This forum, geared to all stakeholders with an interest in using real world evidence in Health Technology Assessment (HTA), will focus on the ongoing efforts to solidify Patient-Generated Health Data (PGHD) as a key input into HTA processes. In this panel, we are exploring one type of PGHD; survey or registry data collected directly from patients and/or caregivers or by patient research and advocacy groups, outside of clinical trials.

The panel will explore methods to best capture, analyze, and apply PGHD in value assessment. In many countries, patients have been involved in the HTA process for years, sharing their personal stories to help provide context and deeper meaning to the clinical trial, claims, electronic medical record, and other data sources being reviewed for medical product evaluation. More recently, given the explosion of “big data” across all sectors of healthcare, patient communities have become increasingly interested in the use of PGHD to tell the longitudinal story of disease experience and therapeutic management. Those steeped in HTA methodology have been concerned however about how relevant and rigorous PGHD is or can be in the evaluation process.

The panelists have held multi-stakeholder discussions (including patients, researchers, HTA bodies, industry, and policymakers) prior to this forum will lend insights from those rich discussions. The first two speakers will present promising practices and case studies from their regional roundtables (North America and European perspectives) outlining the use of PGHD in HTA, highlighting the gaps that PGHD can fill, and exploring the barriers they are still working to overcome. The panel will also discuss a potential template for capturing and using PGHD in the HTA process. The remainder of the session will be a facilitated discussion between audience members and panelists, discussing concerns, opportunities, and ideas for more routinely embedding PGHD into the HTA process.