Social Media & Real-World Evidence

Project Charter

The goal of the Social Media to Produce Real-World Evidence (RWE) project is to develop and publish key regulatory guidelines associated with the use of social media as real-world data (RWD) to produce RWE.

Challenge

Pharmaceutical companies increasingly use social media to gather patient insights and Real-World Data (RWD) for Real-World Evidence (RWE). While regulatory guidance exists for other RWE sources, it remains sparse for social media as an RWD source.

Social media aligns with the Pistoia Alliance’s “Empowering the patient in R&D” strategic theme, offering a real-time method to capture patient and caregiver perspectives on health experiences. The FDA has acknowledged social media’s potential for patient experience research in its guidance on “Collecting Comprehensive and Representative Input” and “Methods to Identify What Is Important to Patients.” However, the FDA also highlights its limitations.

As social media-generated RWD gains traction globally, automated solutions must be integrated into the Patient Focused Drug Development (PFDD) process. Addressing uncertainties about regulatory acceptance is crucial to realizing its full potential.

Project goals

This COE proposes to collaborate on strategies to identify and resolve issues with the intent to maximize the benefits of utilizing online patient experiences as RWD leads to RWE. A goal is to develop these strategies into industry standards and propose them to regulatory authorities such as the FDA and EMA for approval.

Regulatory approval will create trust and reliability needed for industry adoption of these standards to implement patient experience research as an integral tool in their PFDD chains. Participating members benefit directly through the facilitation of an innovative, scalable approach for broad, strategic use, making the patient voice actionable in PFDD.