By Jen Lamppa, Ph.D., Associate Vice President, Clinical Analytics, Inovalon
LinkedIn: Jennifer (Tate) Lamppa, PhD
LinkedIn: Inovalon
Clinical trials have a diversity problem. Despite years of effort, the participants in many studies still fail to reflect the true demographics of the populations they aim to serve. The consequences are profound: limited applicability of results, missed insights, and health inequities that persist across generations.
The missing piece? A deeper understanding and integration of social drivers of health (SDOH).
Remarkably, 80% of health outcomes are influenced by a patient’s SDOH, including economic conditions, education, and the physical environment.
By incorporating SDOH into various stages of the clinical trial life cycle, researchers can design more inclusive studies that enhance participant diversity and improve health outcomes for all populations.
Diversity at the center of clinical trials
Integrating SDOH into clinical trial planning and design is crucial for achieving health equity and enhancing the overall effectiveness of healthcare interventions.
Despite ongoing efforts, some racial and ethnic groups, along with individuals from lower socioeconomic backgrounds, remain significantly underrepresented in clinical trials.
As depicted in a 2020 report:
- African Americans, who represent 13.4% of the U.S. population, made up only 8% of clinical trial participants
- Hispanic/Latino individuals, constituting 18.5% of the population, accounted for just 11% of trial participants
This disparity is exacerbated by the lack of socioeconomic status (SES) reporting in trials. Without this data, the generalizability of research findings is limited, hindering the development of tailored interventions for lower SES groups.
The importance of SDOH in clinical trial diversity
The role of SDOH in enhancing trial diversity is critical; neglecting these factors perpetuates existing health disparities and can lead to trial endpoints that don’t accurately reflect real-world outcomes.
By prioritizing diversity and inclusivity throughout the product life cycle, researchers can:
- Create relevant trial designs: Develop trial designs that genuinely reflect the needs of diverse populations
- Enhance patient recruitment: Identify and engage with diverse populations to improve participation rates
- Address barriers to participation: Tackle the obstacles that prevent underrepresented groups from participating in clinical trials
Designing diverse clinical trials
Comprehensive endpoint selection
When designing clinical trials, consider endpoints that reflect the diverse needs of the patient population.
Traditional endpoints often overlook the impact of SDOH on patient experiences and outcomes, leading to a limited or misleading understanding of treatment safety and efficacy across different demographic groups.
By including endpoints that account for socioeconomic factors – such as income, education level, and access to healthcare – researchers can gain a deeper understanding of how new treatments perform in the real world and across different demographics.
For example, a trial for a diabetes medication could assess clinical outcomes as well as how socioeconomic status affects medication adherence and access to care. This approach provides a more comprehensive view of the treatment’s effectiveness across diverse populations.
Flexible and accessible trial design
Diverse clinical trial designs must accommodate the realities of participants’ lives. Key accommodations may include:
- Geographic accessibility: Selecting trial locations that are easily accessible to diverse populations
- Flexible scheduling: Offering appointments at varied times to fit participants’ work and family commitments
- Participant support: Providing assistance, such as childcare services or transportation options, to ease participation barriers
- Inclusive criteria: Expanding eligibility criteria to include a broader range of patients to be more representative of the general population
By implementing flexible and accessible trial designs, researchers can create inclusive environments that encourage participation from diverse populations.
Modification of protocols
To accommodate SDOH variables effectively, researchers should be prepared to modify trial protocols as necessary.
Adjusting inclusion criteria or trial methodologies based on real-world data and SDOH insights can help ensure that studies are more representative of the populations they aim to serve.
For example, if data reveals that certain demographic groups are underrepresented due to transportation issues, protocols can be adapted to include remote participation options.
Recruitment strategies for clinical trial diversity
Building inclusive populations
Achieving diversity in clinical trials is not merely a regulatory requirement; it is a critical component of effective research.
Researchers can leverage deep population segmentation data and analyze disease treatment patterns to build inclusive patient populations. This approach helps accurately identify target populations that reflect the demographic and clinical characteristics of the broader community affected by the disease.
Utilizing extensive datasets enables researchers to pinpoint underrepresented groups in clinical studies. By understanding the locations and characteristics of these populations, researchers can develop targeted recruitment strategies that are both efficient and effective.
Addressing barriers to participation
Barriers to clinical trial participation often stem from various social risk factors that hinder healthcare access and care quality. Identifying these factors enables researchers to mitigate barriers and enhance patient care.
Key challenges include:
- Transportation issues: Lack of reliable transport to trial sites
- Economic barriers: Financial burdens, such as travel costs and lost wages
- Language barriers: Limited English proficiency affecting understanding of trial information
- Health literacy: Variations in health literacy may hinder comprehension of trial protocols and risks
- Access to information: Lack of awareness about available trials, especially in underserved communities
Addressing the various barriers to participation is essential for fostering equitable access to clinical trials, ensuring that all demographic groups can contribute to and benefit from research advancements.
A call for change
Achieving true diversity in clinical trials is not just a regulatory checkbox; it’s a scientific imperative. By integrating SDOH throughout the trial process, researchers can build more representative study populations, enhance data validity, and ultimately bridge the gap in health disparities and contribute to more equitable healthcare outcomes.
This article was originally published on the Inovalon blog and is republished here with permission.