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Related Experiment Videos

Vaccine testing for emerging infections: the case for individual randomisation.

Nir Eyal1, Marc Lipsitch2

  • 1Department of Global Health and Population, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, USA.

Journal of Medical Ethics
|April 12, 2017
PubMed
Summary

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Individually randomised controlled trials are ethical for testing vaccines against emerging infectious diseases, even lethal ones. This method saves more lives and improves participant care compared to alternative trial designs.

Area of Science:

  • Medical ethics
  • Infectious disease research
  • Vaccinology

Background:

  • Ethical objections arose against individually randomised controlled trials (RCTs) during the 2014-2015 Ebola outbreak.
  • Concerns about assigning participants to control arms for fatal diseases may impede future vaccine research for emerging infections like Zika.

Purpose of the Study:

  • To present the ethical justification for using individually RCTs in vaccine trials for emerging infections.
  • To address ethical concerns regarding control groups in vaccine trials for lethal diseases, particularly in low-income countries.

Main Methods:

  • Ethical analysis of individually randomised controlled trials versus alternative trial designs.
  • Consideration of factors including benefits to non-participants, post-trial access to interventions, and pre-trial participant prospects.
Keywords:
Allocation of Health Care ResourcesClinical trialsEpidemiologyEthicsResearch Ethics

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Main Results:

  • Individually RCTs, when feasible, tend to save more lives than alternative designs.
  • Individual randomisation can improve overall participant care and access to experimental vaccines, even under placebo control.

Conclusions:

  • Individually RCTs are ethically justifiable for testing vaccines against emerging and lethal infectious diseases.
  • This trial design offers significant benefits to participants and non-participants, enhancing public health outcomes.