Patient-Reported Outcomes in Clinical Trials Leading to Cancer Immunotherapy Drug Approvals From 2011 to 2018: A Systematic Review.

Houssein SafaMonica TamilPhilippe E SpiessBrandon ManleyJulio M Pow-SangScott M GilbertFiras SafaBrian D Gonzalez Laura B OswaldAdele SemaanAdi DiabJad Chahoud

Published in: Journal of the National Cancer Institute (2022)

Suboptimal reporting of PROs occurs regularly in cancer immunotherapy trials. Increased efforts are needed to maximize the value of these data in cancer immunotherapy development and approval.

Keyphrases

patient reported outcomes
clinical trial
adverse drug
electronic health record
big data
quality improvement
randomized controlled trial
emergency department
open label
deep learning
phase iii
double blind