Literature DB >> 34908169

Allocation of Opportunities to Participate in Clinical Trials during the Covid-19 Pandemic and Other Public Health Emergencies.

Kayte Spector-Bagdady, Holly Fernandez Lynch, Barbara E Bierer, Luke Gelinas, Sara Chandros Hull, David Magnus, Michelle N Meyer, Richard R Sharp, Jeremy Sugarman, Benjamin S Wilfond, Ruqaiijah Yearby, Seema Mohapatra.   

Abstract

Covid-19 raised many novel ethical issues including regarding the allocation of opportunities to participate in clinical trials during a public health emergency. In this article, we explore how hospitals that have a scarcity of trial opportunities, either overall or in a specific trial, can equitably allocate those opportunities in the context of an urgent medical need with limited therapeutic interventions. We assess the three main approaches to allocating trial opportunities discussed in the literature: patient choice, physician referral, and randomization/lottery. As, we argue, none of the three typical approaches are ethically ideal for allocating trial opportunities in the pandemic context, many hospitals have instead implemented hybrid solutions. We offer practical guidance to support those continuing to face these challenges, and we analyze options for the future.
© 2022 The Hastings Center.

Entities:  

Keywords:  Covid-19; clinical trials; public health; research ethics; trial recruitment

Mesh:

Year:  2021        PMID: 34908169      PMCID: PMC9414770          DOI: 10.1002/hast.1297

Source DB:  PubMed          Journal:  Hastings Cent Rep        ISSN: 0093-0334            Impact factor:   4.298


  29 in total

1.  Case study. Is longer always better? Commentary.

Authors:  Ezekiel J Emanuel; Christine Grady
Journal:  Hastings Cent Rep       Date:  2008 May-Jun       Impact factor: 2.683

2.  Critical Race Theory, race equity, and public health: toward antiracism praxis.

Authors:  Chandra L Ford; Collins O Airhihenbuwa
Journal:  Am J Public Health       Date:  2010-02-10       Impact factor: 9.308

3.  Competing for patients: an ethical framework for recruiting patients with brain tumors into clinical trials.

Authors:  George M Ibrahim; Caroline Chung; Mark Bernstein
Journal:  J Neurooncol       Date:  2011-02-12       Impact factor: 4.130

4.  Four Faces of Fair Subject Selection.

Authors:  Douglas MacKay; Katherine Witte Saylor
Journal:  Am J Bioeth       Date:  2020-02       Impact factor: 11.229

5.  Addressing Health Disparities Among Minority Populations: Why Clinical Trial Recruitment Is Not Enough.

Authors:  Consuelo H Wilkins; Suzanne E Schindler; John C Morris
Journal:  JAMA Neurol       Date:  2020-09-01       Impact factor: 18.302

Review 6.  Are racial and ethnic minorities less willing to participate in health research?

Authors:  David Wendler; Raynard Kington; Jennifer Madans; Gretchen Van Wye; Heidi Christ-Schmidt; Laura A Pratt; Otis W Brawley; Cary P Gross; Ezekiel Emanuel
Journal:  PLoS Med       Date:  2005-12-06       Impact factor: 11.069

7.  Advantages of Using Lotteries to Select Participants for High-Demand Covid-19 Treatment Trials.

Authors:  Alexander A Iyer; Saskia Hendriks; Annette Rid
Journal:  Ethics Hum Res       Date:  2020-06-22

8.  Dexamethasone in Hospitalized Patients with Covid-19.

Authors:  Peter Horby; Wei Shen Lim; Jonathan R Emberson; Marion Mafham; Jennifer L Bell; Louise Linsell; Natalie Staplin; Christopher Brightling; Andrew Ustianowski; Einas Elmahi; Benjamin Prudon; Christopher Green; Timothy Felton; David Chadwick; Kanchan Rege; Christopher Fegan; Lucy C Chappell; Saul N Faust; Thomas Jaki; Katie Jeffery; Alan Montgomery; Kathryn Rowan; Edmund Juszczak; J Kenneth Baillie; Richard Haynes; Martin J Landray
Journal:  N Engl J Med       Date:  2020-07-17       Impact factor: 91.245

Review 9.  Ensuring that COVID-19 research is inclusive: guidance from the NIHR INCLUDE project.

Authors:  Miles D Witham; Eleanor Anderson; Camille B Carroll; Paul M Dark; Kim Down; Alistair S Hall; Joanna Knee; Eamonn R Maher; Rebecca H Maier; Gail A Mountain; Gary Nestor; John T O'Brien; Laurie Oliva; James Wason; Lynn Rochester
Journal:  BMJ Open       Date:  2020-11-05       Impact factor: 2.692

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