Driving Inclusion in Clinical Trials: Less Talk, More Trust

Gadi Saarony, CEO, Advarra

Stripped down to its fundamentals, drug development requires diverse participant representation for safe and effective treatments. But “diversity” has much broader implications. As an executive with more than two decades in the industry, I’ve seen firsthand that diverse voices from employees, customers, and partners enhance the research ecosystem. Greater diversity leads to higher quality research and evidence—which ultimately leads to better health outcomes for more people.

There’s a lot of talk about diversity, equity, and inclusion in clinical research—but it all really comes down to a single word: trust.

Pathways to trust

Regulators play a vitally important role that’s evolving in real-time. In 2023, Congress passed requirements in the Food and Drug Omnibus Reform Act that require drug and medical device manufacturers to submit diversity action plans to the FDA ahead of pivotal clinical trials.¹

In June 2024, the agency updated its 2022 guidance recommending the use of diversity action plans to increase clinical study enrollment of participants of historically underrepresented populations.² The 2024 draft guidance provides more details and specific recommendations to support clinical trial sponsors in creating and submitting diversity action plans for certain studies.³

However, diversity can’t just be regulated top down. In addition to the influence of federal and local regulators, we need to repair the underlying damage from decades of maltreatment to establish confidence between underrepresented patients and the system. And it requires grassroots strategies.

Let’s step up efforts to diversify our clinical investigator population, especially in community sites reaching underrepresented patients. The more patients can see themselves in the people manning these key positions, the greater the chance of establishing trust and increasing their participation. Train inexperienced researchers on the nuances of the populations they are serving up front, too. For example, Beacon of Hope is a private sector partnership with historically black colleges and universities⁴ focused on training the next generation of physicians and nurses—and, hopefully, research investigators.

Another approach is for sites to tailor their recruitment strategies to the needs and preferences of the community where they enroll patients. They can partner with local church and community leaders to create trusting relationships with potential participants, for instance. This was proven during the COVID-19 vaccine trials, when inclusion of underrepresented populations through community engagement boosted trust, and, in turn, participation rates. Connect partners and researchers together to engage directly with communities of color and improve diverse participation. Acclinate, for example, successively partners with researchers to engage directly with communities of color and improve diverse participation.⁵

Institutional review boards also play a critical role in trust by ensuring each research project includes an equitable inclusion and selection of participants.

Tech’s overlooked role

Often underrecognized, technology that puts the participant first is a key component for building trust. For instance, technology that simplifies participation and keeps patients informed and in control increases their confidence in the process. Here are four ways technology can bridge the trust gap:

• Communication. Patient engagement platforms provide educational materials in various interactive formats and languages, automated appointment reminders, and real-time access to trial information.
• Remote modalities. Telemedicine and virtual visits provide more opportunities for interactions between researchers and participants, helping to build personal relationships with bidirectional communications.
• Alternative data collection. Wearable devices and other technologies provide alternative ways to collect real-world data, making it easier for people to participate, with fewer study visits.
  Additional measures of data security and privacy. Clearly communicating how data will be stored and anonymized is crucial to alleviate fears of data misuse.

The journey to inclusivity in clinical research will take time and commitment. I believe that trust is the key to unlocking this heavy door, and we can build trust through strategic partnerships, thoughtful initiatives, and innovative technologies that prioritize participants. Bridge the trust gap, and we can change the face of clinical research and the state of human health, improving outcomes.

Gadi Saarony is CEO of Advarra

References

1. Congress Enacts Legislation Requiring Guidance on Clinical Research Diversity and Modernization. Ropes & Gray. January 9, 2023. https://www.ropesgray.com/en/insights/alerts/2023/01/congress-enacts-legislation-requiring-guidance-on-clinical-research-diversity-and-modernization

2. FDA, Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry (April 2022). https://www.fda.gov/media/157635/download

3. FDA, Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies (June 2024). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/diversity-action-plans-improve-enrollment-participants-underrepresented-populations-clinical-studies

4. Keenan, J. Novartis Adds More PartnersIto Beacon of Hope initiative for HBCUs and Clinical Trial Diversity. Fierce Biotech. July 13, 2023. https://www.fiercebiotech.com/cro/novartis-adds-more-partners-beacon-hope-initiative-hbcus-and-clinical-trial-diversity

5. 8 Best Practices for Increasing Diversity in Clinical Trials. Acclinate. YouTube. https://www.youtube.com/watch?v=6ez_vXt3OtI