PubMed

Effect of the FDA Safety and Innovation Act on racial and gender diversity in neurosurgical device trials.

PMID: 34171831 · 2021-06-25

N, e, h, a, , S, i, d, d, i, q, u, i, ;, , R, y, a, n, , G, , C, h, i, u, ;, , R, a, v, i, , S, , N, u, n, n, a, ;, , G, e, o, r, g, i, a, , G, l, a, s, t, r, i, s, ;, , A, n, k, i, t, , I, , M, e, h, t, a

ЖурналJournal of neurosurgery

Год2021-06-25

PMID34171831

Аннотация

The US FDA uses evidence from clinical trials in its determination of safety and utility. However, these trials have often suffered from limited external validity and generalizability due to unrepresentative study populations with respect to clinical patient demographics. Section 907 of the FDA Safety and Innovation Act (FDASIA) of 2012 attempted to address this issue by mandating the reporting of certain study demographics in new device applications. However, no study has been performed on its

Официальный источник

Открыть в PubMed →

Данные получены из PubMed / NCBI. Полный текст и наиболее актуальную информацию всегда смотрите в официальной записи.