Leverage Novel Options in Oncology Clinical Trial Design to Reduce Burden For Patients and Sites

The new FDA Patient Focused Drug Development (PFDD) Guidance Series and the Core Patient-Reported Outcomes Measures (PROMs) in Cancer Clinical Trials Guidance demonstrates the industry’s commitment to optimizing clinical trial design, presenting the opportunity to minimize participant and site burden. Traditionally, oncology trials have been solely site-based, with lengthy, complex, and burdensome visits. They have also lacked a standard set of PRO domains and can have high levels of missing data.

Employing flexible approaches to data capture and leveraging technology can help. But, we must ensure they are fit-for-purpose and trial appropriate.

In this webcast, Flo Mowlem, Senior Director, eCOA Science & Solutions at Medable will share insights on how electronic solutions, with a focus on patient-reported outcome (ePROs) can reduce burden on participants and sites to maximize the chance of success in oncology clinical trials.

You’ll discover:

• An outline of the recommended PRO strategy from the FDA
• Knowledge of what domains should be measured in oncology trials to enable full realization of a treatment’s value and facilitate comparison across studies
• Discussion around the new concept of a modular approach – selecting only the relevant items from an existing instrument – for clinical trials
• An understanding on how PROs can be captured outside clinical settings

Speakers

Flo Mowlem, PhD, Senior Director, eCOA Science & Solutions, Medable

Dr. Florence Mowlem is Medable’s subject-matter expert on digitising the capture of clinical outcome assessments (COAs) in clinical trials, ensuring optimal solutions for clients that meet the scientific needs of their studies. She contributes expertise on solution design for all eCOA types (ePROs, eClinROs, eObsROs, ePerfOs, eDiaries) and advises around project complexities, to ensure adherence with the protocol requirements, that industry best practices are followed and regulatory considerations accounted for. Flo is an active member of industry consortium (C-PATH eCOA, DIA), has presented at international conferences and has numerous peer-reviewed publications.

Flo has an MSc and PhD in social, genetic & developmental psychiatry from the Institute of Psychiatry, Psychology, & Neuroscience (King’s College London), where her research focused on sex differences in the diagnosis and treatment of Attention Deficit Hyperactivity Disorder (ADHD), and the psychometric evaluation and validation of a new patient-reported measure for use in adult ADHD.

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Dagmara Kuliś, Associate Head - QOL Department, European Organisation for Research and Treatment of Cancer

Dagmara Kuliś has worked at the EORTC Quality of Life Department since 2009. Her academic background is in languages and translation, but over the years she has developed a broad expertise in PROs.

In her role as Associate Head and QOL Tools Team Leader, Dagmara coordinates a team responsible for the translation of EORTC questionnaires and the Item Library. She is actively involved in the linguistic aspect of developing new questionnaires in the EORTC Quality of Life Group’s portfolio from the linguistic point of view, performing translatability assessment and providing advice on wording and translations. She is also the main point of contact for any queries on the use of EORTC measures as ePRO.

 

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