Fostering More Diverse Trials Through Targeted Protocols and Other Tactics

Clinical Researcher—April 2020 (Volume 34, Issue 4)


Jody Casey


In its recently released guidance, the U.S. Food and Drug Administration (FDA) has made clear its desire to encourage greater diversity in clinical trials.{1} Diversity in clinical trials can mean more than just race; exclusions can apply to gender, age, sexual orientation, socioeconomic status, geographic location, and even social determinants of health.

Further, a recent article from highlights a phenomenon of overrepresentation of white males in certain cancer studies, which is happening across academic institutions in the U.S.{2} The article states why this is so problematic: Treatments designed with such a narrow sample will not reach a diverse population.

Different populations and age groups respond differently to medications and treatments. This is something that the medical community knows, but that sites may not identify or prepare for within traditional research protocols, which often results in a homogeneous patient base (most typically white males).

Recognizing and Addressing the Barriers

Despite general agreement that diversity brings key benefits to both patients and to the quality of evidence generated, overcoming barriers to including a more diverse population in clinical trials has proven to be challenging.

One critical way for sponsors and contract research organizations to address the lack of diversity in trials is to run protocols within healthcare practices that largely serve minority communities. By bringing clinical care directly to patients in their own communities, trials are more likely to reach a diverse population, including participants who would otherwise be excluded from the research process. This approach enables easier patient access to trials while maintaining the trusted relationship between the patient and the physician.

In Texas border cities like El Paso and Laredo, patients are often unsure of research opportunities outside their current physicians’ practices, and are less likely to seek them out—or to even be aware they exist. Among large populations of immigrants and first-generation Mexican Americans, there is a very real comfort and security associated with their trusted physicians. Having their medical history already on file is important to them, and helps with engagement.

Another reason these remote areas are also largely underrepresented in trials is because patients often don’t have access to reliable transportation, making travel to large academic medical centers, often located hundreds of miles away, inconvenient and cost-prohibitive. This is one of the key barriers to accessing trials.

In addition, there are barriers to entry for local doctors who wish to conduct research. Border communities are generally designated as “underserved,” meaning there’s a worse-than-average doctor-to-patient ratio.

Yet another challenge is the economic impact on patients. Many patients in the working class do not have the extra time required to participate in a study and aren’t allocated time off.

What’s more, the high demand for physicians means most practices don’t have the time, resources, and staff to start up trials on their own. With the burden of time commitments and start-up costs, the pool of healthcare experts and patients currently able to participate in clinical research is not ideal.


By tackling all of these barriers, from both the patient and the physician side, institutions and organizations involved in clinical trials can better pursue their missions of enabling greater access for more patients. Providing healthcare practices with the technology, staff, resources, and infrastructure needed to participate in trials will help to advance better treatments, for more patients, well into the future.


  1. FDA draft memo. 2019. Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry.
  2. Hargreaves B. 2020. White males overrepresented in clinical trials for first-time cancer treatment.

Jody Casey is Vice President, Healthcare Partnerships, Elligo Health Research.