A Multilevel Strategy for Diversity in Clinical Trials: Tina Bhatnagar, DO

The push for diversity in clinical trials has emerged as a critical priority within the health care field. Organizations including the National Institutes of Health (NIH) have taken a stance on this issue, advocating for increased representation across the entire clinical trial landscape. Addressing the current diversity gap is a complex, multilevel challenge that requires action at the patient, provider, institutional, and national levels.

As Bhavana (Tina) Bhatnagar, DO, notes in this interview, “It's a big topic right now, and even the NIH has put in a plug to make sure that there is diversity in the clinical trial space.” Bhatnagar is a hematologist, medical oncologist, and associate professor of medicine at West Virginia University Cancer Institute at Wheeling Hospital.

Enrolling individuals from underrepresented backgrounds is an essential first step toward achieving equity in research, and it requires a dual-track educational approach targeting patients and their health care providers. Education is especially vital for doctors who do not practice within large academic medical centers, as they may not be fully versed in the ins and outs of clinical trials. On the patient side, there is a clear need for increased awareness regarding the general importance of clinical research and the specific reasons why enrollment is beneficial for the individual and the community.

Institutional buy-in and the development of local infrastructure are also vital components for success. Currently, much of the existing trial infrastructure is concentrated within academic centers, but these locations may not be the most effective for enrolling minority populations, Bhatnagar says. In clinical practice, many patients show a high degree of hesitation when they are asked to travel to a different facility or a distant location to receive their care. To solve this barrier, clinical trials should be opened within local community hospitals. However, this requires a significant investment in personnel and resources to ensure the trials have the proper infrastructure to be conducted correctly.

Furthermore, the responsibility for diversity may fall on study sponsors to design trials that include a broad spectrum of patients. A major existing barrier is that many trials are currently designed with the intent to enroll only the fittest possible patients, but as Bhatnagar explains, “In the real world, patients have other medical problems. They have other medical comorbidities.”

Future trial designs must account for these real-world health conditions, as well as the practical time commitments and visit frequencies that can prevent diverse patients from participating. By involving community sites in the initial design phase, trials can be better tailored for broad implementation in the community. Building this large-scale infrastructure to support diverse enrollment will eventually benefit the entire field of precision oncology. By collecting data on a diverse patient base over time, researchers will gain a clearer understanding of how specific gene mutations impact different populations and how those groups respond to specific treatments.