Creating and Maintaining Patient Diversity
Diversity in clinical research populations is an important focus of stakeholders throughout the industry and regulatory authorities throughout the world. Medpace has historically been a part of this initiative through our recruitment and retention strategies that encompass study design, site selection and support, and patient outreach and services. It also includes a team philosophy and approach that requires Medpace, the Sponsor and Sites to all work collaboratively toward the goal. One without the other will fail.
Enhancing Clinical Trial Research through DEI
By creating and maintaining patient diversity in clinical trials, we can:
- Increase the chance of making crucial discoveries that provides us with insight on diseases and how to best develop medicines and treatments.
- Understand how treatments work in all populations, especially populations most impacted by the disease.
- Allow us to remain committed to science and maintaining data integrity.
A United Approach to Diversity,
Equity, and Inclusion in Clinical Research
We approach DEI from a perspective of partnering – Sponsors, Medpace, and Sites committed and working together to achieve diversity, equity, and inclusion in clinical trials. We must unite, as one cannot do this alone.
Focus Areas for DEI in Clinical Trials
Identifying Ways to Increase Interest and Accessibility
When DEI is part of the conversation from the onset, the protocol and study design can greatly
impact the ability to enroll a diverse patent population, especially populations most affected by
the disease. Some considerations and approaches include:
- Protocols evaluated with the lens of inclusivity, such as evaluate for ethnic groups, race, older adults, LGBTQ and rural community access and targeting regions based on indication and site regions where populations can be identified
- Study designs that increase accessibility, such as decentralized trials or technology alternatives
- Logistics that consider frequency of visits, location, transportation, and potential financial barriers
- Training of CRO staff to ensure understanding of recruitment objectives and considerations for target patient populations
Identify & Engage Diversity-Oriented Sites and Investigators
To achieve diversity, the Sites and Principal Investigators play a critical role. With decades of
experience and relationships in place, Medpace employs a number of tactics to identify the sites
and the PIs who can help achieve diversity, including:
- What is their geographic location? Are they physically located in an area where the disease is prevalent, and the population is diverse?
- Are the PI and research staff themselves diverse and do they have the cultural understanding
and connection with patients? - Do they have relationships with trusted neighborhood partners such as churches and
community centers?
In addition, as a long-standing member and active participant in the Society for Clinical Research Sites (SCRS), Medpace utilizes their Diversity Assessment Tool (DSAT) to help qualify the ability of a site to execute clinical trials with a diverse subject population. Backed by years of analysis and development, the DSAT allows us to identify quality, diversity-focused sites, as well as provide valuable critiques to reshape the efforts of all stakeholders to push towards higher levels of inclusion in clinical trials.
Strategies to Support Sites
Sites need on-going support throughout the trial to ensure patient recruitment and retention
is successful. Medpace deploys a number of strategies to provide the education, resources and
outreach necessary. Some examples include:
- Education that Aligns on DEI
- Study materials representative of diverse groups. This might include providing multiple versions of materials that represent various patient types.
- Translation services and translated materials available
- Inclusion of DEI topics when discussing recruitment planning prior to activation
- Recommend sites designate a “diversity champion”
- Training and Outreach Programs
- DEI awareness and training programs including cultural competency training with site staff
- Site recognition for enrolling a diverse patient participation
- Support community health fairs to provide screenings and educational information on disease
Listen & Gain Trust
One of the biggest hurdles to recruiting a diverse patient population is a lack of trust across
many under-represented groups. To earn that trust, Medpace uses a number of strategies
and resources, including:
- Provide culturally relevant educational materials such as FAQ documents to help communicate key information and a focus on communicating safety profile and risk/benefits to participation
- Encourage staff to include key family members or caregivers in consent discussions, outreach, and study updates
- Considerations for reducing patient burden such as Medpace’s in-house Patient Concierge Services (travel and reimbursement) and home and tele-health options when allowed
- Partner with communities to connect patients including schools, churches, community centers, grocery stores and pharmacies
- Solicit input from community leaders and advocates
