 1824-1835
      1. https://www.healthcarecompliancepros.com/blog/the-sunshine-act-an-overview. Accessed 15 February 2022.

        • Jhaveri R
        • Maron J.
        Our pledge to assemble a more diverse and inclusive editorial team at Clinical Therapeutics.
        Clin Ther. 2021; 44: 1-2