Create All-Inclusive Clinical Trials

Americans are living longer, healthier lives due to technological advances, preventive medicine and access to healthcare. Yet some health statistics continue to show marked differences in life expectancy, mortality, incidence of disease, and causes of death across racial and ethnic groups. Well-documented health disparities exist among racial and ethnic populations, even if insured.

Compounding the problem of healthcare disparities: An explosion of racially diverse groups in America in the last 20 years. Before the middle of this century, one out of every two Americans will be a person of color or a person of color who speaks Spanish. What we now call “minority” health will become the nation’s health.

Disparities in health and healthcare aren’t new, but eliminating disparities is garnering renewed urgency with a growing constituency and customer base, including drug manufacturers, health plan purchasers, payers and providers of care. One significant contributor to health disparities is the absence of research to clearly identify the sources of differences in outcomes in racially diverse groups and to distinguish among biological, environmental or social causes of disease differences.

Disease Differences in “Minority” Populations

Evaluation of disease differences in racial and ethnic populations is essential to understand the mechanisms of pathophysiology, and to optimally target therapeutic and drug responses. Research has shown that differences in biology and genetics influence the efficacy of treatment. Clinical research, the foundation for the practice of evidence-based medicine, determines whether new drugs and treatments are safe and effective.

Clinical research demands the collection of data on racial and ethnic populations, an assessment of differences in disease patterns and responses to medicines in development. It stands to reason that the more diverse the trial participants, the more confidence physicians have in study results and the benefits of the medicine, once approved by the FDA.

Age and gender have been consistent demographic components in clinical research; however, race and ethnicity as inclusion factors for study participants are far too often overlooked by researchers. The safety and efficacy of new medicines and vaccines depend on their evaluation in the populations that will be using them.

Recruiting Underrepresented Groups

Researchers have struggled to improve participation rates among underrepresented populations. This challenge confronts the healthcare industry focused on personalized medicine, patient-centered care and improved outcomes among diverse groups that are disproportionately affected by chronic disease. Researchers typically extrapolate trial data from white study participants and apply them to people of color. This could be dangerous now that scientific evidence indicates that certain drugs differently affect various ethnic groups. This could affect adherence, treatment outcomes and even patient survival.

Compared to whites, African Americans are on average twice as likely, and Hispanic Americans are 1.7 times more likely, to develop type 2 diabetes.1 Yet, these groups are often underrepresented in studies of promising new treatments. African American men are twice as likely to die from prostate cancer as their white counterparts, but represent only 4% of prostate cancer clinical trial participants.2 Cancer is the leading cause of death for the Asian-American population, yet Asian Americans represent less than 3% of clinical trial participants.3

These are the critical indicators that pharma continues to design clinical trials wholly unrepresentative of the wider population significantly impacted by debilitating and chronic conditions.

It has been more than 20 years since the first government regulations and recommendations sought to ensure that racially diverse populations in clinical trials appropriately reflect the composition of the U.S. population. NIH Revitalization Act of 1993 requires that federally funded trials include diverse populations in numbers adequate to allow for valid analyses of differences in intervention effect. The FDA Modernization Act of 1997 requires standardization of data collection on racial and ethnic groups.

Despite these efforts, the continuing lack of racial diversity is a persistent problem. Blacks’ participation in trials steadily declined from 12% in 1995 to 6% in 1999.4 While African Americans represent 14% of the U.S. population, they now comprise just 5% of clinical trial participants. Hispanics now account for 16% of the total population but just 1% in trials.  The numbers are even worse when you look at clinical trials aimed at diseases disproportionately affecting communities of color—cardiovascular disease, stroke, diabetes, HIV/AIDS, cancer, Alzheimer’s disease and respiratory diseases, among other chronic health conditions.

Mistrust Creates Recruitment Reluctance

Perceived or real barriers to clinical trial participation of diverse groups abound. Fundamental mistrust, costs, transportation and cultural differences prevent us from advancing efforts to decrease disparity. But history hasn’t helped. Black men with syphilis were deliberately left untreated for decades in the infamous Tuskegee Experiment.  From 1932 to 1972, the U.S. Public Health Service allowed 399 Black men with syphilis to go without the benefit of penicillin. The Tuskegee Study has been described as the longest-running experiment on human beings in medical history. By the end of the study, 128 men had died from syphilis and its complications. At least 40 of their wives were infected and 19 of their children were born with syphilis.

Although it has been 83 years since the Tuskegee Study and 40 years since it was halted, it has become America’s metaphor for racism in medical research and misconduct in clinical research. It explains in part why African Americans remain reluctant to participate in clinical research, why they are hesitant to take their medications when they do finally see doctors, why they do so late, and why they suffer disproportionately from many diseases for which there are cures or improved quality of life.

Between 1945 and 1956, approximately 1,500 Guatemalan soldiers, mental health patients, prisoners and sex workers were deliberately infected with syphilis and gonorrhea so that the U.S. government could learn about the effectiveness of penicillin. Some were infected through injections into the spine, others through sex with commercial sex workers who had been infected by U.S. government public health doctors. Academic institutions and government agencies in the U.S. were aware of the study—it was funded by the NIH—but study participants did not give consent. Some were treated with antibiotics, but at least one died from the infection.5

New Approaches Required to Reach Groups

Clinical trials are the gateway to introducing new, safe and effective drugs. The research community must address and resolve why progress has not been made to successfully include and retain the numbers needed to qualify clinical trials as diverse. Reaching underrepresented populations requires new skills, new recruitment strategies, new culturally appropriate recruitment tools, and new competencies on the part of sponsors, clinical trial investigators and site teams and those who provide recruitment services.

Enlightened trial sponsors must strive to build bridges with new patients and caregivers of color. It demands a departure from business-as-usual to improve culturally tailored processes and outreach efforts that focus on high-touch connections with the target groups and their trusted community gatekeepers. It demands a focused, strategic effort.

Luckily, the tools exist to make this happen.

Ethnographic market research can geo-map potential participants and determine diverse patients’ and their families’ attitudes toward clinical research. Conducting focus groups, distributing questionnaires and community surveys before designing outreach strategies will reveal cultural and social patterns, knowledge and awareness. Community-based qualitative research will inform communication strategies and the development of educational tools necessary to motivate participation.

Utilizing direct to patient media, digital, TV and advocacy groups is still best practice, but these can all be leveraged differently to connect with specific demographic groups. Further, it is critical to identify, recruit and train investigators of color and members of site teams who reflect and are trusted by the target diverse groups.

Demonstrating Cultural Competency

Clinical site teams need to understand that trust deficit issues exist because of contemporary and historic experiences. Ongoing cultural competency and cross-cultural education of investigators and site teams will ensure a positive trial experience and successful recruitment and retention of participants.

Trial sponsors have much to consider in increasing the diversity of clinical trial enrollment. While more pharmaceutical companies are tailoring their materials to superficially appear ethnically correct, far too few are connecting with target populations in the community and far too many companies are still using traditional, one-size-fits-all recruitment strategies and tactics that do not resonate culturally with diverse patients, their families and their communities.

Cultural competency means more than putting ethnic faces on printed materials or language translations. This diversity gap can lead to sub-optimal development of new medicines and can further exacerbate health disparities in outcomes among racial and cultural groups.

The barriers to participation of diverse participants in clinical trials are formidable, but surmountable. It is clear that there is much still to be done to increase the participation of underrepresented communities of color in clinical trials. The pressure from the NIH and the FDA will only continue, especially in light of the growing diverse populations in the U.S. Diversity in clinical research is good medicine. It’s good science to ensure the delivery of quality, safe, effective patient-centered care in an increasingly multicultural society.

References:

1. www.diabetes.org/diabetes-basics/statistics.

2. www.cancer.gov/about-nci/organization/crchd/cancer-health-disparities-fact-sheet.

3. http://www.fda.gov/RegulatoryInformation/Guidances/ucm126340.htm; clinicaltrials.gov; www.cdc.gov/nchs/data/factsheets/factsheet_disparities.pdf.

4. Center for Drug Evaluation and Research

5. http://www.britannica.com/event/Guatemala-syphilis-experiment.

  • Shelia Thorne

    Sheila Thorne is President & CEO of Multicultural Healthcare Marketing Group, LLC. A multicultural healthcare marketing expert and cross-cultural educator, Sheila has spent more than two decades designing and implementing health programs for diverse populations. She has worked on multicultural programs for the pharmaceutical, biotech and medical device industry throughout North America, Latin America and Western Europe.

    • Ken Shore

      Ken Shore is EVP of Continuum Clinical, a part of Blue Chip Worldwide. Ken leads Continuum Clinical’s global product development and innovation activities, responsible for identifying new business opportunities and markets, advancing new product or service designs and marketing. He previously held a similar role with Blue Chip Patient Recruitment, a leading patient recruitment and retention firm.

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