Aviso: Este sitio agrega datos públicos oficiales de la FDA, ClinicalTrials.gov, PubMed y SEC EDGAR solo como referencia general. No constituye asesoramiento médico, diagnóstico, recomendaciones de tratamiento ni asesoramiento de inversión.

PubMed

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

PMID: 34789308 ·

M, a, t, t, h, e, w, , J, , S, w, a, n, s, o, n, ;, , J, a, m, e, s, , L, , J, o, h, n, s, t, o, n, ;, , J, o, s, e, p, h, , S, , R, o, s, s

RevistaTrials
Año
PMID34789308

Resumen

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 is to compare registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk (class III) cardiovascular devices before and after the FDA Amendment Act (FDA

Fuente oficial

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Datos obtenidos de PubMed / NCBI. Para consultar el texto completo y la información más reciente, remítase siempre al registro oficial.

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