FDA Regulations and Social Media Patient Experience Research

During drug development and later in health care research, researchers study patient experiences and behaviors to better design patient-centered care. Social media narratives i.e. posts made on health forums or social networking sites such as Twitter offer an insight into real-time patient experiences and are considered real-world data (RWD). Most researchers and healthcare professionals made every attempt to follow research ethics or responsible conduct while using social media for research. But a lack of guidelines from regulatory authorities made it difficult to use social media data in an effective manner while maintaining respect for persons, beneficence, and justice in front and center.  

In 2020, the US Food and Drug Administration (USFDA) has published guidelines to include patient experience data in drug development processes. The primary reason to issue these guidelines is to have meaningful patient and caregiver input that can provide valuable insights for medical product development and regulatory decision-making. The FDA has provided guidelines about four different aspects of patient experience-related research methods. Out of these the data collection guideline is relevant to our mission and hence discussed in further detail. 

According to the FDA guidelines, researchers need to be mindful of the locations of data collection (from whom do you get input) and the rationale behind that location (why?). Additionally, they need to be careful about how the information is collected. Along with traditional methods such as interviews, focus groups, surveys, and medical charts, the FDA now acknowledges novel sources like social media along with verified patient communities and digital health technologies as data collection sources. These novel sources can provide data about a patient's day-to-day functioning and quality of life, disease progression, experiences with treatments such as the burden of treatment, patient’s views on different disease outcomes, and impacts of these outcomes.   

The FDA suggests that social media can be used for two main purposes. First, researchers could conduct targeted social media searches using social media tools such as medical community blogs, crowdsourcing, or even social media pages. This might provide valuable information during the early stages of a study to understand the current landscape of the research problem. It can also result in the development of research tools such as qualitative study discussion guides). Another purpose of social media research is to supplement traditional research approaches e.g., interviews, focus groups as mentioned above. Researchers need to be aware of their comparative benefits and limitations.    

When data is collected from verified patient communities and social media, it includes online support groups and online educational groups. From a researcher’s perspective, these groups are useful for gathering information about the disease or current health conditions, information about treatments and experiences of care, and also for recruiting research participants. These groups may include information that identifies patients or other reporters such as caregivers/relatives etc. Researchers must have the authorization to obtain protected health information (PHI) before they collect such data. This can be a limitation as it lengthens the study duration but it is necessary to maintain respect for persons. Another limitation is that since the social media posts are voluntary, the representativeness of the sample can be questioned. In spite of these limitations, social media data can provide ‘robust, meaningful, and sufficiently representative patient input’ and hence is used as RWD for healthcare research.  

An independent survey conducted to study trends in the pharmaceutical industry, in particular opportunities and challenges associated with the use of real-world evidence (RWE) and RWD, revealed that RWE is a strategic priority for pharma companies. These companies intended to focus on evidence related to various topics such as the burden of disease, patient safety monitoring, and comparative effectiveness of treatments. The companies reported benefits of RWD including reduced cost of post-marketing regulatory requirements, label expansion, and recruiting research participants during the pandemic. 

The independent study also reported that a majority of pharma companies have already partnered with other organizations to work on new sources of RWD. The respondents had welcomed the FDA guidelines for further use of RWE and RWD. We too have appreciated the FDA guidelines at Real Life Sciences. Our methods, expertise, and technology to access and analyze new sources of RWD such as social media narratives are in alignment with the FDA guidelines. The RLytics platform can cast a wider net to aggregate data from various disease-specific social media along with general social networking sites such as Twitter or Reddit. The platform is further able to analyze the data using standardized medical terminology, and thus help in answering advanced research questions that cannot be completely answered in a research lab. This opens up exciting new possibilities for research groups who struggle with traditional research methods and want to learn more about the patient journey to focus their efforts on patient centric research. 


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