"Advancing Patient-Reported Outcome Assessment: From Early Phase Trials to Real-World Evidence."
Professor Melanie Calvert, PhD, FMedSci, is the Professor of Outcomes Methodology at the University of Birmingham UK and National Institute for Health and Care Research Senior Investigator. She is Director of the Centre for Patient Reported Outcomes Research which aims to optimize the use of patient reported outcomes (PROs) in clinical trials and routine care, to improve service delivery, enhance patient care and outcomes and ensure that the patient perspective is at the heart of health research and healthcare decision-making.
Professor Calvert has more than 350 peer reviewed publications in journals including the New England Journal of Medicine, Nature Medicine, the British Medical Journal, the Journal of the American Medical Association, and the Lancet. With international collaborators she led the development of international PRO guidance including the SPIRIT-PRO extension, CONSORT-PRO extension, PRO Ethics Guidelines and is a member of the SISAQOL-IMI initiative. Recent work includes publications on inclusive and equitable PRO data collection, use of PROs in early phase trials, reducing participant burden, AI studies and real-world evidence generation. Her highly cited work has informed clinical guidelines, NICE, EMA and FDA guidance and UK Government policy. Professor Calvert sits on a number of international committees leading national and international strategy for PROs research/implementation including the PROTEUS Consortium which promotes tools and resources to optimize the use of PROs in clinical trials to ensure that patients, clinicians, and other decision-makers can make the best decisions about treatment options.
When captured rigorously, patient-reported outcome (PRO) data can provide valuable evidence on treatment efficacy and tolerability from the patient's own perspective. These insights are vital for shared decision-making, allowing for a personalized assessment of the trade-offs between clinical benefits and quality of daily life. Despite their value, high-quality PRO collection and reporting face significant methodological hurdles.
In this seminar, Professor Calvert will explore the challenges inherent in PRO data collection and summarize international guidance designed to standardize implementation. Presenting work from the NIHR Birmingham Biomedical Research Centre and recent work by an ISPOR Taskforce she will examine the strategic use of PROs in early-phase clinical trials and their evolving role in generating robust Real-World Evidence (RWE). Crucially, the session will address approaches to ensure PRO data collection is both inclusive and representative of diverse target populations.
Date: Wednesday, July 1
Time: 11:00 - 12:00 pm ET
Zoom Link: https://wellforce.zoom.us/j/99696982134?pwd=cRXhJr9QOTThhPyThhNIIbXD2xxPAy.1
To be added to the e-mail announcement, please email Kristen LaMarque at kristen.lamarque@tuftsmedicine.org
