SDoH data for efficient, patient-centred clinical trials

The social determinants of health (SDoH) are a key component of understanding and delivering better outcomes for patients. Collecting and analysing 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 utilising 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 the most. Achieving representative trial populations requires patient-centred trial designs that remove barriers to participation. The industry is increasingly focused on diversity and inclusion in clinical research, as reflected in the FDA’s recent Food and Drug Omnibus Reform Act of 2022 (FDORA) which builds on 2011 and 2020 guidance in support of trial diversity and patient centricity.

Patient-centricity can significantly contribute to trial population diversity, improve patient experience and maximise retention rates throughout the trial. Analysing SDoH data can provide key insights into developing impactful patient-centred trials by identifying patients with the most need, including underserved and historically underrepresented communities, and can pinpoint key aspects of the patient profiles including even where and how to best engage them, what barriers they face and how they may prefer to overcome them. With these insights enabled by SDoH data analysis, we can deliver more patient-centred trials with representative populations for better real-world outcomes.

Optimising trial design with SDoH data

Patient-centred trials must also be operationally feasible. Analysing 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-centred trial design at multiple stages, enabling optimised protocols and the assembly of digital health technologies and other solutions that minimise 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 behaviours when properly analysed and combined with patient-level claims data. SDoH data analysis can be applied to multilayered 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 customised outreach with compelling, relevant materials that really connect. SDoH data can help sponsors identify, recruit, enrol 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. ICON 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-centred 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 optimise 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

Finally, the transparency afforded by the inclusion of SDoH data allows the investigators, study authors and peer reviewers to better interpret the trial results in terms of their real-world care relevance. When trial and real-world populations align with patient-level and SDoH data, thereby minimising variants between the populations, it facilitates improved confidence that the drug or therapy will perform in the real world as it did in the trial. Conversely, if SDoH data assessments show divergence between the trial and real-world populations, the implications and significance of this difference can be more accurately interpreted. The specific supports, resources or interventions used in the trial to accommodate SDoH-related barriers can be emphasised in interpretation of the trial results to better guide healthcare professionals in real-world applications to improve their patients’ outcomes.

Conclusion

SDoH data, when appropriately analysed, 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.

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