The United States Food and Drug Administration has issued several guidances throughout the last five years to enhance the diversity, equity, and inclusivity of clinical trials. These are significant and much-needed additions to the industry, supporting EmVenio’s mission of providing clinical trial access to diverse and traditionally underrepresented individuals through community research sites. Here’s a look into the last several years of clinical trial guidelines.

Diversity, Equity, and Inclusion
In 2020, the FDA released its final guidance on “Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs,” providing recommendations sponsors of clinical trials can take to increase the number of underrepresented populations in studies. There are three main areas these recommendations touch:

• Broadening participant eligibility requirements.
• Staying engaged with the community.
• Educating staff on cultural competency.

This is especially critical for drugs with the potential to impact more underrepresented populations. The goal is to ensure all trials more accurately reflect the populations who are most likely to use the product.

While this final guidance came in 2020, the FDA has been talking about improving diversity in clinical trials for a while. In a 2018 blog post, it states that when diverse populations are included in clinical trials, medical products are more effective and safer for all people. Trials should include diverse participants from all demographics — ages, races, ethnicities and genders.

In June 2024, the FDA released a draft guidance supporting the creation of Diversity Action Plans to support certain clinical studies. Clinical trial participants should accurately represent the population who will be using the product being tested. These plans are a huge step in the right direction for ensuring everyone has access to potentially lifesaving medical care and increasing safety and efficacy.

Modernization and Innovative Designs
Just as important as increasing diversity in trials are good clinical practices, or GCPs. GCPs are integral to the clinical trial process as they protect trial participants and the integrity of the study. In June 2023, the FDA drafted a guidance aimed at increasing the modernity of trials without compromising GCPs. These recommendations were created to help make trials more efficient and give them the flexibility to change with the landscape. Elements include more innovative trial designs and the implementation of digital health technologies (like wearable sensors), creating a less burdensome process for participants. 

Additionally, the FDA has released a draft recommendation in May 2023 supporting the use of decentralized clinical trials — a major win for decreasing the burdens on trial participants. This would allow participants to visit facilities outside for lab tests instead of the clinical research facility. Travel is a monumental burden for participants, so this guidance is critical for maintaining enrollment numbers.

EmVenio is excited by the industry-wide advancements of the clinical trial space. Many of the guidances being issued by the FDA are implemented across our trial sites. Increasing diversity in clinical trials is at the heart of what we do, and we’re thrilled to see the industry following suit.

EmVenio’s Commitment to DEI

EmVenio is dedicated to improving clinical trial access and participant experience by providing high-quality and convenient support to participants where they live and work. We operate as a proven partner to sponsors and contract research organizations (CROs) to help reach diverse, underrepresented, high-risk, and hard-to-recruit populations.

We focus on placing sites in underrepresented communities where access to and knowledge of clinical research, and oftentimes health care resources in general, are limited. Our sites are more conveniently located to patients, minimizing challenges to participate and remain on studies.

EmVenio deploys a patient-centric, community-driven strategy to engage and recruit clinical trial participants. At the heart of this approach is our commitment to interact with patients and communities on their own terms. We examine the unique dynamics of the communities we enter in order to fully engage with and build trust with prospective trial participants. Our strategy has successfully achieved the following results:

• 44.7% of enrolled participants self-identified as belonging to minority ethnic groups.
  • This percentage increased to 57.5% in our last six completed studies.
• 27 global site locations have an average diverse population that exceeds 50%.

EmVenio’s Modernization and Innovative Designs

By offering a range of visit options, EmVenio successfully balances participant accessibility with high-quality, clinical data gathering. By improving accessibility, EmVenio’s has achieved a 92% retention rate along with achieving 98.5% of study enrollment targets.

By broadening trial accessibility, engaging with different communities, and providing flexible visit options, EmVenio drives inclusivity and diversity within clinical trials that meets and surpasses FDA recommendations. What can we do for your trials?