The agency's regulatory mission relies on sourcing new data and methodologies to increase its understanding of patients' perspectives. When Christine Lee, PharmD, PhD, a health scientist with the US Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research, wanted information about caring for her newborn baby beyond what was captured in parenting books, she turned to social media. She joined a forum for new mothers on Facebook to ask the crowd for advice. Soon after, she wondered how social media platforms such as Facebook, Twitter, Instagram, and Reddit can be mined for data that could help the FDA’s pharmacovigilance efforts. “I thought, ‘Could I apply the same qualitative research methods traditionally used for focus groups and cognitive interview data to research involving unstructured narrative data in social media?’ ” explained Dr Lee during her grand rounds presentation, “Structuring Unstructured Data: Using New Data Sources to Understand the Needs of Underserved Populations,” presented May 9, 2019, in Washington, DC. How the FDA Uses Patient Experience Data The agency’s regulatory mission relies on sourcing new data and methodologies to increase its understanding of patients’ perspectives. The FDA uses patient experience data to inform: • Clinical trial design • Trial end point development and selection • Regulatory issues, including benefit-risk assessments To meet patients’ needs, the FDA strives to engage patient stakeholders throughout the life cycle of a medical product. Social media platforms provide a method for capturing meaningful, unfiltered patient insights, according to Dr Lee. It can give the FDA a more comprehensive picture of how medical products function beyond controlled, randomized clinical trials. The FDA has 2 objectives for engaging patients: 1. Support the FDA’s and the Center for Drug Evaluation and Research’s goals of understanding the patient’s voice, including their perspectives on conditions and treatments. 2. Refine qualitative research methods to explore tapping unstructured data with high repeatability. Social Media Monitoring: Gaining Insight Into Diabetes Therapies The US Department of Health and Human Services’ Office of Minority Health funded a pilot study to analyze social media posts for useful data about minority patients with diabetes and their treatment. During the last 2 years, the agency used data-mining software to collect, monitor, and analyze more than 100,000 conversations on Twitter. The effort targeted a variety of keywords, including diabetes, glucose, diabetic, and blood sugar. Demographic filters were added to narrow the query. To separate signal from noise, tweets that were classified as cheeky, advertisements, or spam were removed, leaving about 73,000 tweets for analysis. The remaining tweets were scrubbed and formatted, and then natural language processing and machine-based learning were used to help researchers identify trends. This process was also used to uncover trends in FDA Advisory Committee data, and then the 2 data sets were examined. Improving Diabetes Education Among Minorities Researchers sought to discern what government organizations, patient advocacy organizations, and pharmaceutical companies share on social media, and whether this information is specific to racial or ethnic minorities. The data revealed several content themes: • Awareness: 39.9% of tweets analyzed • Diabetes management: 22.4% • Risks associated with diabetes: 13.3% • Diabetes prevention: 7.3% • Other: 9.1% “We found that little to no discussions on Twitter were specific to minority groups,” Dr Lee said. “Our research suggests that there is an opportunity to improve outreach to minority groups that is specific to their unique health needs.” Researchers also concluded that there are gaps in their understanding of minority groups’ perceptions of the risks associated with FDA-regulated prescription drugs, their unique health needs, and level of health literacy. To gain further insight, researchers mined a sample of Facebook posts from January 2017 to June 2017 that mentioned diabetes. After compiling a list of the top 50 most-liked posts for each month, the content was analyzed to elicit meaning from the collected posts. An extensive codebook was developed to guide this process. The data highlighted the importance of providing a patient-centered approach to care and individualizing care, according to researchers. More specifically, the data demonstrated the importance of: • Educating patients on how diet and exercise can help them manage their diabetes. • Improving patients’ awareness about comorbid conditions and teasing out related symptoms. • Improving awareness about how the link between diabetes and the household environment can increase the risk of developing diabetes. • Providing patient support and encouraging community engagement to promote healthier environments. Although Dr Lee was encouraged by the enhanced patient insight she and her team were able to gain from social media posts, she cautions that social media data must be combined with other sources of data, including FDA archives, patient-focused drug development data, public docket comments, advisory council transcripts, focus groups, and listening sessions. According to Dr Lee, the findings of this study suggest that new data sources can increase the understanding of the patient perspective, particularly of vulnerable populations, and can increase confidence in the data that the FDA traditionally collects. “Social media is a useful data source to gather relevant patient perspectives on barriers and may provide information from populations who may not utilize FDA sources,” Dr Lee concluded. The FDA also conducted a social media listening pilot project on Reddit to gather data regarding opioid use. The results of this study are under manuscript review and cannot yet be shared publicly. Reference Lee C. Gaining insight into the patient’s experience by harnessing the power of social listening and FDA archival data. Presented at: FDA Grand Rounds; May 9, 2019; Washington, DC. Source
