Literature DB >> 28108613

When clinical trials compete: prioritising study recruitment.

Luke Gelinas1, Holly Fernandez Lynch2, Barbara E Bierer3, I Glenn Cohen1.   

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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Entities:  

Keywords:  Clinical trials; Ethics; Philosophical Ethics; Research Ethics; Resource Allocation

Mesh:

Year:  2017        PMID: 28108613      PMCID: PMC5519451          DOI: 10.1136/medethics-2016-103680

Source DB:  PubMed          Journal:  J Med Ethics        ISSN: 0306-6800            Impact factor:   2.903


  14 in total

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5.  False hopes and best data: consent to research and the therapeutic misconception.

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6.  Coping with an embarrassment of riches. How stroke centers may participate in multiple, concurrent clinical stroke trials.

Authors:  J L Saver
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Authors:  George M Ibrahim; Caroline Chung; Mark Bernstein
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8.  The continuing unethical conduct of underpowered clinical trials.

Authors:  Scott D Halpern; Jason H T Karlawish; Jesse A Berlin
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9.  How to increase value and reduce waste when research priorities are set.

Authors:  Iain Chalmers; Michael B Bracken; Ben Djulbegovic; Silvio Garattini; Jonathan Grant; A Metin Gülmezoglu; David W Howells; John P A Ioannidis; Sandy Oliver
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Authors:  John P A Ioannidis; Sander Greenland; Mark A Hlatky; Muin J Khoury; Malcolm R Macleod; David Moher; Kenneth F Schulz; Robert Tibshirani
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Authors:  John H Rex; Holly Fernandez Lynch; I Glenn Cohen; Jonathan J Darrow; Kevin Outterson
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4.  Ethical Challenges in Clinical Research During the COVID-19 Pandemic.

Authors:  B E Bierer; S A White; J M Barnes; L Gelinas
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Journal:  Transl Vis Sci Technol       Date:  2020-06-03       Impact factor: 3.283

7.  Research response to coronavirus disease 2019 needed better coordination and collaboration: a living mapping of registered trials.

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9.  Regional variations in adverse event reporting rates and ACR responses in placebo/standard-of-care arms of rheumatoid arthritis trials.

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10.  How informative were early SARS-CoV-2 treatment and prevention trials? a longitudinal cohort analysis of trials registered on ClinicalTrials.gov.

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