MedCity Influencers, Pharma

Diversity in clinical trials: An issue that we can no longer ignore

Minorities—along with the elderly and women—have historically been underrepresented in clinical trials.

Composite image of a large group of diverse people smiling

In a blog post in early 2016, the U.S. Food and Drug Administration Commissioner Dr. Robert M. Califf shared the agency’s intent to make 2016 “The Year of Diversity in Clinical Trials.” In doing so, Califf acknowledged FDA’s awareness that certain groups of patients may respond differently to different therapies and that “a wide range of people should have the opportunity to participate in trials, both for access to new therapies and to have the chance to contribute to better treatment of everyone.”

As FDA notes, minorities—along with the elderly and women—have historically been underrepresented in clinical trials. African-Americans, for example, comprise 13.2 percent of the population, but only 5 percent of clinical trial participants, while Hispanic patients represent 16 percent of the population, but just 1 percent of participants. Meanwhile, Caucasians account for 67 percent of the population and 83 percent of research participants.

As medicine becomes more precise, researchers are increasingly aware of the importance of ethnic diversity to understand the full impact of certain drugs. We now recognize that different ethnicities respond differently to the same disease, and respond differently to different therapies. Consider the blood thinner clopidogrel, or Plavix, which FDA approved in 1997. Today we realize that about 50 percent of Asian patients and 75 percent of Pacific Islanders lack the enzymes required to activate the drug.

Similarly, certain classes of hypertension drugs have recently been found to be less effective in African-American patients, while African-Americans with a certain common genetic variation require lower doses of the blood thinner warfarin compared with Caucasian patients.

The inclusion of multiple ethnicities is essential in the clinical trial process for these reasons, and also because all patients should have equal access to opportunities for advanced care funded by clinical trial sponsors.

Getting to the root of the problem

The two primary reasons for low participation rates in clinical trials among minorities are feelings of mistrust among potential participants and an overall lack of awareness due to inefficient recruiting methods. Both of these issues need to be addressed to begin moving the dial on recruitment and enrollment of minority patients.

The mistrust is based on a well-documented history of unethical clinical research, especially the U.S. Public Health Service’s Tuskegee syphilis study. The study induced 600 African-American men to participate in various experiments over a 40-year period. Participants who were diagnosed with syphilis were never informed of their condition, nor were they offered treatment. Many died of the disease, infected their wives, and/or passed congenital syphilis to their children. As a result, residual mistrust of clinical trials remains today among many members of the African-American community.

Unfortunately, even though awareness of the need for more minority patients in clinical research has increased, traditional clinical trial recruiting methods have not been effective in terms of increasing the pool of minority participants. In fact, traditional recruitment methods that rely heavily on direct-to-consumer marketing such as Google ads and billboards to attract patients are failing to keep pace with trial demands in general—regardless of ethnic background. They fall even shorter when it comes to ensuring clinical trial diversity. Even with the widespread use of radio, television, and social media, nearly 70 percent of all clinical trials experience delays as a result of recruitment issues.

How we can do a better job together

As an industry, we need to do a better job informing potential participants of all racial and ethnic backgrounds about available clinical trials. At the company I lead, ePatientFinder, we have found that getting physicians more involved in the recruiting process, rather than relying on direct-to-consumer marketing, encourages greater patient access and participation. We recognize that community physicians have historically had little visibility into active studies, and we also have learned that patients are more likely to participate in clinical trials if their doctor recommends them.

The wide-spread adoption of EHRs and the growing availability of sophisticated analytics is making it easier to leverage the trusted physician-patient relationship and more accurately and quickly identify protocol-eligible patients. Physicians can leverage these tools to identify potentially life-changing (or even life-saving) trials in the patient’s geographic area that offer opportunities for advanced care. Of course, this needs to be done in an HIPAA-compliant way, with patients opting in to have their medical records analyzed and matched with specific studies in their area for which they may be eligible, including any related to patient race and ethnicity. Patient outreach coordinators can then work with their physicians to pre-quality patients and connect them with the trial sponsors or contract research organizations (CROs) that are enrolling patients.

Increasing access through bilingual initiatives

This targeted approach is of particular value to patients who are non-native English speakers and who may have difficulty understanding the direct-to-patient recruitment messages that often appear in television commercials or in Internet ads. My company has started taking steps to increase access and break down barriers for minority patients who are not fluent in English, starting with Spanish-speaking patients. Some initiatives that are increasing access for these patients include offering screening questionnaires in both English and Spanish and hiring bilingual patient outreach coordinators to work directly with native Spanish-speakers. Patients are then able to discuss potential trial opportunities in Spanish and have a bilingual coordinator assist them in the enrollment process.

Greater access for greater understanding

Greater diversity in clinical trials is critical not only as related to equal access but also for understanding the full impact of different therapies and for ensuring their safety and effectiveness for people of all racial backgrounds. The best ways to achieve this are to increase access and awareness by adopting innovative approaches to patient recruitment that center on the trusted physician-patient relationship and leveraging EHRs and analytics to identify qualified patients.

Photo: Peopleimages, Getty Images 

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