Cargando…
Comparison of Duration of Postapproval vs Pivotal Trials for Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval, 2009-2018
This cross-sectional study compares the duration of postapproval trials with that of the pivotal trials used as the basis for the US Food and Drug Administration’s (FDA’s) approval for all indications receiving accelerated approval from 2009-2018.
Autores principales: | Wallach, Joshua D., Ramachandran, Reshma, Bruckner, Till, Ross, Joseph S. |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
American Medical Association
2021
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8579231/ https://www.ncbi.nlm.nih.gov/pubmed/34751764 http://dx.doi.org/10.1001/jamanetworkopen.2021.33601 |
Ejemplares similares
-
Characteristics of Preapproval and Postapproval Studies of Vaccines Granted Accelerated Approval by the US Food and Drug Administration
por: Egilman, Alexander, et al.
Publicado: (2021) -
Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval
por: Wallach, Joshua D., et al.
Publicado: (2021) -
Analysis of Postapproval Clinical Trials of Therapeutics Approved by the US Food and Drug Administration Without Clinical Postmarketing Requirements or Commitments
por: Skydel, Joshua J., et al.
Publicado: (2019) -
Spending by the Centers for Medicare & Medicaid Services Before and After Confirmation of Benefit for Drugs Granted US Food and Drug Administration Accelerated Approval, 2012 to 2017
por: Skydel, Joshua J., et al.
Publicado: (2022) -
Comparison of treatment effect sizes from pivotal and postapproval trials of novel therapeutics approved by the FDA based on surrogate markers of disease: a meta-epidemiological study
por: Wallach, Joshua D., et al.
Publicado: (2018)