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.
- 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