Application of estimand framework in ICH E9 (R1) to vaccine trials.

Fu, Rong; Li, Hal; Wang, Xuelong; Shou, Qiong; Wang, William W B

Fu, Rong; Li, Hal; Wang, Xuelong; Shou, Qiong; Wang, William W B.

Afiliación

Fu R; BARDS, MSD, Beijing, USA.
Li H; BARDS, Merck & Co. Inc, Rahway, New Jersey, USA.
Wang X; BARDS, Merck & Co. Inc, Rahway, New Jersey, USA.
Shou Q; BARDS, MSD, Beijing, USA.
Wang WWB; BARDS, Merck & Co. Inc, Rahway, New Jersey, USA.

J Biopharm Stat ; 33(4): 502-513, 2023 Jul 04.

Article en En | MEDLINE | ID: mdl-37012654

RESUMEN

Over the past decades, the primary interest in vaccine efficacy or immunogenicity evaluation mostly focuses on the biological effect of immunization in complying with the vaccination schedule in a targeted population. The safety questions, which are essential for vaccines as they are generally given to large healthy populations, need to be clearly defined to reflect the risk assessment of interest. ICH E9 (R1) provides a structured framework to clarify the clinical questions and formulate the treatment effect as an estimand. This paper applies the estimand framework to vaccine clinical trials on common clinical questions regarding efficacy, immunogenicity, and safety.

Asunto(s)

Vacunas; Humanos; Interpretación Estadística de Datos; Vacunas/uso terapéutico; Vacunación; Proyectos de Investigación

Palabras clave

Vaccine trials; efficacy; estimand framework; immunogenicity; intercurrent events; safety

Texto completo

Añadir a Mi BVS

Imprimir

XML

PubMed Links

Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Vacunas Tipo de estudio: Risk_factors_studies Límite: Humans Idioma: En Revista: J Biopharm Stat Asunto de la revista: FARMACOLOGIA Año: 2023 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido

Texto completo

Añadir a Mi BVS

Imprimir

XML

PubMed Links

Buscar en Google