Poster Number P447: How Much Time Do Participants Spend on Completing Quality of Life Assessments in Multiple Sclerosis Trials? – Metadata Analysis
Poster Session 2
Date: Friday, February 24th, 2023
Time: 6:30 p.m. – 7:30 p.m. PST
Location: Pacific Ballroom at Marriott Marquis San Diego Marina
Digitalization in the space of clinical trials allows for the electronic collection of data. This data is needed to demonstrate that a treatment is effective. Participants can use electronic devices to report their experiences with the drug by completing patient reported outcome assessments (ePROs). Quality of life (QOL) reports are especially important because data describing how a patient feels or functions during a treatment with a new drug, helps reach a conclusion of a treatment benefit and support a labeling claim.
PRO instruments identified during review of the QOL articles with the highest number of citations were compared with the QOL instruments most often used in multiple sclerosis (MS) trials. For such QOL instruments, analysis of metadata, specifically time to complete the form, was performed.
Scientific Advisor at Clario
Jowita Marszewska, Ph.D. is a Scientific Advisor at Clario, a global data and technology company that helps minimize risk in clinical trials. Dr. Marszewska has experience with electronic data capture and data management in clinical research. She advises on eCOA best practices, diary and instrument design and training for participants, caregivers and raters. Dr. Marszewska earned her M.Sc. and Ph.D. degrees in the field of chemistry. She has authored or co-authored 10 publications and has been an advocate for STEM education throughout her career.
Director, eCOA Science & Consulting at Clario
Dr. Lindsay Hughes, Director of eCOA Clinical Science and Consulting at Clario, is a scientist and leader with over 15 years of experience in behavioral and life sciences. She has held key national leadership roles including advisor within the Obama/Biden administration’s global HIV response team, advisor to United Nations leadership and instructor at the CDC and USAID. An international speaker, Dr. Hughes is responsible for a team of scientific experts who provide guidance and analysis services related to the creation of electronic data collection systems for clinical trials.