Differences in genetics, physiology, race, ethnicity, age, and sex, as well as numerous other extrinsic factors, are known to affect individual response and sensitivity to treatment drugs. However, to this day men, and mostly Caucasian men, remain the predominant group in which new drugs are trialled.
Testing experimental drugs in a demographically homogenous group makes bringing new drugs to market considerably easier and cheaper, as there will be less variation in treatment response during trials.
However, by designing studies that only analyse a narrow patient cohort, those trials will be unrepresentative of a large part of the patient population. According to a 2018 ProPublica report, for instance, African Americans who represent over 13% of the US population, only made up 5% of all oncology studies, even for cancer types which disproportionately affect them.
A lack of diversity in clinical trials means that our medical understanding will be skewed towards, and only fully applicable to, one, albeit majority, subset of the population. The medical findings that we have established are, therefore, not generalisable. This is particularly salient in cardiovascular health where African Americans, Hispanics and other minority groups have benefited markedly less from advances in the standard of care in recent years. By designing trials with more inclusive enrolment procedures that encourage minority groups to participate we can enhance our medical understanding of race and ethnic-based variation in response and hopefully, reduce outcome disparities.
Barriers to minority participation
Luther at al., 2018, used a multistep approach, that involved a literature review, to identify the following five factors as being critical barriers to minority group participation in U.S. clinical trials:
- Mistrust and fear of being a “guinea pig”
- Lack of comfort with the clinical trial process
- Lack of information about clinical trials
- Time and resource constraints associated with participation
- Lack of awareness about the existence and importance of trials
How can we create sustainable solutions?
Distrust of experimental medicine still smoulders in some minority communities as a result of historical injustices perpetrated against them by researchers. Famous past scandals such as the Tuskegee Syphilis Study, where researchers, without consent, withheld the treatment from black patients to study the natural progression of the disease. As an even more abhorrent example, thousands of black women were sterilised during the 1970s without full knowledge of the procedure or its ramifications.
To address the lack of trust, and overt mistrust, of the research community and system that exists in some minority groups, strong communication must be fostered. This may be through trusted community channels including partnerships with care providers, community leaders, religious leaders etc, in a culturally appropriate manner. The Luther et al. paper also stressed the significance of family and friends in influencing patient participation. Therefore, to increase the comfort of participants it’s important to include family members in decision-making conversations.
On a similar vein, effective communication with participants to demonstrate the value of clinical trials and the importance of the research process can drive participation. Notably, the patient’s GP is a key influencer during the contemplation stages of decision making.
This same study affirmed the significance of logistical and financial constraints that clinical trials can put on minority groups. By involving key stakeholders including patients and investigators, the study found that relatively minor interventions could increase the likelihood of participation. Suggestions included the sponsors providing private transport, flexible consultation hours, appropriate compensation and providing technologies where participants don’t already have access, for example smartphones needed to support health monitoring apps.
Existing initiatives to increase diversity in clinical trials
In response to the ProPublica report that found black and Native Americans to be significantly underrepresented in U.S. clinical research, The National Black Church Initiative wrote an open letter to Scott Gottlieb, then-Commissioner, advocating that the FDA mandate diversity: “Simply put, the pharmaceutical community is not going to improve minority participation in clinical trials until the FDA compels them to do so via regulations.”
Just over a year ago, the U.S. FDA issued a draft guidance whitepaper on how to increase the diversity of clinical trials, through the promotion of broader enrolment practices. In the report, the Agency encourages clinical trial sponsors to broaden eligibility criteria and to consider logistical and financial resources during trial design, that could make trials more accessible to underrepresented groups.
In January of this year Stand Up To Cancer, announced a first-of-its-kind health equity initiative aimed at reducing the racial and health inequalities in cancer research and increasing minority representation in trials. The initiative will fund research projects that demonstrate recruitment and retention of ethnically diverse participant groups. Additionally, the programme will collaborate with Black Women’s Health Imperative (BWHI) and other advocacy groups, to “empower black women, through education, to effectively engage with researchers and clinicians, and to increase participation of black women in cancer-focused clinical trials.”
Is now the time?
With the gaping divide in health disparities, brought to light by the vastly disproportionate toll that COVID-19 has taken on black and minority populations in America, will industry and academia finally affect more diverse research? Like the demands for racial equality, are patients done waiting patiently?
Image source: Training Journal