The social determinants of health (SDoH) are a key component of understanding and delivering better outcomes for patients. Analyzing and analyzing SDoH data including layers of access to care, access to medication, education, employment, socioeconomics, and lifestyle and interests provides new opportunities to improve clinical research across the development continuum, from concept to execution and interpretation of results.
Here we explore how utilizing SDoH can support patients and drive equitable outcomes by informing more precise strategies to reach underserved and underrepresented communities to improve trial populations, data quality and outcomes.
SDoH data for a patient-first approach
Diverse and representative clinical trials are important for developing therapies that are meaningful and relevant to the real-world populations that need them most. Achieving representative trial populations requires patient-centered designs that remove barriers to participation. The industry is increasingly focused on diversity and inclusion in clinical research, as reflected in the Food and Drug Administration's (FDA) Food and Drug Omnibus Reform Act of 2022 (FDORA), which builds on 2011 and 2020 guidance supporting trial diversity and patient centricity.
Patient-centricity contributes to trial diversity, improves patient experience and maximizes retention. Analyzing SDoH data sharpens that approach by helping sponsors identify:
- Patients with the greatest need, including underserved and historically underrepresented communities
- Where and how to best engage them
- The barriers they face
- How they may prefer to overcome those barriers
With these insights, we can deliver patient-centered trials with representative populations and stronger real-world outcomes.
Optimizing trial design with SDoH data
Patient-centered trials must also be operationally feasible. Analyzing SDoH data can provide insights into the best-fit solutions for accessible, diverse trials. Layering SDoH data over traditional patient data helps develop more specific patient profiles that better inform trial design decisions to help fit trial components into patients’ daily lives.
With SDoH data, we can differentiate seemingly similar patient cohorts to dispel preconceptions and accommodate the unique needs of more specific groups. Generating a clearer picture of the cohorts and their barriers to participation allows us to assess the kinds of tools, support, options and resources that will improve accessibility and convenience for each patient. This informs patient-centered trial design at multiple stages, enabling optimized protocols and the assembly of digital health technologies and other solutions that minimize patient burden. Selecting the best-fit and most impactful solutions has the added benefit of avoiding wasted time and resources on irrelevant solutions.
High-impact, diverse patient recruitment
Improved data on the SDoH can generate more significant insights into the challenges patients face and their unique behaviors when properly analyzed and combined with patient-level claims data. SDoH data analysis can be applied to multi-layered patient recruitment approaches that leverage tailored engagement points to capture the target patients for more representative trial populations. We can pinpoint sites and communities that align geographically and demographically with recruitment goals and better understand where these patients are most likely to be diagnosed and how they prefer to be engaged.
Differentiating between similar patient cohorts enables more patient-centric, specific solutions, including customized outreach with compelling, relevant materials that really connect. SDoH data can help sponsors identify, recruit, enroll and retain the patients that could benefit the most from these therapies. For example, a sponsor partner recently wanted to understand underserved populations in ulcerative colitis and Crohn’s disease groups to better define, refine and measure digital media outreach programs to the various patient segments. Symphony Health, a HealthVerity company, incorporated SDoH with other real-world data, linking patient data through our multi-token crosswalk, to identify this key patient segment and monitor the success of the outreach.
Real-world data with patient centricity
More diverse and inclusive trials improve equitable outcomes for patients, and they also provide richer data that is more relevant to the real-world populations the drug is intended for. When patient-centered approaches use SDoH data to create more convenient and accessible trials, it helps improve retention rates and data collection by reducing the likelihood of protocol deviation. It also guides decision-making around patient support services to optimize impact for the specific target populations, including financial, educational or logistical assistance to ensure accessibility. Combined, this improved convenience and compliance results in higher quality, richer data that reflects real-world populations.
Informed interpretation for better outcomes
SDoH data gives investigators, study authors and peer reviewers a clearer lens for interpreting trial results. When trial and real-world populations match on patient-level and SDoH data, teams can be more confident the therapy will perform in practice as it did in the study. When they diverge, the reasons are easier to identify and explain.
That same transparency carries into real-world application. The supports and interventions used during the trial to address SDoH-related barriers can be highlighted in the results, giving healthcare professionals practical guidance for delivering better outcomes to their own patients.
Put SDoH data to work...
When appropriately analyzed, SDoH data has many applications for improving the efficiency and impact of clinical trials. As the clinical research industry increasingly focuses on patient centricity, trial diversity and delivering equitable outcomes, SDoH data will continue to be an important resource for effective trial design and development strategies across the continuum – from design to operations and interpretation of results that drive meaningful progress for patients.
Connect with us to discover how SDoH data can strengthen your trial design.
