Story at a glance
- Currently, there are no regulatory demands on patient diversity for government approval of clinical trials.
- As a result of both historic bias within the medical community and a lack of access, minorities are often underrepresented in clinical trials.
- Many of these treatments are targeting conditions that disproportionately affect Black patients, Indigenous patients and other patients of color.
Black, Indigenous and other Americans of color are being left out of vital medical developments, including those targeting diseases and conditions that disproportionately plague nonwhite communities.
“How can a drug aimed at the general public be trusted if its effect on other races and ethnicities is unknown?” asked Harsha Rajasimha, founder and CEO of Jeeva Informatics, in a press release. “Both for patients themselves and for public confidence in the drug development process, we need to improve diversity in clinical trials.”
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The race to develop a coronavirus vaccine last year offered a diversity of approaches from across the world toward inoculation, but the medical community in the United States has a long history of bias against Black and Indigenous communities. A well-founded mistrust in scientific testing proved a major obstacle to diversifying trials for a COVID-19 vaccine over the last year.
"We need to get a diverse representation of the population in the clinical trials," said National Institute of Allergy and Infectious Diseases Director Anthony Fauci at the time. "So when they are proven to be safe and effective, we can say they are safe and effective in everyone, not only in whites."
After Moderna vaccine trials were delayed by insufficient minority participants in October, the company ultimately enrolled more than 11,000 participants from communities of color out of 30,000 total volunteers. These communities were disproportionately affected by the coronavirus pandemic both economically and physically, with Black and Hispanic Americans dying at higher rates than other populations.
While trust can be built, however, access remains a major problem for many Americans who are not even able to find and afford basic health care. But the coronavirus pandemic also provided an opportunity to test and expand the possibilities afforded by telehealth. Jeeva’s eClinical Cloud would allow for participation in clinical trials on any browser-enabled mobile device.
“When built into a clinical trial protocol, it can significantly broaden the potential diversity of the study without overburdening its cost,” said Rajasimha in the release. “Perhaps as well, regulatory agencies such as the FDA could take a more active role in broadening the diversity of participants in clinical trials.”
Currently, there are no regulatory demands on patient diversity for government approval of clinical trials and the consequences can be serious. In addition to racial and ethnic minorities, women, members of the LGBT community and people living in rural or hard-to-reach geographies are underrepresented in many clinical trials. Earlier this year, the Johnson & Johnson vaccine was temporarily suspended after six women developed a rare condition leading to blood clots.
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