How Lumiio Aligns with FDA’s New Guidance for Better Representation in Post-market Data

In recent years, regulatory bodies have placed significant emphasis on addressing diversity gaps that have long plagued clinical trials. Without a representative patient population in premarket trials, sponsor’s run the risk of regulatory approval and HTA reimbursement challenges. This includes governing bodies requiring post-market studies to further investigate a drug’s safety and efficacy in a population that more closely mimics the demographics that will be using the medication in the “real world”. To help sponsors navigate this process, the FDA recently released draft guidance, underscoring the importance of ensuring the data is representative of the broader patient population who will use the medication. 

Barriers to representative patient populations 

This draft guidance is one of many documents published by collaborative effort across multiple arms of the FDA on promoting the importance of having a representative trial population. While not legally binding, these recommendations points towards the increasing importance of diverse trial samples in approval and reimbursement decisions. Barriers to proper patient recruitment and data collection, however, can make it difficult to produce a representative patient population. These can include historical distrust between certain demographics and research, and the financial and geographical burdens to lower income populations who are often disproportionately impacted by disease. 

The FDA lays out recommendations involving various post-market study avenues to overcome these barriers, including the collection and use of real-world data (RWD). With high quality data sources, RWD can be a more cost-effective and efficient way to address hurdles to patient recruitment and engagement for generating data on efficacy and safety in a representative patient population. This is where companies like Lumiio can support sponsors in the data collection and data generation process.  

The power of RWD for post-market 

Lumiio specializes in gathering, analyzing, and leveraging RWD with a proven track record of long-term patient engagement and diverse patient recruitment. This includes completing prospective data collection and integrating retrospective data collection. With our secure and customizable digital health platform, we collect high-quality RWD sourced directly from targeted patient populations. A crucial aspect to our platform design includes data collection on social determinants of health (SDOH), which are non-medical determinants that impact an individual’s health. This means working closely with sponsors to understand, early and comprehensively, the diversity metrics crucial for their patient population.  

“Patient registries are important tools for many patient groups, particularly rare-disease groups whose patient populations are often spread out and face barriers when accessing clinical trials,” said Victoria Hodgkinson, Chief Scientific Officer at Lumiio. “This is one of the primary goals of many national patient registries including the Canadian Registry for Amyloidosis Research and the MitoCanada Patient Registry. Both specialize in patient recruitment and are working to connect patients with clinical trials they otherwise would have no knowledge of or access to.” 

Integrating SDOH with RWD powers more impactful population analytics and insights and helps to mitigate for gaps in patient-representation in clinical evidence. This data is then more easily translatable into meeting FDA or Health Canada regulations. 

While this draft guidance isn’t legally-binding or tied to mandatory regulations, sponsors who adopt the best-practices outlined and use tools like RWD for pre- and post-market studies open doors for a more efficient and cost-effective approach to achieving representative patient populations – ultimately benefiting in approval and reimbursement decisions. Lumiio can be an important partner in increasing access to-and recruitment of these historically underrepresented patient groups, empowering both medical and patient communities in the drug development process.