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Vaccine testing for emerging infections: the case for individual randomisation.
- Source :
- Journal of Medical Ethics; Sep2017, Vol. 43 Issue 9, p625-631, 7p
- Publication Year :
- 2017
-
Abstract
- During the 2014-2015 Ebola outbreak in Guinea, Liberia and Sierra Leone, many opposed the use of individually randomised controlled trials to test candidate Ebola vaccines. For a raging fatal disease, they explained, it is unethical to relegate some study participants to control arms. In Zika and future emerging infections, similar opposition may hinder urgent vaccine research, so it is best to address these questions now. This article lays out the ethical case for individually randomised control in testing vaccines against many emerging infections, including lethal infections in low-income countries, even when at no point in the trial do the controls receive the countermeasures being tested. When individual randomisation is feasible-and it often will be-it tends to save more lives than alternative designs would. And for emerging infections, individual randomisation also tends as such to improve care, access to the experimental vaccine and prospects for all participants relative to their opportunities absent the trial, and no less than alternative designs would. That obtains even under placebo control and without equipoise-requiring which would undermine individual randomisation and the alternative designs that opponents proffered. Our arguments expound four often-neglected factors: benefits to non-participants, benefits to participants once a trial is over including post-trial access to the study intervention, participants' prospects before randomisation to arms and the near-inevitable disparity between arms in any randomised controlled trial. [ABSTRACT FROM AUTHOR]
- Subjects :
- VACCINATION
INFECTION
INFECTION prevention
STANDARDIZATION
TECHNICAL specifications
CLINICAL trials & ethics
PREVENTION of communicable diseases
EBOLA virus disease prevention
MEDICAL research ethics
BENEVOLENCE
DEVELOPING countries
EPIDEMICS
EXPERIMENTAL design
RESEARCH funding
VACCINES
VIRAL vaccines
Subjects
Details
- Language :
- English
- ISSN :
- 03066800
- Volume :
- 43
- Issue :
- 9
- Database :
- Complementary Index
- Journal :
- Journal of Medical Ethics
- Publication Type :
- Academic Journal
- Accession number :
- 124880604
- Full Text :
- https://doi.org/10.1136/medethics-2015-103220