Haftungsausschluss: Diese Website bündelt öffentlich verfügbare Daten aus offiziellen Quellen wie FDA, ClinicalTrials.gov, PubMed und SEC EDGAR nur zur allgemeinen Information. Sie stellt keine medizinische Beratung, Diagnose, Behandlungsempfehlung oder Anlageberatung dar.

PubMed

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

PMID: 34171831 ·

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

ZeitschriftJournal of neurosurgery
Jahr
PMID34171831

Zusammenfassung

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

Offizielle Quelle

Auf PubMed ansehen →

Daten aus PubMed / NCBI. Den Volltext und die aktuellsten Informationen finden Sie stets im offiziellen Eintrag.

↑