There has always been a need for diversity in clinical trials. Whether that diversity is in age, race, ethnicity, socio-economic status, geography, sexual orientation or other factors, diversity is often required to make sure the participant population of a study represents a wide variety of people in order to prove the effectiveness of a drug or treatment across underrepresented groups. A lack of awareness and access to clinical trials by underrepresented groups could lead to the risk that new therapies and treatments might underperform with those population segments.
Although needed, diversity in trials is a hard thing to accomplish for a variety of reasons. In fact, simply filling studies is a difficult task. According to Mira Desai in an article published in the National Library of Medicine, an estimated 80% of clinical trials across the country fail to enroll enough patients on time. There is a concern that adding a diversity mandate could create even more difficulty in filling and completing studies.
The DEPICT Act
The Diverse and Equitable Participation in Clinical Trials (DEPICT) Act requires pharmaceutical and biotech companies to submit diversity action plans for clinical trials. The act was passed by Congress in December 2022.
The DEPICT Act requires the following:
- Reporting Enrollment Goals: Report enrollment targets by demographic subgroup (age group, race, ethnicity).
- Provide Rationale Behind These Goals: Provide information about the condition being researched and its prevalence and/or incidence among various demographic groups.
- Action Plans: Detail the diversity action plan to reach enrollment targets.
By December 2023, the FDA will issue guidance on the format and content of these plans.
Ways to Reach a More Diverse Population for Studies
There are a number of ways that clinical research sites, such as Aim Trials, can ensure they are reaching a more diverse population.
Technology can be utilized to increase the geographic reach of research studies. The use of telemedicine, wearable tech and biomarkers can extend geographic reach to rural communities, aged populations, and those not able to visit on-site for other reasons. Connectivity tools can be used to bridge this gap, but often aren’t enough to conduct a study and may be difficult for some participants to understand.
On-the-ground community involvement is a way to reach racial and ethnic groups. Participating in medical and educational outreach directly to these communities can put a clinical site in contact with groups they would not normally reach.
Some marketing for studies can be targeted to specific groups through advertising and data gathering methods. There are growing challenges with media targeting, however. Most media channels no longer allow targeting by race, ethnicity or sexual preference. Many are also limiting age targeting below the age of 18. “Old School” targeting, such as by format, content or media choice, may have to be re-embraced as a way of targeting these groups where digital data is now limited.
The FDA will impose standards for researchers and pharmaceutical firms to list their demographic goals for their participant pool, the rationale for their goals and an explanation of how they intend to meet them.
How Aim Trials is Achieving Diversity as a Clinical Site
At Aim Trials, we have always strived for diversity within our clinical trials where applicable or possible. Aim Trials has been actively part of the community participating in different events throughout the DFW metroplex. We have Physicians and Coordinators that speak different languages such as English, Spanish, Korean and Hindi. The DEPICT act may now require it, but we’ve always felt reaching a diverse population is the right thing to do.
Our Diverse Population Database
Our site has experience conducting trials in both pediatric and adult populations in both low and high-volume studies. We hold a diverse population of patients in our database with 35% Caucasians, 30% African Americans, 15% Asians, 15% Hispanics, 1% American Indians and 4% other.
Why Aim Trials When Considering Diversity as a Goal?
Having a diverse population in our database at Aim Trials and having experience working across a wide range of studies is of great benefit to us and to our customers.
First, we are able to complete studies as a single clinical site, without having to engage other sites across the country to find the populations needed for a study. Second, we are very experienced working with adolescents, an often-underserved group. Third, the large population in our geographic marketplace (Dallas Fort Worth Metroplex) allows for an immense and varied audience to choose from. Fourth, our diverse database and reach allows Aim Trials to work with a larger set of pharmaceutical companies for their trials knowing our current population and capabilities. Finally, when conducting vaccine studies, an important category at Aim Trials, we are better able to reach the diverse market needed to create equitable results across demographics and populations.
Aim Trials as a Research Partner
Aim Trials meets the standards and can be a great choice if you are searching for a partner that supports diversity in clinical trials. We strive to continue our outreach for diversity and invite you to learn more about Aim Trials as a partner to conduct a clinical trial, or as a participant in one of our studies.