Ensuring Patient Diversity in Clinical Trials
In planning. In strategy. In recruitment. In every aspect of inclusive research, we’re all in.
Many patient populations are underrepresented in clinical trials, impacting health equity. The path to approval can be challenging and new regulatory policies designed to ensure data submitted to regulators are representative of real-world populations amplify the pressure for sponsors to deliver. That’s why you need a partner that proactively drives inclusive strategies and solutions, helping your program successfully and efficiently meet regulatory requirements and serve all patient populations who could benefit from your product.
Diversity in clinical trials
The time is now to ensure diverse representation in clinical trials.
Our patient diversity solution
We’re all in to support every aspect of inclusive research
Our comprehensive offering embeds inclusive research solutions curated to meet your needs at every phase of drug development— early phase through post-authorization. Through proactive planning, innovative strategies and solutions, and unparalleled partnerships, you can be confident your trial will meet regulatory requirements for including clinically relevant patient populations on time and on budget.
A dedicated team with an all-in commitment
When you partner with us, you are connected to a dedicated team trained specifically in diverse and inclusive clinical research. Our subject matter experts combine their knowledge of diverse data, cultural competency and engagement, and industry trends with the expertise of a strategic consultancy. Their goal is to optimize your trial design and startup for inclusion, while recruiting and retaining the diverse patient populations that are right for your product.
Collaboration is vital to success. Diverse and inclusive strategies and solutions require an integrated, cross-functional team effort comprised of leading experts across our organization. We work with you to ensure appropriate real-world representation – considering your targets, a comprehensive therapeutic epidemiologic review, and evolving regulatory requirements.
Here are some of the ways we support your diversity and inclusion needs:
Study design optimized for diversity
- Epidemiology and disparity assessments
- Inclusive study design recommendations
- Development and operationalization of FDA diversity action plans
Diversity-ready sites
- SiteCoach training
- Data-driven strategic feasibility
- Training and supporting sites on diversity plans
- Culturally and linguistically relevant site- and patient-facing materials
- Decentralized trial tools
Ongoing patient diversity counsel
Your dedicated patient diversity advisor will keep you informed of any changing global regulatory guidance, as well as site and community updates — giving you the agility needed to stay ahead.
Leverage innovative technologies to facilitate greater clinical trial diversity
We meet patients where they are
For decades, logistical issues have been barriers to participation among diverse populations. Our robust decentralized clinical trial (DCT) solutions ecosystem utilizes technology and support services to make trial participation easier and less burdensome while improving retention and engagement.
Connections with purpose
From participating in industry-wide diversity initiatives to collaborating with national and grassroots organizations, doing more for diversity and inclusion in clinical trials is our driving purpose. We cultivate industry collaborations and partnerships with community-based organizations that develop, maintain, and sustain meaningful, long-lasting relationships – bringing you closer to in the communities you seek to serve.
Furthermore, we recognize that sites are often the “face” of your trial. That’s why we actively identify high-performing site networks with investigators who are already serving diverse patient populations – delivering an inclusive experience to patients that is second to none.
An inclusive mindset complemented by comprehensive diversity services
Our early planning efforts and strategic guidance are amplified by a robust suite of services designed to:
- Center on the right patient demographics, the right sites and the right innovation to overcome barriers to participation
- Ensure the data gleaned accurately aligns with the patients intended for your product
Learn more about curated solutions to drive inclusion of real-world populations in your study
Decisions guided by data
Want to better define strategies that optimize feasibility and study design? Our data dashboard unlocks insights at a granular level, better defining strategies to enroll diverse patient populations at the site and community level.
- Truecast and TriNetX diversity data provide an evidence-based strategy to target more diverse sites and patient populations.
- Our proprietary mapping tool overlays sites on regions of the U.S. using 2020 census data to show the non-white race/ethnicity that is most prevalent in every zip code.
- We provide study teams with epidemiology at a race/ancestral level, supplemented with our team’s experience in public health research.
Optimizing sites that are embedded in diverse communities
New sites? No worries. SiteCoach, our proprietary training program, trains and supports research-naïve sites to conduct successful clinical trials, access untapped patient populations and bring clinical trials to the community.
An inclusive environment increases engagement
Reaching diverse, underrepresented patient populations is challenging; engaging them throughout the clinical trial journey goes a step beyond. We can support patients at every step of their journey with services like a clinical trial hotline, screening and referral services, patient concierge, reimbursement strategies, and more. Taking time off from work deterring them? Need home health care services? We actively work to resolve patient barriers to enable more people from underrepresented groups to participate and stay engaged throughout their clinical trial.
When it comes to inclusive research, we’re all in. Are you?
Schedule a meeting to discuss real-world patient representation for your clinical trial.
Photo credit: Shutterstock Studios, in partnership with the DREAM (Driving Racial Equity in Aesthetic Medicine) Initiative®