FDA Dropped Diversity But Good Science Depends On It

In this conversation, Thad Wolfram, Chief Strategy Officer of EmVenio Research and PCM Trials, shares his insights on the critical importance of inclusivity in clinical research, the impact of regulatory changes, and the role of community-based research in advancing medical science. Research should factor race, age, sex at birth, socioeconomic and demographic diversity. This discussion highlights strategic priorities for the industry, emphasizing the need for trust and broadening reach to drive innovation and improve patient outcomes in clinical trials.

Moe: Earlier this year, the FDA withdrew guidance on diversity action plans, causing uncertainty. How should the industry respond to such mixed signals about inclusive research?

Moe: How are evolving regulatory landscapes regarding diverse patient representation impacting trials, and what strategies can organizations adopt to navigate these changes?

Thad Wolfram: Regulatory guidance increasingly focuses on patient-centric approaches, making participation more accessible. The “four walls of research” concept is expanding beyond traditional settings to include community sites, homes, and virtual environments. This shift mirrors changes in healthcare delivery, where telehealth and mobile health services have become more prevalent. By redefining where and how research can be conducted, we can challenge barriers to participation and make clinical trials more accessible. Organizations should embrace these changes by adopting decentralized and hybrid trial models and leveraging technology to streamline data collection. It’s about meeting patients where they are and making it as easy as possible for them to enroll and remain in clinical trials.

With its varied demographics, the United States offers a unique opportunity to access diverse populations. However, inclusivity extends beyond ethnicity to encompass age, gender, geography and socioeconomic backgrounds. Addressing these factors is crucial for sponsors when selecting sites for clinical studies. Our focus should be on creating equitable access to trials, ensuring that all populations, regardless of their background or location, are represented in clinical research. This approach enhances the quality of data and ensures that therapies are effective for everyone.

Moe: Why is including rural and socioeconomically diverse populations in clinical trials significant?

Thad Wolfram: Including these underrepresented patient populations is vital for several reasons. First, consider the fact that rural populations — who make up roughly 60 million Americans or nearly 20% of the total population — face higher rates of chronic conditions such as cardiovascular disease, diabetes, and opioid addiction. Additionally, cancer incidence and mortality rates are statistically higher in rural areas. However, less than 3% of U.S.-based cancer clinical trials include meaningful rural participation.

Clinical trials are often centered around urban medical centers, so residents of rural areas must travel long distances to and from sites. Considering higher rates of poverty are often found in rural populations, participation quickly becomes difficult if not impossible for many. Rural populations also have lower rates of private insurance coverage and higher rates of uninsured individuals when compared to metropolitan populations. This makes access even harder for this group.

Broader access to these underrepresented participants can significantly accelerate recruitment and, consequently, the time it takes to bring drugs to market. This is a matter of inclusivity for patient data, and a strategic advantage in terms of return on investment for sponsors. Engaging these communities builds trust, which is essential for accepting and using new therapies. By providing access to clinical trials within these communities, we can ensure that the benefits of new therapies reach all segments of the population. It’s about making sure that everyone has a seat at the table.

Moe: What challenges does community-based research help sponsors address effectively?

Thad Wolfram: Community-based research is instrumental in building trust and is crucial for successful patient engagement and retention. By engaging communities and forming partnerships, we can improve health literacy and socio-economic conditions, making clinical trials a more viable option for participants. For example, at EmVenio we’ve achieved a 95% overall patient retention rate by utilizing a scalable community-based research model. This approach improves access and enhances retention and inclusivity, addressing key challenges in clinical trials. It’s about creating a supportive environment where participants feel valued and understood.

Moe: Can you share data on the impact of patient-centric participation on clinical trial outcomes?

Thad Wolfram: Certainly. A recent vaccine study that we delivered for a major sponsor paired community-based sites with mobile clinician follow-up visits. Leveraging this combination, we achieved a 99% patient retention rate, which is significantly better than the industry average of 82%. We also achieved a participation rate among African American/Black participants of 41.7% – more than triple the industry average of 8%. This approach demonstrates the effectiveness of patient-centric participation in improving trial outcomes. Furthermore, a review by GlobalData demonstrates that clinical trials which include mobile clinician visits show higher inclusion rates for Hispanic/Latino participants (90% vs. 59%) and Black/African American participants (55% vs. 48%) when compared to trials which do not offer mobile clinician visits.

By providing convenient access and building trust within communities, we can ensure that participants remain engaged throughout the study. This enhances the quality of the collected data and ensures that the study population represents the broader patient population. It’s about making sure that everyone has the opportunity to contribute to and benefit from medical research.

Moe: Looking ahead, what emerging trends and challenges should be key priorities for the clinical trials industry?

Thad Wolfram: The industry should focus on the areas of greatest need and invest in novel therapeutics and vaccines. While political and economic factors may fluctuate, the long-term strategy of pharmaceutical companies remains focused on patients. The challenge lies in conducting trials for increasingly complex therapies, requiring advanced capabilities to accelerate development. As the industry evolves, it’s crucial to focus on patient-centric approaches and leverage technology to enhance trial efficiency and inclusivity. It’s about staying ahead of the curve and ensuring that we’re always meeting the needs of patients.

Moe: Do you think policy will significantly influence the industry’s trajectory?

Thad Wolfram: While policies may have some impact, the pharmaceutical industry operates on long-term horizons, focusing on global patient needs. The elongated timelines for drug development mean that short-term policy changes are less likely to cause significant shifts in industry priorities. Pharmaceutical companies are committed to addressing the most important unmet needs, focusing on developing therapies that benefit patients worldwide. Regardless of external factors, the industry’s resilience and adaptability ensure that it thrives. It’s about staying true to our mission and continuing to innovate for the benefit of patients everywhere.