As an industry, our primary goal is to bring safe and effective medications to the individuals who need it the most. The United States Food and Drug Administration (FDA) is tasked to safeguard public health – ensuring Americans are able to make health care decisions based on accurate, research-based information. By and large, each entity is fulfilling its purpose, but are we dropping the ball when it comes to ensuring that approved medications are meeting the needs of our diverse population? I think so.
Case in point– did you know that one out of five people diagnosed with multiple myeloma is African-American? In fact, they are more than twice as likely as white Americans to be diagnosed with this type of cancer. Yet in the 2015 FDA approval of Ninlaro for the treatment of multiple myeloma, African-Americans made up only 1.8% of the trial participants. Unfortunately, this was not a singular incident– similar disparities are shown in other clinical trials as well. Let’s use prostate cancer as another example. African-Americans are the leading ethnic group diagnosed with prostate cancer. But, from 2009 to 2015, African-Americans only represented 3% of the participants in prostate cancer clinical trials. Why haven’t we integrated these important groups of patients into our clinical trials more effectively?
Barriers to Increased Diversity
There are a number of barriers that have hindered equal representation in clinical trials among not only different racial groups, but also between gender, class, and age. A huge hindrance that minority groups face is access to adequate health care, both in proximity and affordability. A 2015 study found that patients with an annual household income below $50,000 had 32 percent lower odds of participating in a trial than patients with income above that threshold.
Clinical trials often take place in larger research and academic facilities located in major hubs like Boston, New York, and Atlanta, yet many patients needing care live in rural areas. The financial burden and time commitment necessary to travel regularly to doctors’ visits in these cities often prove to be too expensive for many patients. Some clinical trials require participants to visit the doctor’s office weekly or mandate a number of assessments in order for the patient to be compliant with the protocol. Plus, with each doctor’s visit and assessment being accompanied by an insurance copay that is not covered by the clinical research company, the cost to participate already diminishes a great deal of the population pool.
Another barrier to diverse clinical trials is the implementation of strict exclusion criteria. Sponsor companies prefer to evaluate patients with fewer preexisting conditions for ease of evaluation, as sicker patients confound analysis. Having a restrictive exclusion criterion can prevent clinical trials from having a well-represented consortium, as many of these comorbidities are linked to specific ethnic and racial groups.
An additional barrier to trial participation is the lack of trust within minority groups, based on previous historical misconduct of clinical research. There are numerous examples of clinical misconduct, such as the “Tuskegee Study of Untreated Syphilis in the Negro Male” where African-American men were left untreated for syphilis and observed to watch the progression of the disease for over 40 years. Another example is the CDC and Kaiser Permanente co-sponsored measles trial comprised of 1,500 African-American and Hispanic infants in the Los Angeles area. During the study, parents were not informed that an experimental vaccine would be administered to their babies and naturally, the mistrust of clinical trials involvement in ethnic communities continued to fester.
What Can Be Done
It is apparent that our industry and its regulators know that more could be done to improve the inclusion of diverse patients in our clinical trials. Both the NIH and FDA have either mandated or incentivized the inclusion of women and underserved racial and ethnic groups within clinical trials—this is a wonderful and significant step in the right direction. The NIH Revitalization Act of 1993 and its amendment in 2017 dictate that all NIH-funded clinical research will be inclusive of diverse racial and ethnic groups. This will help ensure that research findings can be representative of the entire population and not just a sub-population. The FDA has made additional strides with its more recent draft guidance in June 2019. Though not a mandate, the guidance does spell out measures in which the clinical research community can begin to think and develop clinical trials with diversity and inclusion in mind.
Whereas print and digital media act as great advertisements for joining a clinical trial, a doctor’s recommendation proves far more powerful. Patients create trusting relationships with their doctors. To increase transparency and build trust in clinical trial participation, increased efforts can be made to recruit practitioners of color to participate and endorse clinical trials that will benefit patients of underserved groups. The NIH has made strides in this regard through increased funding provided to minority researchers through initiatives such as the Diversity Supplements Program. The program is designed to recruit and train scientists from underrepresented groups within the biomedical research workforce.
To address accessibility concerns, practitioners and pharmaceutical companies can offer new and innovative ways to conduct clinical trials to ease the burden on patients. Advancements such as the use of virtual sites like eConsent allow patients to self-report from the comforts of their homes as opposed to having to frequent doctors’ offices.
While implementing meaningful change to increase diversity in clinical trials may not be easy, all patients deserve to have access to the cutting-edge therapies that exist today. To best serve the needs of those who need treatment most, clinical trial participants must reflect the diversity of the disease population. To date, there has been a great deal of research aimed at identifying the disparities in ethnic representation in clinical trials. To move to an epoch of minority inclusion and representation within medical research, deliberate efforts must be made not only to identify barriers to minority involvement but also to recognize and create new initiatives to foster minority participation.
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