Patient-Centered Research: Using Patient Experience Data Generated During Drug Development to Inform Healthcare Decision-Making: What Researchers Need to Know to Generate Fit-for-Purpose Data While Considering the Global Picture

ISSUE:

The utility of patient experience data to support drug development remains unclear. The panel including a regulator, a patient, an HTA and an industry representative, will discuss how to build a common framework based on present and evolving notions of fit-for-purpose data.

OVERVIEW:

The Pharmaceutical Industry is increasingly including patients’ views in all stages of drug development. Some regulatory authorities and HTA bodies even go the extra-mile with for example, EMA including patients’ representatives in its committees and decision making processes. As shown with the IMI PREFER’s qualification, both Industry and Regulators are now taking this a step further by leveraging scientific methodologies that enable a more structured patient's input so that patient preferences and outcomes that are meaningful to patients can be systematically considered and captured during drug development. Last year, the ISPOR Task Force on Using Patient Preferences to Inform Decision Making issued a Good Practice report.

This session while involving a regulator, an HTA, a patient and an industry representative, will thus provide a forum to debate, from a variety of different perspectives and experience, whose responsibility is to generate patient experience data, and to discuss potential mechanisms to foster constructive dialogue between stakeholders when generating and assessing such data. The moderator will provide an overview of the activities, opportunities and challenges associated with patients’ experience and preference data generation (10 minutes). The panel will then present their perspectives (10 minutes each), and using case examples will discuss what the future could look like, and whether guidance will be released while also considering the global picture. The moderator will then not only facilitate a debate on areas for harmonization and more operationalized recommendations, but will also oversee a debate between the panellists and incorporate questions/ comments from the audience (10 minutes).