JAMA
Original Investigation
April 22, 2024
Joshua D.ÌýWallach,ÌýPhD, MS; SamuelÌýYoon,ÌýBS, BA; HarryÌýDoernberg,ÌýMM; Laura R.ÌýGlick,ÌýMD; OrianaÌýCiani,ÌýPhD; Rod S.ÌýTaylor,ÌýPhD; MaryamÌýMooghali,ÌýMD; ReshmaÌýRamachandran,ÌýMD, MHS, MPP; Joseph S.ÌýRoss,ÌýMD, MHS
online first
JAMA. 2024; 10.1001/jama.2024.4175
This study examines the strength of association between surrogate markers used as primary end points in clinical trials to support FDA approval of drugs treating nononcologic chronic diseases and clinical outcomes.
ÁñÁ«ÊÓƵ Network Open
Research Letter
Health Policy
January 19, 2023
OrianaÌýCiani,ÌýPhD; MichelaÌýMeregaglia,ÌýPhD; FrancescoÌýDe Lorenzo,ÌýMD; FrancescoÌýPerrone,ÌýMD; CarmineÌýPinto,ÌýMD
open access
ÁñÁ«ÊÓƵ Netw Open. 2023; 6(1):e2251564. 10.1001/jamanetworkopen.2022.51564
This cross-sectional study investigates the use of patient-reported outcome measures in new marketing authorizations for oncology drugs approved by the European Medicines Agency (EMA) between 2017 and 2021.
JAMA Internal Medicine
Comment & Response
January 31, 2022
KevinÌýO’Fee,ÌýMD; OrianaÌýCiani,ÌýPhD; David L.ÌýBrown,ÌýMD
JAMA Intern Med. 2022; 182(3):357-358. 10.1001/jamainternmed.2021.8132
JAMA Internal Medicine
Original Investigation
October 25, 2021
KevinÌýO’Fee,ÌýMD; ElenaÌýDeych,ÌýMS; OrianaÌýCiani,ÌýPhD; David L.ÌýBrown,ÌýMD
free access
JAMA Intern Med. 2021; 181(12):1575-1587. 10.1001/jamainternmed.2021.5726
This meta-analysis of randomized clinical trials examines the use of myocardial infarction as a surrogate for all-cause or cardiovascular mortality in patients with or at risk for cardiovascular disease.