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When clinical trials compete: prioritising study recruitment
  1. Luke Gelinas1,
  2. Holly Fernandez Lynch2,
  3. Barbara E Bierer3,
  4. I Glenn Cohen1
  1. 1Petrie-Flom Center at Harvard Law School and Harvard Catalyst, Cambridge, Massachusetts, USA
  2. 2Petrie-Flom Center at Harvard Law School, Harvard Catalyst, and Center for Bioethics, Harvard Medical School, Cambridge, Massachusetts, USA
  3. 3Brigham and Women's Hospital, Harvard Medical School, and Harvard Catalyst, Boston, Massachusetts, USA
  1. Correspondence to Dr. Luke Gelinas Petrie-Flom Center Harvard Law School, 23 Everett Street, Cambridge, MA 02138

Abstract

It is not uncommon for multiple clinical trials at the same institution to recruit concurrently from the same patient population. When the relevant pool of patients is limited, as it often is, trials essentially compete for participants. There is evidence that such a competition is a predictor of low study accrual, with increased competition tied to increased recruitment shortfalls. But there is no consensus on what steps, if any, institutions should take to approach this issue. In this article, we argue that an institutional policy that prioritises some trials for recruitment ahead of others is ethically permissible and indeed prima facie preferable to alternative means of addressing recruitment competition. We motivate this view by appeal to the ethical importance of minimising the number of studies that begin but do not complete, thereby exposing their participants to unnecessary risks and burdens in the process. We then argue that a policy of prioritisation can be fair to relevant stakeholders, including participants, investigators and funders. Finally, by way of encouraging and helping to frame future debate, we propose some questions that would need to be addressed when identifying substantive ethical criteria for prioritising between studies.

  • Clinical trials
  • Research Ethics
  • Resource Allocation
  • Ethics
  • Philosophical Ethics
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Footnotes

  • Contributors All four authors meet the criteria set out in ICMJE Recommendations 2013. IGC oversaw the project, LG took the lead and spent the most in terms of time, energy, ideas, suggestions for revisions and so on, with HFL and BEB second and third on that count.

  • Funding National Center for Research Resources and the National Center for Advancing Translational Sciences, NIH (Award UL1 TR001102).

  • Competing interests None declared.

  • Provenance and peer review Commissioned; externally peer reviewed.

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