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.

Why is this important?

More and more pharmaceutical companies are utilizing social media to get patient insights or Real-World Data (RWD) to produce Real-World Evidence (RWE). While there is very concise regulatory guidance on many other sources of RWE for drug approval and Health Technology Assessment (HTA), the same is lacking for social media as a source of RWD.


Social media and RWE fall under the Pistoia Alliance’s “Empowering the patient in R&D” strategic theme.


Social media poses an interesting and promising method to listen to patients’ voices directly and in real-time, thus capturing unsolicited, first-hand data about the patient experience in large volumes. Moreover, social media listening can be applied to capture the caregiver’s perspective for diseases where patients cannot share their experiences directly. The potential of social media data for carrying out online patient experience research has recently been acknowledged by the FDA in their guidance on “Collecting Comprehensive and Representative Input” and “Methods to Identify What Is Important to Patients” for PFDD. In this guidance, the FDA is doing a balanced assessment by explicitly emphasizing the potential usefulness of social media data to be included in regulatory submissions, while pointing out its potential limitations.


Consequently, the uptake of social media generating RWD as a source for RWE is increasing globally across the industry.


To leverage this huge potential for online patient experience research, automated solutions should be pursued and integrated into the Patient Focused Drug Development (PFDD) chain. Uncertainties surrounding regulatory validity and acceptability resulting from patient experience research need to be mitigated.

How will the project do this?

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.

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