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Patient Diversity in Clinical Trials

Enhancing clinical trial quality through patient diversity, equity, and inclusion

Enhancing clinical trial quality through patient diversity, equity, and inclusion

Achieving and maintaining
patient diversity, equity & inclusion (DEI)

Diversity in clinical research populations is an important focus of stakeholders throughout the industry and regulatory authorities throughout the world.  Medpace has historically promoted DEI in clinical trials 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. All are critical in successfully recruiting and retaining patient populations that accurately reflect the burden of disease.

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Enhancing Clinical Research through DEI

By creating and maintaining patient diversity in clinical trials, we can:

  • Increase the chance of making crucial discoveries that provide 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 disease.
  • Allow us to remain committed to science and maintain data integrity. 

Our Approach to DEI in Clinical Trial Research

Study Approach

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 patient 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 or hybrid 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 

Site Selection

Identity & 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. 

Site Support

Strategies to Support Sites

Sites need ongoing 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 population
    • Support community health fairs to provide screenings and educational information on disease

Patient Outreach

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 incorporating elements of decentralized / hybrid trials (DCTs) in the study design, leveraging  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

A United Approach to Diversity, Equity, and Inclusion in Clinical Research

We approach DEI from a perspective of partnering – Sponsors, Medpace, and Sites committed to working together to achieve diversity, equity, and inclusion in clinical trials. We must unite, as one cannot do this alone. 

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