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Reconsidering scarce drug rationing: implications for clinical research
  1. Zev M Nakamura1,2,
  2. Douglas P MacKay3,4,
  3. Arlene M Davis4,5,
  4. Elizabeth R Brassfield6,7,
  5. Benny L Joyner Jr.5,8,9,
  6. Donald L Rosenstein1,2,10
  1. 1Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
  2. 2Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
  3. 3Public Policy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
  4. 4Center of Bioethics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
  5. 5Social Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
  6. 6Philosophy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
  7. 7University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA
  8. 8Pediatrics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
  9. 9Anesthesiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
  10. 10Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
  1. Correspondence to Dr Zev M Nakamura, Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; zev_nakamura{at}med.unc.edu

Abstract

Hospital systems commonly face the challenge of determining just ways to allocate scarce drugs during national shortages. There is no standardised approach of how this should be instituted, but principles of distributive justice are commonly used so that patients who are most likely to benefit from the drug receive it. As a result, clinical indications, in which the evidence for the drug is assumed to be established, are often prioritised over research use. In this manuscript, we present a case of a phase II investigational trial of intravenous thiamine for delirium prevention in patients undergoing haematopoietic stem cell transplantation to emphasise several shortcomings in the overarching prioritisation of clinical over research uses of scarce drugs. Specifically, we present the following considerations: (1) clinical use may not have stronger evidence than research use; (2) a strong scientific rationale for research use may outweigh the claim for clinical indications in which there is weak evidence; (3) treatment within the context of a clinical trial may be the standard of care; and (4) research use may not only benefit patients receiving the treatment but also offers the prospect of improving future clinical care. In summary, we argue against allocation schemes that prohibit all research uses of scarce drugs and instead recommend that allocation schemes include a balanced approach that weighs risks and benefits of access to scarce drugs irrespective of the research versus clinical use designation.

  • clinical trials
  • distributive Justice
  • ethics
  • ethics committees/consultation
  • research ethics
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Footnotes

  • Contributors All authors contributed to the preparation of the manuscript and have agreed to the final draft. ZMN, DMK and DLR led the initial drafting and formulation of the arguments. ZMN completed the final draft. DMK, AD, ERB, BLJ and DLR contributed to revising the draft.

  • Funding This work was supported by the Rising Tide Foundation for Clinical Cancer Research (Grant Number CCR-17-300, co-principal investigators ZMN and DLR).

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval The study referenced in the case presentation was approved by the University of North Carolina Institutional Review Board. This manuscript does not contain personal and/or medical information about identifiable living individuals.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement All data relevant to the study are included in the article.

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