The US pharmaceutical sector has a track record of underserving diverse communities and often researches and develops drugs and devices without actively involving different patient populations. Simply put, participation in clinical trials is not representative of the broader population. Black Americans make up 13.4 percent of the population but make up only 5 percent of the study participants, and while 18.1 percent of the US population are Latinos, as a group they make up less than 1 percent of the study participants. As the pharmaceutical industry battled research into COVID-19 vaccines, leading developers were rightly held accountable for failing to enroll nationwide representative patient populations in clinical trials. However, this phenomenon is certainly not new. We believe it is time for the Food and Drug Administration (FDA) to take more initiative and encourage drug developers to prioritize diversity in clinical trials.
The research is clear: women and patients with color face significant barriers when participating in clinical research. There are far fewer drug trials in hospitals and clinics that mainly care for women and people of color. Pharmaceutical companies often run studies where convenience is more important to their business than patient participation. In many studies, for example, trial visits are planned during working hours or the candidates’ travel and transport costs are not taken into account. In addition, historical abuses inflicted on people of color across the medical field – from the forced sterilization of the indigenous women of America to the Tuskegee’s terrible syphilis experiment – have created greater distrust within the broader healthcare system. Not only has this mistreatment resulted in less meaningful data on drugs and devices in development, it has also directly resulted in serious, long-standing health inequalities for people of color.
To draw patients over the profit
When it comes to clinical trial design, our pharmaceutical sector needs to start putting patients above profits. For example, non-profit pharmaceutical organizations such as Medicines360, which one of us (AE) carries with us, had the leeway to prioritize other impact metrics beyond sales and efficiency, namely how the industry can best improve broad access to essential drugs. With no fiduciary responsibility to shareholders or a mandate to maximize profits, Medicines360 has made investments that truly address inequalities in women’s health, conducting clinical trials with participants addressing the diverse patient populations found in community health centers and Title X clinics that Medicines360 prioritized, better reflecting, better reflecting. It is time for for-profit companies hit the moment to deliver color for women and patients. To do this, they have a moral and fiduciary obligation.
The FDA also plays a vital role in addressing this inequality. In addition to its recently published guidance on the subject, the FDA should explore new ways to encourage study sponsors to include more diverse study participants. The Agency should consider issuing a clarifying guide that encourages prospective study sponsors to use disproportionate publicly funded clinics and hospitals as study centers to accommodate more representative study populations. The FDA should also provide guidance on how medical device manufacturers can include more representative populations in clinical trials and thereby achieve better scientific results.
In addition to providing guidance, the FDA should solicit public opinion from organizations that have successfully conducted a variety of research (especially for women’s health products, which are often under-researched) and reporting on best practice. Finally, there is an urgent need for a “whole-of-government approach” in which the Department of Health and Welfare could form a cross-sectoral working group made up of the Centers for Medicare and Medicaid Services, Administration for Children and Families, Centers for Control and Monitoring Disease Prevention, together with nongovernmental stakeholders in a collaborative effort to develop policies and programs that increase the diversity of the clinical study population.
Beyond the first step
Many years ago the great Senator Ted Kennedy worked with one of us (HW) along with staff and others to pass the National Institutes of Health Revitalization Act of 1993, which mandated that women and people of color should be included in clinical research studies. This guideline was an important first step in diversifying clinical study populations, but the historical abuse of these patients leaves gaps and it is up to all of us to fix this broken system. Fortunately, there are already important steps you can take to address this issue. The FDA needs to step up oversight and drug manufacturers need to focus on health equity. Together we can increase and improve health outcomes for everyone.
Editor’s note
Henry Waxman is an advisor to Medicines360, the non-profit pharmaceutical organization whose work is described above.
source https://www.bisayanews.com/2021/09/03/pharma-must-diversify-its-research-heres-how-regulators-can-make-sure-it-happens/
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