Considerations for unblinding individual study participants during vaccine trials.
Vaccine
; 41(22): 3399-3402, 2023 05 22.
Article
em En
| MEDLINE
| ID: mdl-37121805
ABSTRACT
Premature unblinding of individual participants is rarely reported in publications, but such unblinding can disrupt vaccine trials by causing worry and drop-out of other participants or "pseudo unblinding," in which participants or investigators over-interpret certain symptoms as being related to receiving an investigational product. This review summarizes appropriate reasons for unblinding in vaccine trials. Regulatory guidance could be improved by distinguishing guidance for vaccine trials from drug trials, with the recognition that unblinding individual participants in vaccine studies is rarely needed for management of adverse events following immunization.
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Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Vacinas
/
Vacinação
Idioma:
En
Ano de publicação:
2023
Tipo de documento:
Article