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

Jaleh Fallah; Flora Mulkey; Mallorie H Fiero; Haley Gittleman; Chi Song; Jeevan Puthiamadathil; Anup Amatya; Sundeep Agrawal; Paz Vellanki; Daniel L Suzman; Harpreet Singh; Laleh Amiri-Kordestani; Pallavi Mishra-Kalyani; Richard Pazdur; Paul G Kluetz

doi:10.1200/JCO-24-01200

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

J Clin Oncol. 2024 Nov 10;42(32):3783-3787. doi: 10.1200/JCO-24-01200. Epub 2024 Sep 17.

Authors

Jaleh Fallah¹, Flora Mulkey¹, Mallorie H Fiero¹, Haley Gittleman¹, Chi Song¹, Jeevan Puthiamadathil¹, Anup Amatya¹, Sundeep Agrawal¹, Paz Vellanki¹, Daniel L Suzman¹, Harpreet Singh^{1

2}, Laleh Amiri-Kordestani^{1

2}, Pallavi Mishra-Kalyani¹, Richard Pazdur^{1

2}, Paul G Kluetz^{1

2}

Affiliations

¹ Center for Drug Evaluation and Research (CDER), US Food and Drug Administration, Silver Spring, MD.
² Oncology Center of Excellence (OCE), US Food and Drug Administration, Silver Spring, MD.

PMID: 39288354
DOI: 10.1200/JCO-24-01200

Abstract

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.

MeSH terms

Clinical Trials as Topic*
Humans
Neoplasms / drug therapy
Neoplasms / therapy
Research Design / standards
Therapeutic Equipoise*
United States
United States Food and Drug Administration