Advancing patient-centric care: integrating patient reported outcomes for tolerability assessment in early phase clinical trials – insights from an expert virtual roundtable

Summary: Early phase clinical trials provide an initial evaluation of therapies’ risks and benefits to patients, including safety and tolerability, which typically relies on reporting outcomes by investigator and laboratory assessments. Use of patient-reported outcomes (PROs) to inform risks (tolera...

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Bibliographic Details

Published in:	EClinicalMedicine
Main Authors:	Christina Yap, Olalekan Lee Aiyegbusi, Emily Alger, Ethan Basch, Jill Bell, Vishal Bhatnagar, David Cella, Philip Collis, Amylou C. Dueck, Alexandra Gilbert, Ari Gnanasakthy, Alastair Greystoke, Aaron R. Hansen, Paul Kamudoni, Olga Kholmanskikh, Bellinda L. King-Kallimanis, Harlan Krumholz, Anna Minchom, Daniel O'Connor, Joan Petrie, Claire Piccinin, Khadija Rerhou Rantell, Saaeha Rauz, Ameeta Retzer, Steven Rizk, Lynne Wagner, Maxime Sasseville, Lesley K. Seymour, Harald A. Weber, Roger Wilson, Melanie Calvert, John Devin Peipert
Format:	Article
Language:	English
Published:	Elsevier 2024-10-01
Subjects:	Patient-reported outcomes Dose-finding Phase I Phase II Early phase trials Tolerability
Online Access:	http://www.sciencedirect.com/science/article/pii/S2589537024004176