The concept is simple and sensible: if a new medical treatment or medication is meant to be used on all members of the population in need of it, it should be tested on all genders and ethnicities.
Diversity in medical research has been a point of agreement and discussion for decades, with ongoing efforts to reach everyone, but, as experts sadly agree: We aren’t there yet.
It’s crucial to represent all races and ethnicities, since symptoms and incidence of heart disease, cancer and diabetes aren’t the same across the board. Diverse groups must participate in research, or there’s no way to know if a treatment will work in all populations or if some will have failures and serious side effects.
How bad is the situation?
- Less than 10% of clinical trial enrollees are minorities, according to some estimates.
- Black and Hispanic participants are consistently underrepresented in cancer drug trials, especially compared with how often they get the specific cancers under study, an analysis that reviewed the years July 2008 to June 2018 found. Only 3.1% of participants were black; just 6.1% Hispanic.
- Older patients and women are often underrepresented in heart failure trials, for instance, an analysis looking at more than 215,000 patients enrolled in studies from 2001-2016 found. Nonwhite participants increased from 22% to 30%; in some studies women made up 62% of participants, but in others only 29%.
The lack of diversity affects research on medications as well as treatments for cancer, heart disease, diabetes and other ailments. “It’s really important to draw attention to the problems,” says Karen Winkfield, MD, PhD, director of the Office of Cancer Health Equity at Wake Forest Baptist Health in Winston-Salem, NC, and a member of the Stand Up To Cancer (SU2C) committee for healthy equity in cancer clinical trials.
Signs of progress
Progress is being made. Among the advances:
- One of the first steps was the passage, in 1993, of the National Institutes of Health Revitalization Act, which required the NIH to include more women and people of color in research.
- The FDA Safety and Innovation Act (FDASIA), signed into law July 9, 2012, covers details such as promoting innovation to speed access to effective products. However, its section 907 also directed the FDA to investigate how well subgroups (sex, age, race, ethnicity) are included in clinical trials and if data on safety and effectiveness in the different subgroups is submitted.
- Stand Up To Cancer, (SU2C), a nonprofit that raises funds to speed the pace of research, just announced a stringent new requirement: all researchers looking for funds must include and address issues in their proposals related to recruiting and retaining patients from ethnic groups. The researchers ”are going to be forced to go where they haven’t gone before,” says Dr. Winkfield.
Among the barriers to people enrolling in research, Dr. Winkfield says, are lack of access. “We know for the most part clinical trials happen at large institutions, so those not near those may not have accessibility.” Mistrust of the medical system keeps some minorities from participating, experts know. And minorities may be less likely to comply with taking medications, sometimes due to costs.
Until more progress comes, here is what to know about clinical trials and getting assistance, if needed, with pharmaceutical costs.
- Minorities in Clinical Trials Fact Sheet, from the FDA, gives information about participation and the importance of minorities signing up.
- Prescription assistance programs are also offering help. See https://catalyst.phrma.org/the-partnership-for-prescripton-assistance-a-history-of-caring and https://www.medicare.gov/pharmaceutical-assistance-program.