Clinical trials are the bedrock of medical advancement, but they often grapple with a persistent challenge: ensuring diverse and representative participation. This issue isn’t just a matter of ethics—it’s crucial for delivering effective, equitable healthcare solutions.
Historically, clinical trials have failed to represent the populations they aim to serve. Certain groups—particularly by age, race, ethnicity, and sex—are often underrepresented. This lack of diversity results in findings that may not be generalizable or reflective of the real-world patient population.
Recent guidance from the U.S. Food and Drug Administration (FDA) emphasizes the importance of creating diversity action plans in clinical research, mandating the inclusion of broader demographic groups to ensure safer, more effective treatments for everyone. Despite these regulatory advancements, many organizations still struggle to effectively integrate diversity and inclusion into their trial designs.
The Big Questions
- Can trial designs truly reflect the diverse fabric of the global population?
- What’s the cost of not diversifying clinical trials?
- How can real-world data (RWD) enhance trial design?
This is where TriNetX’s innovative approaches like patient-centric design, global RWD, and advanced analytics come into play to help solve the diversity and inclusion challenges sponsors and contract research organizations (CROs) face.
I’ll be representing TriNetX at the podium at SCOPE 2025 where I’ll deep dive into these innovative approaches and share strategies you can employ to ensure your clinical trials are inclusive and meet diversity goals and guidelines. Here’s a sneak peek into what you can expect during my session, “Putting Patients at the Heart of Research: Transforming Trials Through Inclusive Design.”
1. Understanding the FDA’s Diversity Guidance
I’ll cover how you can align with the latest FDA requirements for diversity action plans, including:
- Setting enrollment goals stratified by age, race, ethnicity, and sex.
- Implementing strategies to meet these goals without compromising scientific rigor.
2. Leveraging Data for Inclusion
I’ll share how to use RWD to identify and recruit underrepresented populations and discuss TriNetX’s extensive global health research network, which covers 283 million patients, enabling detailed demographic analyses to ensure inclusive trial designs. With the TriNetX LIVE™ platform, researchers can access robust data on patient demographics, comorbidities, and treatment patterns to refine trial designs.
3. Transforming Trial Design with Patient-Centric Approaches
We’ll explore how tailoring trial protocols can eliminate barriers to participation, making it easier for diverse groups to contribute to research. Case studies will demonstrate the tangible impact of inclusive designs on recruitment, retention, and overall trial success.
4. Real-World Success Stories
I’ll detail how organizations TriNetX has partnered with successfully integrated diversity into their trial strategies, overcoming challenges like restrictive eligibility criteria and enhancing outreach to underrepresented groups.
5. Future Trends in Clinical Trials
I’ll provide insights into emerging trends that are shaping the future of patient-centric trials, from automation and advanced analytics to community engagement and cultural competency.
Be Part of the Change
Don’t miss this opportunity to put patients at the heart of your research — because a truly inclusive approach is the foundation of effective, impactful healthcare. I hope to see you at SCOPE 2025!
Putting Patients at the Heart of Research: Transforming Trials Through Inclusive Design
Date: February 5, 2025
Speaker: Akiko Shimamura, Senior Vice President of Trial Design & Optimization, TriNetX
Time: 9:55 am (within Track C1: Patient-Centric Trial Design & Inclusive Research)
Discover more about our presence at SCOPE, and book a meeting with our dedicated team
Unlocking the Future of Inclusive Clinical Trials
At TriNetX, we’re advancing diversity in clinical trials through:
Unparalleled Access to RWD
With the largest global health research network covering 283 million patients, TriNetX delivers real-time insights into patient demographics, comorbidities, and treatment patterns. These capabilities enable researchers to assess trial feasibility, identify diverse patient cohorts, and align their designs with real-world clinical practice.
Actionable Diversity Insights
TriNetX’s tools allow researchers to analyze and refine eligibility criteria through a “diversity lens.” This approach ensures that protocols are inclusive and scientifically sound, addressing barriers that historically excluded underrepresented populations.
Streamlined Recruitment and Retention
By leveraging advanced analytics and targeted site identification, TriNetX helps organizations locate and engage healthcare sites that align with diversity goals. This strategic approach improves recruitment, enhances retention, and ultimately delivers more representative study populations.
About Akiko Shimamura
Akiko is an experienced leader in the life sciences industry, having held a range of senior roles. As Senior Vice President at TriNetX, she is responsible for developing products and managing teams focused on trial design and optimization. As the former Vice President of Medidata, she has overseen products across real-world evidence (RWE), commercial analytics, and tokenization. Akiko has a wealth of experience in consulting having previously worked at McKinsey & Company where she provided advice to companies on life sciences and analytics.
