The continued use of placebo arms in COVID-19 vaccine trials does not adequately protect the well-being of participants.
Indian J Med Ethics
; VI(2): 1-10, 2021.
Artículo
en Inglés
| MEDLINE | ID: covidwho-1206590
ABSTRACT
Covid-19 vaccines are a critical tool for controlling the pandemic. While safe and effective vaccines have been developed, research is expected to continue for many years regarding the optimal implementation of existing vaccines in specific settings, and the development of second-generation vaccines that may offer advantages in terms of either efficacy or ease of implementation. Given this context, some commentators have argued that new Covid vaccine trials should be able to use placebo controls, and that existing studies should be able to continue with blinded participants in order to collect high quality, unbiased data. Using international ethics guidance documents, this paper argues against placebo controls, given the existence of proven effective interventions, and against protracted blinding once safety and efficacy milestones have been met. Instead, it advocates for study designs that allow for direct comparison between approved and experimental vaccines, which facilitates both data collection and greater access to vaccines.
Texto completo:
Disponible
Colección:
Bases de datos internacionales
Base de datos:
MEDLINE
Asunto principal:
Placebos
/
Guías como Asunto
/
Investigación Biomédica
/
Seguridad del Paciente
/
Vacunas contra la COVID-19
/
COVID-19
/
Derechos Humanos
Tipo de estudio:
Ensayo controlado aleatorizado
Tópicos:
Vacunas
Límite:
Humanos
Idioma:
Inglés
Revista:
Indian J Med Ethics
Asunto de la revista:
Etica
Año:
2021
Tipo del documento:
Artículo
País de afiliación:
IJME.2021.020
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