Patients are using social media — clinical trial experts can learn from that
Since the birth of social media nearly two decades ago, pharma companies have almost exclusively used it as a marketing engine. But, as the adoption of real-world data revolutionizes the field, online networks are now gaining recognition as a bountiful source to understand patient experience and insights.
Throughout their care journey, patients turn to online social communities to discuss treatment options, symptoms and side effects. Recent improvements to artificial intelligence and machine learning capabilities have also made the once-arduous task of combing through social media easier, putting it at the forefront of the industry’s push toward more patient-centric clinical trials.
Regulators are keeping a close eye on these developments. As part of a mandate from the 21st Century Cures Act to consider more experience data during the drug approval process, the FDA published guidance in 2020 with recommendations for how companies could use online platforms to collect patient input.
However, because of vague language in the guidelines, many industry leaders have been hesitant to fully adopt social media as a source of real-world data, said Thierry Escudier, leader of The Pistoia Alliance’s new community of experts investigating social media’s data potential.
“The FDA made statements about the fact that social media can be a source of real-world evidence. But there is some caution and some challenges,” Escudier said. “It’s also up to the pharma industry and those who are helping the pharma industry to make those challenges clearer.”
With that goal in mind, The Pistoia Alliance convened a group of experts in November from across pharma to develop best practices and guidelines for how the industry can use insights from social media as data points during drug development.
“That’s the beauty of (the alliance) is that the least experienced (people) can get the good feedback and the best practice from the most experienced people.”
Thierry Escudier
Community of expert lead, The Pistoia Alliance
“Our focus is to help the R&D teams across the world in pharma, or vendors and technology providers,” Escudier said. “The legal framework we are able to work and operate under is to make people meet and work together for the benefit of both the stakeholder on the industry side, but also on the patient side and the academic side.”
The Pistoia Alliance was conceived in 2007 by leaders from Big Pharma including AstraZeneca, GSK, Novartis and Pfizer to lower “barriers to R&D innovation” by enabling stakeholders from across the industry to work together. The idea for the social media project originated from one of Pistoia’s member companies Semalytix and now includes representatives from AstraZeneca, Bayer, Biogen, Boehringer Ingelheim, Chiesi, Johnson & Johnson and Roche, among other smaller companies.
During the first phase of the initiative, representatives met in roundtable discussions over the last year to share advice on how their companies currently handle real-world data from social media. Now, as they move into an official project phase, they’ll seek input from more alliance members and outside stakeholders — including patients and regulatory agencies — to develop best practices and guidelines for the industry to follow as companies increase usage of social media data.
“That’s the beauty of (the alliance) is that the least experienced (people) can get the good feedback and the best practice from the most experienced people,” Escudier said. “Since this topic can be sensitive, it’s very important that no one is doing the wrong things. That’s why everyone wants to learn from those who have already done it for many years.”
Social media challenges
Top questions the community of experts plan to tackle include how to find data, how to aggregate and analyze data, and how to anonymize data to ensure patient privacy.
One of the biggest challenges companies face with social media evidence is consistency and organization. While some social platforms like Twitter have character limits on posts, there are few rules beyond that — and raw information from these sites can come in a variety of languages and formats.
“There is this famous statement: Garbage in, garbage out. It means that if you don’t know what you get in your database analysis, you will not know what you will get when you want the results,” Escudier said. “If people want to use those social media communications that are absolutely not filtered or formatted by the process of the clinical trial operating model, they may have a lot of (data). But how do you make sure to have (data) that you can analyze?”
Verifying a person’s identity can be another roadblock. In its guidance, the FDA suggested that “to have a verified patient, there should be enough information to indicate the existence of a specific patient, including age, sex, gender, initials, date of birth, name or patient identification number.”
But depending upon the social media site, tracking down these data points may be difficult. And conversely, once the patient data is confirmed, companies must then anonymize the data for analysis. The tedious nature and time commitment of these processes “is why some people still do not want to go into this space, because they might be afraid of how to do it,” Escudier said.
A large part of the alliance’s work will be communicating with regulatory agencies around the globe, including the FDA, to understand what types of social media data they will accept during the drug approval process.
“We want to get in touch with them and say, ‘OK, this is the way we have understood what you are expecting from us. Is it exactly that?’ Once this is agreed upon, (we will) … translate that into best practices,” Escudier said.
Abundant opportunities
Despite the challenges, integrating social media insights with other forms of real-world data and clinical trial results poses numerous benefits for pharma companies.
“The good thing with social media is you access directly what the patient thinks. So it’s complementary to what (data) already exists,” Escudier said.
Patients on social media may be more likely to discuss symptoms and side effects that otherwise might go unreported in a clinical trial. A survey conducted by the Pew Research Center found that 35% of U.S. adults have used the internet to self-diagnose a medical condition, and over a third of those respondents said they did not visit a clinician for a professional opinion.
“There is this famous statement: Garbage in, garbage out. It means that if you don’t know what you get in your database analysis, you will not know what you will get when you want the results.”
Thierry Escudier
Community of experts lead, The Pistoia Alliance
Pharmas can extrapolate information from these daily online interactions to uncover patient insights that they “would never get a sense of through more classical ways of capturing data,” Escudier said.
He also suggested that social media listening could be fruitful “for pharma companies looking to dive into new therapeutic areas” so that they “understand what patients say about their disease,” and can look to fill unmet needs.
By increasing collaboration between industry stakeholders, Escudier hopes the alliance’s community of experts can discover new ways to harness the potential social media could offer in the R&D stages of drug development.
“Alone, you go faster; but together, you go farther,” he said. “When you go with more people, you are sure to have better experience and expertise, and therefore you will be able to go farther. That’s the magic of the alliance.”
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