Equipoise Lost? Trial Conduct Challenges in an Era of Breakthrough Therapies.

Autor: Fallah J; Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD., Mulkey F; Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD., Fiero MH; Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD., Gittleman H; Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD., Song C; Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD., Puthiamadathil J; Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD., Amatya A; Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD., Agrawal S; Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD., Vellanki P; Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD., Suzman DL; Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD., Singh H; Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.; Oncology Center of Excellence (OCE), US Food and Drug Administration, Silver Spring, MD., Amiri-Kordestani L; Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.; Oncology Center of Excellence (OCE), US Food and Drug Administration, Silver Spring, MD., Mishra-Kalyani P; Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD., Pazdur R; Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.; Oncology Center of Excellence (OCE), US Food and Drug Administration, Silver Spring, MD., Kluetz PG; Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.; Oncology Center of Excellence (OCE), US Food and Drug Administration, Silver Spring, MD.
Jazyk: angličtina
Zdroj: Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2024 Nov 10; Vol. 42 (32), pp. 3783-3787. Date of Electronic Publication: 2024 Sep 17.
DOI: 10.1200/JCO-24-01200
Abstrakt: FDA Oncology Center's @Falleh_Fallah and colleagues discuss loss of equipoise and other trial conduct challenges in an era of breakthrough therapies - via @JCO_ASCO.
Databáze: MEDLINE