Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA

BACKGROUND: Selective registration, publication, and outcome reporting of clinical trials distort the primary clinical evidence that is available to patients and clinicians regarding the safety and efficacy of US Food and Drug Administration (FDA)-approved medical devices. The purpose of this study...

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Detalles Bibliográficos
Autores principales: Swanson, Matthew J., Johnston, James L., Ross, Joseph S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8597303/
https://www.ncbi.nlm.nih.gov/pubmed/34789308
http://dx.doi.org/10.1186/s13063-021-05790-9

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8597303/
https://www.ncbi.nlm.nih.gov/pubmed/34789308
http://dx.doi.org/10.1186/s13063-021-05790-9

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