Navigating the expanded access investigational new drug protocol for tecovirimat: lessons learned from a public-private hospital partnership during the 2022 NYC mpox outbreak.

Ofole MgbakoJustin ChanRobert A PittsMadeline A DiLorenzoDorothy KnutsenDana Mazo

Published in: Antimicrobial stewardship & healthcare epidemiology : ASHE (2023)

During the 2022 mpox outbreak, tecovirimat was accessed through an expanded access investigational new drug (EA-IND) protocol. We leveraged a unique public/private hospital partnership in New York City to create a novel infrastructure to navigate the EA-IND's regulatory requirements and rapidly provide tecovirimat to patients.

Keyphrases

healthcare
adverse drug
end stage renal disease
randomized controlled trial
ejection fraction
health insurance
newly diagnosed
mental health
chronic kidney disease
peritoneal dialysis
transcription factor
phase ii
emergency department
patient reported outcomes
clinical trial
electronic health record
double blind