The Diversity Problem: Making Clinical Trials Work for Everyone

By Maxine Bookbinder

March 31, 2016 | Twenty-three years after the National Institutes of Health created the Revitalization Act to increase the number of women and minorities in medical research, these groups remain vastly underrepresented in clinical trials. But, after all these years, a cure may finally be prescribed.

Black Americans comprise 13.2% of the population but just 5% of clinical trial participants, according to Karen Brooks, Ph.D., Senior Director of Clinical Operations at Adare Pharmaceuticals. Hispanics are 16% of the population, but only 1% of trial participants. Meanwhile, 67% of Americans are white but represent 83% of clinical trial participants.

Black women under age 45 have the highest percentage of breast cancer of all women, including triple negative cancers which have poorer prognoses. Although they are diagnosed at a 10% lower rate than white women, black women are 41% more likely to die from it. Despite this, only about five percent of clinical participants are [black], according to Brooks. “We need to figure out how to cross these barriers. The welfare of the patient should take precedence. We should bring these trials to the patient.”

Karen_BrooksAccording to the NIH, a minority group is a “readily identifiable subset of the U.S. population that is distinguished by racial, ethnic, and/or cultural heritage.” Each group has subgroups delineated by geographic and national origins and/or cultural differences. Minority groups include American Indian or Alaskan Native, Asian or Pacific Islander, Black, not of Hispanic Origin, and Hispanic.

Based on U.S. Census Bureau statistics, a majority of American children will be non-white by 2020 and by 2060, the American non-white population will reach 56%.

According to the FDA, increased clinical trial diversity could help researchers improve treatments for diseases that disproportionately affect individual populations and ensure the safety and effectiveness of new therapies for everyone. For example, approximately 25% more blacks than whites die from chronic heart disease but are under-represented in clinical trials. Women have been under-represented in some cardiovascular trials.

Trust Issues

But if a person has had negative encounters with authority figures, he or she may have misgivings about entering a trial based on a 20 minute conversation with a doctor. “Many minorities are constantly fighting barriers,” says Brooks. “They don’t think doctors have the patient’s best interest [in mind].” She says that without experience or physician information, a patient’s only frame of reference may be the fictional negativity they see on Law and Order or Empire. “They say, ‘Oh, I don’t want to be a guinea pig.’ They don’t know about informed consent, IRBs, ethics boards, or that they can withdraw at any time. They don’t realize that participation in clinical trials could offer benefits as well as risks.”

Trust – or the lack of it – is one barrier to increased participation. Pharma, says Brooks, has maintained a transactional-only relationship with minority communities and professional organizations. For example, many pharmaceutical companies contact groups such as the National Black Nurses Association, the National Association of Hispanic Nurses, churches or other community organizations only when necessary. “Someone told me, ‘They come to us only when they need us.’ They should be a part of the support system throughout the year, not just when needed.” Brooks recalls a pharmaceutical company that gave an AED defibrillator to a large Chicago church. Such acts, she says, increase trust and build proverbial bridges, thus overcoming racial barriers, cultural gaps, and suspicion.

The Provider Problem

Another reason for low enrollment is access to trials. Some doctors don’t make referrals for fear of losing patients. In addition, sponsors repeatedly run trials in large city hospitals, not small community hospitals that can’t support clinical trials, but where many minority patients seek treatment. Some patients will hesitate to enroll if they must travel long distances, lack insurance, or if compensation fails to cover child care and missed work. Brooks says these issues could be remedied if sponsors budgeted for parking and overnight stays, and if all insurance companies covered trials. In addition, pharma and the medical community could increase consumer knowledge through media campaigns and education.

Doctors often don’t have time to peruse the thousands of clinical trials and their specific requirements, which are sometimes so stringent—particularly in cancer trials—that patients who would benefit don’t qualify. “Doctors just don’t have time to go through all these trials in a 30 minute consult,” says Brooks. Instead, she says, a one-panel database in which a doctor could submit the patient’s data and which would then display eligible trials would increase referrals.

The average minority Joe who could benefit from trial inclusion faces cultural and environmental obstacles. Doctors don’t invite these patients, making assumptions based on institutional bias, that all minorities lack funds, compliance, transportation, and a desire to follow through. “[Many] are just as willing to participate,” says Brooks, “but are never asked.”

Studies show that minority patients are more comfortable self-reporting to minority, rather than non-minority, doctors. According to JAMA Internal Medicine (“Minority Physicians’ Role in the Care of Underserved Patients”, doi:10.1001/jamainternmed.2013.12756), in a 2010 study of 7,070 adults, non-white physicians treated 53.5% of minority and 70.4% of non-English speaking patients.

However, in 2010, out of 13,000 oncologists, only 3% were black and 7.5% Hispanic, according to the American Association of Clinical Oncology. By 2030, cancer rates are projected to increase by 45%, with the largest increase in older adults and minorities (Smith et al, “Future of Cancer Incidence in the United States,” JCO, 2009, doi: 10.1200/JCO.2008.20.8983).

Therefore, as Americans age and minorities become the majority, the U.S. will need more physicians from diverse backgrounds to fill the healthcare void of underserved populations.

Filling the Gap

Recruiting physicians, particularly oncologists, to care for minority communities will increase cultural competency, community comfort, and patient well-being.

“Imagine you are sick and anxious, English is not your first language, and you are traumatized. We must put ourselves in the other person’s shoes,” says Janice Chavers, Director, Diversity & HR Communications at Eli Lilly and Company.

Eli Lilly and The Center for Drug Development and Clinical Trials at Roswell Park Cancer Institute in Buffalo, New York developed a program three years ago to train minority doctors to become principle investigators.

The partnership created an annual 3-day workshop, “Reducing Cancer Disparities Through the Training of Diverse Workforce,” which trains minority oncologists in research and trial design for underserved populations to become principal investigators and, subsequently, to reduce cancer health inequalities among minorities. The program provides continued mentorship with workshop faculty for participating physicians and, according to Vun-Sin Lim, M.D., research associate at Roswell Park, enhances collaboration among participants, who can pass their training on to other physicians. “The result,” says Lim, “is better patient care.”

In February, Eli Lilly and The National Center for Bioethics in Research and Health Care (National Bioethics Center) at Tuskegee University announced a collaboration to determine, through research, education, and community engagement, how to increase black participation in clinical studies. “This is the perfect partner to work with,” says Chavers. “This will be a detailed study approaching the problem from multiple angles.”

The National Minority Quality Forum (NMQF) is also attempting to fill the diversity discrepancy. “We have billions of patient records to help us understand who and where populations are that have diseases, and rare diseases that hit Americans,” says Gary Puckrein, Ph.D., president and chief executive officer. A research and educational organization committed to improving the healthcare of high-risk racial and ethnic populations, this nonprofit organization integrates data and expert initiatives to eliminate health disparities.

NMQF collected data from 2000-2014 on how many people at specific zip codes had particular diseases, such as diabetes, HIV, and hepatitis C, and who treated them; sponsors can use this data to help facilitate trial recruitment.

NMQF and the Pharmaceutical Research and Manufacturers of America (PhRMA) launched “I’m In,” a national education program designed to engage underrepresented populations and communicate the value of clinical trials. It also connects with prominent local figures and care providers to encourage minority patients to enroll.

Support is arriving from more traditional venues, as well. Before, investigators did not always know if certain populations suffered higher incidences of reported side effects. Now, updates on section A of the new MedWatch form breaks down participant reports demographically, giving more transparency to problematic trends.

In 2012, Section 907 of the Food and Drug Administration Safety and Innovation Act (FDASIA) directed the FDA to investigate how well specific subgroups are represented in clinical trials in applications for medical products and if subgroup safety and effectiveness data are available. It includes 29 action plans and a requirement to provide Congress with an action plan detailing, “recommendations for improving the completeness and quality of analyses of data on demographic subgroups in summaries of product safety and effectiveness data and in labeling; on the inclusion of such data, or the lack of availability of such data, in labeling; and on improving the public availability of such data to patients, health care professionals, and researchers.” 

However, all these improvements are just recommendations. “There is no mandate,” says Adare Pharmaceuticals’ Brooks. “Without a current mandate in regulations to increase minority participation in clinical trials, pharma companies are challenged with justifying the allocated resources to make significant changes.”


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