PURPOSE: Patient-generated health data (PGD), including contributions to social media sites and patient platforms, can provide a wealth of information regarding the patient experience living with a medical condition and its treatments. It may also provide clues to possible safety signals, benefits and risks, product quality and access. FDA sought to examine the extent to which PGD obtained through social listening could provide information about chronic pain patients’ (CPPs) perspectives regarding the treatment and management of their condition. A recent exploratory project undertaken in collaboration with the Inspire™ patient platform will be presented and implications of results will be discussed. This workshop will include presentations from FDA (CDRH, OMHEE) and Inspire™.

DESCRIPTION: Presentations will highlight the types of information gleaned from social listening and its potential to provide meaningful, actionable insights that can serve as evidence to inform decision making. A brief background and methodology will be discussed, as will data resulting from the following key lines of inquiry:

- Chronic pain patients’ (CPPs) descriptions of pain, its treatment and management

- Common challenges and barriers faced by CPPs, e.g., stigma, perception, health literacy, and treatment access

- CPPs treatment goals and measures of success

- Types of information shared by CPPs and the nature of these resources

- The effect of demographics on these themes

- CPPs experience with mitigating and managing dependence/addiction

Discussion of these topics will lead to greater clarity regarding the benefits and challenges of using social listening to elucidate patient perspective and experience, and its potential for use as scientific evidence in regulatory decision making.