Use, Safety, and Efficacy of Single-Patient Use of the US Food and Drug Administration Expanded Access Program

JAMA Oncol. 2019 Apr 1;5(4):570-572. doi: 10.1001/jamaoncol.2018.7002.

Noah Z Feit¹, Debra A Goldman², Evan Smith³, Jenny Deighan⁴, Alexia Iasonos^{1

2}, Oliver Zivanovic³, David M Hyman^{1

5}

¹ Weill Cornell Medical College, New York, New York.
² Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.
³ Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.
⁴ Human Research Protection Program, Memorial Sloan Kettering Center, New York, New York.
⁵ Early Drug Development Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.

Abstract

This study assesses the outcomes of single-patient use of the US Food and Drug Administration Expanded Access program.