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.
Connect with us to learn how healthcare intelligence can leverage patient insights to optimise your clinical development strategy.
In this section
-
Digital Disruption
- AI and clinical trials
-
Clinical trial data anonymisation and data sharing
-
Clinical Trial Tokenisation
-
Closing the evidence gap: The value of digital health technologies in supporting drug reimbursement decisions
-
Digital disruption in biopharma
-
Disruptive Innovation
- Remote Patient Monitoring
-
Personalising Digital Health
- Real World Data
-
The triad of trust: Navigating real-world healthcare data integration
-
Patient Centricity
-
Agile Clinical Monitoring
-
Capturing the voice of the patient in clinical trials
-
Charting the Managed Access Program Landscape
-
Developing Nurse-Centric Medical Communications
- Diversity and inclusion in clinical trials
-
Exploring the patient perspective from different angles
-
Patient safety and pharmacovigilance
-
A guide to safety data migrations
-
Taking safety reporting to the next level with automation
-
Outsourced Pharmacovigilance Affiliate Solution
-
The evolution of the Pharmacovigilance System Master File: Benefits, challenges, and opportunities
-
Sponsor and CRO pharmacovigilance and safety alliances
-
Understanding the Periodic Benefit-Risk Evaluation Report
-
A guide to safety data migrations
-
Patient voice survey
-
Patient Voice Survey - Decentralised and Hybrid Trials
-
Reimagining Patient-Centricity with the Internet of Medical Things (IoMT)
-
Using longitudinal qualitative research to capture the patient voice
-
Agile Clinical Monitoring
-
Regulatory Intelligence
-
An innovative approach to rare disease clinical development
- EU Clinical Trials Regulation
-
Using innovative tools and lean writing processes to accelerate regulatory document writing
-
Current overview of data sharing within clinical trial transparency
-
Global Agency Meetings: A collaborative approach to drug development
-
Keeping the end in mind: key considerations for creating plain language summaries
-
Navigating orphan drug development from early phase to marketing authorisation
-
Procedural and regulatory know-how for China biotechs in the EU
-
RACE for Children Act
-
Early engagement and regulatory considerations for biotech
-
Regulatory Intelligence Newsletter
-
Requirements & strategy considerations within clinical trial transparency
-
Spotlight on regulatory reforms in China
-
Demystifying EU CTR, MDR and IVDR
-
Transfer of marketing authorisation
-
An innovative approach to rare disease clinical development
-
Therapeutics insights
- Endocrine and Metabolic Disorders
- Cardiovascular
- Cell and Gene Therapies
- Central Nervous System
-
Glycomics
- Infectious Diseases
- NASH
- Oncology
- Paediatrics
-
Respiratory
-
Rare and orphan diseases
-
Advanced therapies for rare diseases
-
Cross-border enrollment of rare disease patients
-
Crossing the finish line: Why effective participation support strategy is critical to trial efficiency and success in rare diseases
-
Diversity, equity and inclusion in rare disease clinical trials
-
Identify and mitigate risks to rare disease clinical programmes
-
Leveraging historical data for use in rare disease trials
-
Natural history studies to improve drug development in rare diseases
-
Patient Centricity in Orphan Drug Development
-
The key to remarkable rare disease registries
-
Therapeutic spotlight: Precision medicine considerations in rare diseases
-
Advanced therapies for rare diseases
-
Transforming Trials
-
Accelerating biotech innovation from discovery to commercialisation
-
Ensuring the validity of clinical outcomes assessment (COA) data: The value of rater training
-
Linguistic validation of Clinical Outcomes Assessments
-
Optimising biotech funding
- Adaptive clinical trials
-
Best practices to increase engagement with medical and scientific poster content
-
Decentralised clinical trials
-
Biopharma perspective: the promise of decentralised models and diversity in clinical trials
-
Decentralised and Hybrid clinical trials
-
Practical considerations in transitioning to hybrid or decentralised clinical trials
-
Navigating the regulatory labyrinth of technology in decentralised clinical trials
-
Biopharma perspective: the promise of decentralised models and diversity in clinical trials
-
eCOA implementation
- Blended solutions insights
-
Implications of COVID-19 on statistical design and analyses of clinical studies
-
Improving pharma R&D efficiency
-
Increasing Complexity and Declining ROI in Drug Development
-
Innovation in Clinical Trial Methodologies
- Partnership insights
-
Risk Based Quality Management
-
Transforming the R&D Model to Sustain Growth
-
Accelerating biotech innovation from discovery to commercialisation
-
Value Based Healthcare
-
Strategies for commercialising oncology treatments for young adults
-
US payers and PROs
-
Accelerated early clinical manufacturing
-
Cardiovascular Medical Devices
-
CMS Part D Price Negotiations: Is your drug on the list?
-
COVID-19 navigating global market access
-
Ensuring scientific rigor in external control arms
-
Evidence Synthesis: A solution to sparse evidence, heterogeneous studies, and disconnected networks
-
Global Outcomes Benchmarking
-
Health technology assessment
-
Perspectives from US payers
-
ICER’s impact on payer decision making
-
Making Sense of the Biosimilars Market
-
Medical communications in early phase product development
-
Navigating the Challenges and Opportunities of Value Based Healthcare
-
Payer Reliance on ICER and Perceptions on Value Based Pricing
-
Payers Perspectives on Digital Therapeutics
-
Precision Medicine
-
RWE Generation Cross Sectional Studies and Medical Chart Review
-
Survey results: How to engage healthcare decision-makers
-
The affordability hurdle for gene therapies
-
The Role of ICER as an HTA Organisation
-
Strategies for commercialising oncology treatments for young adults
-
Blog
-
Videos
-
Webinar Channel