Diversity in Clinical Trials: Best Practices for Sponsors

Optimizing clinical trial design is crucial for bringing new drugs to market, but one of the most significant challenges is ensuring diversity within the participant population. Diverse clinical trials are essential for generating reliable, applicable, and safe outcomes across various demographic groups. However, achieving this diversity requires intentional strategies and careful planning.

Why Diversity Matters in Clinical Trials

Recruiting a diverse participant pool is not only a regulatory requirement but a cornerstone of ethical and effective clinical research. Diverse racial, ethnic, gender, and age groups ensure that study findings are generalizable and that the safety and efficacy of new treatments are evaluated across different populations. 

“Some diseases are often disproportionately prevalent in communities that are historically underrepresented in clinical research,” said Alex J. Carlisle, PhD, CEO & CSO of NADPH. “In some cases, these diseases are associated with societal, and even genetic factors, that are distinct within these communities and that drive disparities in disease risk, progression, and treatment, making diversity an imperative.”

A one-size-fits-all approach to recruitment often leads to overrepresenting certain groups, which can skew results and limit the applicability of the trial’s outcomes.

Sponsors increase their risk of oversampling from one patient population, a problem that has collectively and historically plagued clinical trials. This overrepresentation can lead to significant health disparities, where certain populations may not benefit equally from new medical advancements.

“Ensuring that clinical trials are appropriately diverse and as reflective of the entire population as possible is critical to ensuring the broadest and most robust real-world efficacy possible and understanding the potential for adverse events across all populations,” said Dr. Carlisle.

Overcoming Barriers to Diversity

Achieving diversity in clinical trials is not without its challenges. Cultural sensitivities, logistical issues, and regulatory requirements are just some barriers sponsors must navigate. 

To address these challenges, sponsors should consider the following strategies:

1. Tailored Recruitment Strategies: Rather than relying on a single, traditional recruitment method, sponsors should develop targeted strategies that cater to the unique needs and characteristics of different demographic groups. This approach increases the likelihood of engaging a diverse participant pool.
2. Community Engagement: Building trust with underrepresented communities is critical for successful recruitment and requires a long-term community engagement strategy. This can be achieved by partnering with community leaders and organizations with established relationships with these groups. Sponsors should prioritize transparency and cultural sensitivity in all communications.
3. Cultural Competency Training: Ensuring that clinical trial staff are trained in cultural competency is essential for respectful and effective engagement with diverse populations. This training should cover everything from communication styles to understanding different cultural attitudes toward healthcare.
4. Flexible Study Designs: Decentralized and hybrid trial designs can reduce the burden on participants, making it easier for individuals from various backgrounds to participate. These designs leverage digital tools and remote monitoring to minimize in-person visits, increasing accessibility.

Best Practices for Enhancing Diversity

“Any efforts to enhance the diversity of clinical trials should at its forefront include evidence-based models for engaging people with lived experiences, ensure to the best extent possible their inclusion in all phases of the clinical trial development process, and involve honest and transparent dialogue on the history of these communities and clinical trials, with a focus on methods to mitigate harm and maximize value,” said Dr. Carlisle. 

To successfully implement these strategies, sponsors must be intentional in their trial design and execution. Some best practices to consider are:

• Strategic Use of Decentralized Trials: While decentralized trials can be highly effective in improving access for underrepresented populations, they are not a universal solution. Sponsors should carefully consider the therapeutic area and patient population to determine the best approach. For some trials, a hybrid model that combines centralized and decentralized elements may be more appropriate.
• Regulatory Engagement: Engaging with regulators early and often is crucial for ensuring that diversity goals are met and that trial designs are optimized for inclusivity. This includes discussing recruitment strategies and potential barriers to diversity with regulatory bodies during the trial planning stages.
• Ongoing Feedback and Adaptation: Sponsors should be prepared to adapt their strategies based on real-time feedback from participants and regulators. Continuous monitoring of participant demographics and engagement levels allows for mid-trial adjustments that can enhance diversity.

Summary

Much of the need for diversity in clinical trials centers around increasing access and participation for communities that have been historically marginalized within society and largely excluded and even exploited by the clinical research enterprise, according to Dr. Carlisle. Diversity in clinical trials is not just a regulatory requirement; it is a moral imperative that ensures the safety and efficacy of new treatments across all populations.

By adopting tailored recruitment strategies, engaging with communities, and engaging regulators and key opinion leaders, sponsors can overcome the challenges of achieving diversity and conduct trials that truly reflect the diverse world we live in. The future of clinical research depends on our collective commitment to inclusivity and equity in every trial.