Real World-Evidence for Regulatory Use Decision Aid: An Interactive Tool To Inform Clinical Development and Regulatory Strategies

Real-world evidence (RWE) is increasingly used to complement clinical trial data for regulatory decision-making and in certain cases utilized to establish the clinical effectiveness of a therapy. However, the use of RWE is not applicable for all regulatory submissions, and it can be challenging to i...

Descripción completa

Detalles Bibliográficos
Autores principales: Burns, Leah, Kalesnik-Orszulak, Robert, Spring, Rick, Zeegers, Fabienne, Rutstein, Mark, Hukkelhoven, Mathias, Wruck, Lisa, O’Donnell, John
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2022
Materias:
Original Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9379219/
https://www.ncbi.nlm.nih.gov/pubmed/35972721
http://dx.doi.org/10.1007/s12325-022-02257-4

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9379219/
https://www.ncbi.nlm.nih.gov/pubmed/35972721
http://dx.doi.org/10.1007/s12325-022-02257-4

Ejemplares similares