California Initiative to Advance Precision Medicine Addressing the Barriers that Lead to Underrepresentation in Clinical Trials
The factors that serve as barriers for underrepresented populations to participate in clinical trials and how they can be overcome with the combined efforts of stakeholders.
Addressing the Barriers
Participation in clinical trials remains low for many demographic populations. It is important that research activities take into consideration these general factors and minimize the barriers that risk the exclusion of minoritized populations in clinical research. Removing these barriers can break the cycle of health disparities and sub-optimal healthcare for underrepresented populations.
Transportation
Transportation challenges have been identified as one of the most common reasons for non-participation in clinical trials. Research activities that do not offer transportation risk the exclusion of individuals without access to transportation. Underrepresented populations may be living in under-resourced areas away from where research usually takes place. This added burden of travel costs, travel time, or physical obstacles make travel to the research site hard, impacting clinical trial engagement.
One way to meet recruitment and retention goals of a study, improve patient access to clinical trials, and ease the travel burden for participants, is to organize service transfers from home-to-clinic, and any other travel accommodations necessary for the clinical trial.
Researchers can coordinate participant transportation by partnering with reputable rideshare services, such as Lyft and Uber, or with the patient’s insurer, medical provider, or a local community center, to increase convenience and eliminate out-of-pocket expenses for participants.
Financial Barriers & Competing Priorities
It is important to consider the competing priorities related to work and family that participants may be responsible for beyond a clinical trial. It is almost impossible for some people to justify the opportunity cost of participating in a research trial when they don’t see an immediate benefit for themselves, their family, or their community.
Voluntary participation in research is more challenging for participants at or under the federal poverty line due to the nature of the jobs they obtain that offer fewer options to earn paid time off, sick leave, vacation, and access to remote work.
How to address Financial Barriers and Competing Priorities
Decentralized (Virtual) clinical trials can improve a study's participation and recruitment goals because participants can engage from the comfort of their own homes, stick to routine life, and minimize the health risks associated with travel for those who are vulnerable. Technology from smartphones, apps, and wearables are at the core of virtual clinical trials. Technology offers researchers invaluable data about what it is like to live with the condition in question by virtually monitoring daily health data.
Paid clinical trial opportunities can improve a study's participation and recruitment goals by removing financial barriers that prevent patient participation in potentially life extending or lifesaving clinical trials. By using payment systems that are immediate and paperless, researchers can do without the risk for manual errors, and improve patient retention in their clinical trial.
Notes of participation: If a clinical trial requires an investment of time off from their job, providing the participants with an official trial schedule (start date, end date, and frequency of appointments) can improve a study's participation and recruitment goals because they can inform their employer ahead of time and discuss their options for time off.
Cultural Barriers
A diversified outreach strategy is important to clinical trial inclusivity. A clinical trial is not only a time-consuming and stressful process for the individual, but participants may also have unique logistical barriers, such as language and/or mental or physical barriers, that must be accommodated to alleviate some of the stress that members go through.
Linguistic Barriers
Important to clinical trial inclusivity and representation is the arrangement of linguistic accommodations, based on specific patient preference and needs, to avoid additional barriers that might affect trial participation and alleviate some of the stress placed on clinical trial participants.
For More Information
Special thanks to Policy Fellow Bridgette Smith for assembling information for the Equitable Consent webpages.