For decades, researchers and government agencies have had their eyes on diversity in clinical trials. On April 13, The U.S. Food and Drug Administration issued a draft guidance recommending that sponsors outline a “Race and Ethnicity Diversity Plan” when submitting applications ahead of clinical trials.
Researchers have gradually improved the diversity of clinical trials. However, as the FDA noted, our country is rapidly diversifying. Meanwhile, health care disparities continue to widen among diverse populations, so the FDA is taking steps to drastically improve diversity in clinical trials to eliminate these gaps and improve treatments.
To design safe and effective treatments, sponsors must study how their drugs impact different populations. It’s more important than ever that sponsors include participants from diverse racial and ethnic backgrounds in clinical trials.
The value of diversity in clinical trials
Studies show that participants in clinical trials don’t often reflect the diversity in the populations likely to use the treatments. White patients comprise the majority of patients in roughly 78% of clinical trials, while women and older adults are frequently underrepresented. In fact, many segments of the population are often left out from trials altogether, with American Indian and Asian people frequently unaccounted for in clinical trials.
Because genetics play a critical role in medical developments, diversity is crucial to creating safe and effective treatments — sponsors and CROs need to take major action toward diversifying their patient pool. Some conditions for which trials are conducted affect certain minority groups more than others. In fact, a 2014 study in Clinical Pharmacology & Therapeutics found "variations in how people from different ethnic groups reacted to around 20 percent of new drugs approved between 2008 and 2013.” The key to increasing diversity in clinical trials is removing the barriers that stop people from taking part in the first place.
Recommended reading: Opportunities for Diversity and Inclusion in Clinical Trials
Common barriers to clinical trial participation include:
- Difficulties getting to the trial site
- Distrust of the medical research field
- Stress about the clinical trial experience
What sponsors should expect from the FDA’s guidance
At a high level, a sponsor’s Diversity Plan should include specific enrollment and retention strategies, site location and access planning, and ways to reduce common trial burdens such as travel and procedures. However, the FDA doesn’t elaborate much further on these points in the draft guidance, leaving the onus largely on sponsors to fill in the gaps when presenting their own plans.
The FDA is accepting feedback on the guidance through June 13, 2022.
To help inform your own Diversity Plan, here are some strategies that can reduce common barriers and increase diversity by utilizing mobile care.
1. We’re going to eliminate the need for patient travel.
A direct benefit to mobile care is that it removes one of the biggest barriers to treatment – transportation. Whether they’re located in a rural or urban area, low-income patients face longer travel distances and higher costs when traveling to clinical trial sites according to research by the NIH. Exacerbating this challenge is the fact that people in underrepresented communities often have difficulty accessing reliable transportation to and from a clinical site.
20/20 Onsite’s Mobile Vision Clinics enable researchers to deliver care directly to patients. Our fully mobile optometry clinics can be staffed with a variety of personnel and outfitted with technology that meets the needs of your unique study. Better yet, our clinics can go wherever your study takes you. Last year, we traveled over 95,000 miles across the country to visit patients.
If you prefer to use familiar clinical sites, our Mobile Vision Clinics can act as an extension of your care team. With support from our team, you can increase staffing at your clinical site. Together, we can help you avoid the pitfalls of staff shortages or site capacities, thus maximizing the efficiency of your clinical trial and reducing the burden on your patients.
Check out our infographic to learn how reducing travel barriers can improve patient recruitment and retention.
2. We’re going to prioritize outreach in historically underserved communities.
By traveling directly to the patient, clinical trials not only remove travel barriers but also increase trust within the community. Patients are more comfortable if care is provided closer to home and with familiar health care providers versus traveling to new places and being treated by strangers. Distrust in the medical field is a major factor in why patients may be reluctant to join clinical trials.
The enduring lack of diversity in clinical trials has caused many people in underrepresented communities to feel forgotten. Additionally, research reveals that over half of African Americans distrust the health care system. The NIH’s discovery of a treatment gap between Black and White patients supports these concerns.
Removing the barriers to care is an essential step in building trust with underrepresented communities. Community outreach is critical to building trust in your clinical trial. A mobile care center demonstrates that your researchers recognize their unique challenges in the community and that you’re committed to easing those burdens.
3. We’re going to make it easier for patients to participate in clinical trials.
Although travel is often a major burden, it’s not the only one clinical trial patients face. Side effects, anxiety, and even forgotten visits are among the most common reasons participants drop out of clinical trials.
In fact, 38% of dropout patients cited stress as a reason they abandoned a trial. Meanwhile, just 16% of patients who completed their clinical trial reported feeling stressed. It's clear that stress is a major factor hindering patient retention.
For rare disease patients, the mental health burdens are even more pronounced. Read our earlier blog to learn more about the struggles of participating in clinical trials as a rare disease patient and How Mobile Care Can Alleviate Rare Disease Clinical Trial Concerns.
Sponsors and CROs can eliminate the stress and confusion that leads many participants to drop out of clinical trials through 20/20 Onsite’s Mobile Vision Clinics. In addition to delivering care directly to underserved communities, our clinics offer a number of benefits that make it easy for patients to participate in clinical trials.
Flexible scheduling alleviates common stresses like finding caretakers for children or requesting time off from work. Plus, our compassionate and multi-lingual personnel communicate openly with each patient to learn about other accommodations we can provide to ensure they have a positive experience.
Bring your research to patients with 20/20 Onsite
20/20 Onsite’s Mobile Vision Clinics travel to rural towns or city centers to make trials more accessible. By taking the study directly to the community, researchers can design better treatment methods to access more diverse patient pools. Contact us today to get started.