A Forgotten Majority: Patient Diversity In Clinical Trials

By Robert A. Beltran, M.D., president, Quality Health Care Management,
Sara Tolsky, M.B.A., president, Farma Consulting,
Owen Garrick, M.D., president & COO, Bridge Clinical Research

What is the future of medicine and healthcare now that Obamacare is the law of the land, especially now since the forgotten majority-vulnerable populations will be covered under the Patient Protection and Affordability Act?

No one can deny the essential role that clinical trials have played in the progress of medicine and healthcare. Clinical trials are as fundamental to medicine as baseball and apple pie are to America. The quality and outcomes of clinical trials continually contribute to excellent care delivered in the majority of our major medical centers throughout the United States.

Even though we recognize the importance of patient diversity in clinical trials, along with the racial/ ethnic differences in the causes and responses to the treatment of various diseases, recruitment of both physicians and patients in clinical trials remains a challenge. In 2001, Congress mandated that minorities should be included in government sponsored clinical trials to elicit relevant information, yet Hispanic participation rates still remain low, relative to the 50.5 million known Hispanics living in the U.S. (16.3% of the U.S. population). So why is the ethnic diversity of clinical trial participants so limited?

Today, typical patients entering a clinical trial are middle-class, affluent, well-educated Caucasians. This patient population is well-established in site databases and responds well to messages geared to the upper end of Maslow’s Hierarchy of Needs, such as self-actualization and altruism. These traditional recruitment methods are not aimed at lower socioeconomic groups, many of which are underserved medically, representing more than half (52%) of uninsured Americans in the U.S. who have no regular source of health insurance.

What About Hispanics And Latinos?

One focus group, held in 2011, explored why Hispanics and Latinos did not participate in clinical trials. While there were a number of misperceptions about participation in clinical trials (i.e. “I don’t have health insurance so I can’t participate” [35%]), the main reasons were lack of information and lack of (a) Hispanic physicians or (b) walk-in/emergency clinic physicians who recommended and referred patients to clinical research trials. Sixty-nine percent stated, “It’s important to have a Hispanic/Latino healthcare professional who understands the language and/or culture,” and 46% said they would be more likely to participate in trials if the information came from a Hispanic/Latino caregiver.

Research shows that a bottom-up, “a las calles” approach is more successful in recruiting these patients to clinical trials. This approach includes outreach programs, walk-in clinics, independent pharmacies, and social work departments that deal directly with patients. Additionally, messages used to promote participation in clinical trials must focus more on the benefits of participation such as “free” regular medical assessments, multifaceted diagnostic evaluations, free drug, and reimbursement commensurate with fair market value.

Patient management must also be more targeted towards patient satisfaction (i.e. “good customer service”) and deal with the practical realities of day-to-day living for those with little or no disposable income (e.g. arranging for transportation that does not require the patient to up front the cost and ensuring prompt payment for each medical visit).

We Need Support For Clinical Trials Diversity

We believe two critical supporters in the endeavor for clinical trials diversity are the policy makers and clinical researchers. If clinical researchers are to have more responsibility in supporting greater patient diversity in clinical trials, then our policy makers must provide resources that enable action and accountability for such diversity.

Exploring new ways to reach out to the less advantaged U.S. patient populations can be an adjunct to traditional recruitment methods and a way to enhance the new pending regulations for increasing care for the underserved, forgotten majority.

The “new” law of the land now provides a foundation for this necessary change for greater diversity in clinical trials to become a reality.