Today, we had the privilege of sitting with Mumbi Kairu from The Pamoja Research Institute in Anaheim, California. Mumbi has graciously joined us in Times Square to discuss the FDA’s recent guidance on inclusion, equity, and diversity in clinical trials. Mumbi runs a study site that focuses on diverse patient populations and can speak and represent that group of patients. Today, we’ll explore her insights on the FDA guidance and its implications.
Moe Alsumidaie: Do you feel the FDA’s guidance on diversity in clinical trials addresses the cultural and socioeconomic barriers underrepresented communities face?
Mumbi Kairu: Thanks, Moe, for inviting me. It’s great that the FDA has finally appreciated the need for diversity in clinical trials. However, the guidance is not enough. It’s a starting point but does not come close to addressing the specific cultural and socioeconomic barriers. For instance, the current participation in clinical trials is about 70-75% Caucasian, while the U.S. population is about 51-52% Caucasian. and support to overcome these barriers.
This disparity shows that minority groups are underrepresented. The guidelines encourage sponsors to act without setting clear goals or methods to achieve them. Effective policies and community participation are crucial; the current guidance lacks these elements. We need more than just guidelines; we need actionable steps.
Moe Alsumidaie: How influential are the suggested community outreach measures in your experience? What key strategies might the FDA have missed in its guidance document?
Mumbi Kairu: Let’s start with trust. Building trust is fundamental, and it takes years of consistent effort. I’ve built trust with my patients over 15 years in my clinic. They know me, and that trust makes them more willing to participate in trials. When I recommend a clinical trial, my patients are likelier to participate because they trust me. However, larger academic institutions often lack this personal connection, which is crucial for effective community outreach. The historical mistrust, such as the Tuskegee experiment, still lingers, and the FDA’s guidelines do not adequately address this. We need to start from the grassroots, involving the community and small clinics that have already built trust with their patients. Additionally, we must address practical barriers like transportation, childcare, and job security, which are often overlooked.
Moe Alsumidaie: Not many minority physicians are participating in clinical research. How can this be addressed?
Mumbi Kairu: The big academic structures dominate clinical trials, but we need to involve more community physicians who look like the patients they serve. These physicians often lack the experience big pharma requires, creating a catch-22 situation. Community physicians may have the patient base and the trust but lack the clinical trial experience that big pharma demands. We must support and fund these community clinics to get them involved in clinical trials. This will help build trust and ensure that the trials are more representative of the diverse populations. Training and financial support for these clinics are essential to break this cycle and make clinical trials more inclusive.
Moe Alsumidaie: Is cultural competency training enough to build trust with diverse patient populations, or are there other more significant factors the FDA should have focused on?
Mumbi Kairu: Cultural competency training alone is not enough. You can’t learn a whole culture from a 30-minute slide presentation. Trust and understanding come from long-term engagement and involvement in the community. In my clinic, patients know me by my first name, and we have built a relationship over the years. We need to support community workers and clinics already part of these communities. The FDA’s guidelines are a starting point, but we must go beyond slides and provide real support and resources. This includes funding for community clinics, support for mobile clinics, and home visits to reach patients where they are.
Moe Alsumidaie: Does the FDA provide enough structural support for sites like Pomoja to enhance participant recruitment and retention from diverse populations?
Mumbi Kairu: No, the FDA does not provide enough support. Data collection should go beyond age, gender, and race to include lifestyle and socioeconomic factors. We need to consider factors like homelessness, job security, and access to transportation. We must support communities and small clinics that can reach these diverse populations. Long-term engagement is crucial, and we need to ensure that the benefits of clinical trials reach these communities even after the trials are over. For instance, if a new medication is developed, we need to ensure that it is accessible to the communities that participated in the trials, even if they are on Medicaid or have limited financial resources.
Moe Alsumidaie: Is there anything else you’d like to add?
Mumbi Kairu: We must start from the grassroots and involve the community and small clinics. Diversity in clinical trials should not just be a goal but a reality. We need long-term engagement and support for these communities. Let’s bring clinical trials to the community and train investigators who look like the communities they serve. This is the only way to achieve equity, inclusion, and diversity in clinical trials. We can make a significant impact if we can support small clinics (I have about 3,000 patients who trust us). We need to ensure that these efforts are not just one-time initiatives but ongoing commitments to the communities we serve.
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.
