Evaluation of the patient experience of symptomatic adverse events on Phase I clinical trials using PRO-CTCAE.

Geoffrey Alan WatsonZachary W VeitchDaniel ShepshelovichZhihui Amy LiuAnna SpreaficoAlbiruni R Abdul RazakPhilippe L BedardLillian L SiuLori MinasianAaron Richard Hansen

Published in: British journal of cancer (2022)

This is the first study to explore patient-reported severity and interference from symptomatic toxicities and compare clinician grading of the same toxicities. The study provided further evidence to support the added value of the PRO-CTCAE in Phase I oncology trials, which would make AE reporting patient-centred. Further work is needed to determine how this would affect the assessment of tolerability.

Keyphrases

clinical trial
patient reported
randomized controlled trial
anti inflammatory
emergency department
adverse drug
phase iii