Addressing Clinical Trial Diversity: Challenges, Opportunities, and Critical Capabilities

The 2024 SCOPE Europe conference featured a presentation on clinical trial diversity, highlighting the critical need for diversity and equity in scientific research. Jodie Allen, PhD, Liz Bristow from AstraZeneca, and Magnus Franzen from Wavestone explored the multifaceted reasons why diversity is essential in clinical trials and the strategic steps necessary to achieve it. The discussions highlighted the scientific, business, and ethical imperatives driving the push for more inclusive research practices and the regulatory demands shaping the future of clinical trials globally.

The Importance of Diversity in Science

The speakers delved into the necessity of diversity in clinical trials, emphasizing its role in enhancing scientific understanding and improving research outcomes. They explained that diversity allows for identifying pharmacogenetic markers, which is crucial for understanding how different genetic backgrounds affect drug metabolism and response. This leads to more generalizable and externally valid trial findings, ensuring that results apply to a broader population. Such scientific rigor is vital for providing patients and healthcare providers with confidence in the outcomes. From a business perspective, the speakers noted that trial data reflecting the population expected to use a medical product can lead to significant cost savings. It reduces the need for expensive post-marketing requirement (PMR) studies, often mandated to gather additional data on underrepresented populations, and decreases the risk of regulatory bodies’ non-approval. Regulatory demands are also driving the push for diversity. The FDA now requires Diversity Action Plans with specific, measurable goals, and similar initiatives are being observed globally, with agencies like the MHRA and EMA moving in the same direction. These regulatory changes underscore the global recognition of the importance of diversity in clinical trials.

Patients Deserve Equitable Access

There was emphasis on the ethical imperative of ensuring equitable access to clinical trials for all patient populations. Historically, certain groups have been excluded from clinical research, leading to a lack of data on how these populations respond to treatments. The speakers emphasized that improving trial accessibility for these historically excluded populations is crucial. By expanding access to safe and effective therapies, the healthcare industry can work towards reducing inequities in health outcomes. The speakers provided examples of how certain populations, such as racial and ethnic minorities, women, and older adults, have been underrepresented in clinical trials. This underrepresentation can lead to disparities in treatment efficacy and safety, as the data does not accurately reflect the diverse patient populations that will ultimately use the medical products. By prioritizing diversity in clinical trials, the industry can ensure that all patients have access to therapies proven to be safe and effective for their specific demographic.

Building Clinical Trial Diversity Capabilities

Most of the session discussed the components of a robust clinical trial diversity capability. The speakers stressed the importance of understanding the Intended Use Population (IUP) early in the study planning process. This understanding is crucial for designing inclusive studies that accurately reflect the target population’s characteristics. The speakers shared a detailed case study to illustrate this point. In one example, a clinical trial initially included a BMI criterion that excluded Black non-Hispanic patients due to their higher average BMI. Upon review, it was determined that this criterion had no clinical rationale and was inherited from a previous study phase. Removing this criterion made the trial more inclusive and better aligned with the target population’s characteristics.

Similarly, the speakers discussed adjusting blood pressure thresholds to serve the target population better. Initially, the study had a threshold of 150/95, which was too low for specific racial and ethnic minority (REM) populations. Expanding the range to 160/95 made the study more inclusive without compromising its scientific integrity. Additionally, using local labs for pre-screening were encouraged to simplify complex assessments and make the trial more accessible to diverse populations.

Strategic Site Selection and Community Engagement

The speakers emphasized that strategic site selection and effective community engagement must support inclusive protocol design. They noted that selecting the right sites is crucial for reaching underrepresented populations and ensuring their participation in clinical trials. This involves partnering with sites with strong ties to the community and are trusted by their populations. Community engagement was highlighted as a critical success factor in operationalizing studies that enable underrepresented populations to participate. The speakers pointed out that sites and partners are often better positioned to deliver effective community engagement, as they have a deeper understanding of the local context and can build trust with potential participants. The speakers also addressed the common issue of sponsors focusing solely on patient accrual numbers rather than collaborating with sites to identify and address barriers to participation. They stressed the importance of having open and ongoing conversations with sites to understand their needs and challenges. By doing so, sponsors can work collaboratively with sites to develop solutions that enhance trial accessibility and inclusivity.

Continuous Improvement and Reflection

The session concluded with a call for continuous improvement and reflection in pursuing clinical trial diversity. The speakers shared that AstraZeneca has developed a Clinical Trial Diversity Action Plan (CTDAP) delivery model to ensure consistency and efficiency across its trials. This model includes core roles and enabling functions that support the implementation of diversity initiatives. The speakers emphasized the importance of addressing initial reluctance to set diversity enrolment goals. They encouraged attendees to reflect continuously and embed learnings from past experiences to drive change. This involves reviewing feedback from regulatory bodies like the FDA, comparing plans across the enterprise, and understanding the root causes of any gaps in implementation. By fostering a culture of continuous improvement, the industry can make significant strides toward more inclusive and representative clinical research. The speakers encouraged attendees to assess their clinical trial diversity capabilities and commit to ongoing improvement, ensuring all patient populations can access safe and effective therapies.

Conclusion

The session emphasized that achieving diversity in clinical trials is a complex but necessary endeavor. The industry can make significant strides toward more inclusive and representative clinical research by addressing concerns, building a value story with case studies, and fostering collaboration within a robust structure. The speakers encouraged attendees to assess their clinical trial diversity capabilities and commit to ongoing improvement, ensuring all patient populations can access safe and effective therapies.