Global Disruption: Decentralising Clinical Trials for Diversity, Faster Results
Diversity is a growing concern in all aspects of modern life, but the ramifications of this disparity in health care can have life threatening consequences. According to data from the FDA, African Americans are only 5% of individuals included in clinical trials, despite being more than 13% of the total U.S. population. Addressing this race inequality is just one of the goals of Jeeva Informatics and its founder and CEO Dr. Harsha Rajasimha.
Focusing on industrializing the process of bringing new solutions to market faster makes Jeeva Informatics an ideal fit for JOTO PR Disruptors(TM). “The work Jeeva Informatics does will bring new medicines or vaccines to patients who need them FASTER,” Karla Jo Helms, CEO and Chief Evangelist for JoTo PR, says. “They can improve patient outcomes—a life-saving example of the disruptive approach needed in the market today.”
A bioinformatics and genomics services company, Jeeva Informatics is working to heal a broken system by improving patient recruitment for drug trials, increasing participation and retention rates among diverse patients who may not otherwise be invited to participate in new drug development trials, and by increasing access to innovative research opportunities. “There are currently no regulatory demands on patient diversity,” Rajasimha says. This leaves all minorities underrepresented in clinical trials—from women to members of the LGBTQ+ community, to people living in rural or hard-to-reach geographies. “Any benefits these minority groups derive from medications after marketing approvals by the FDA are subject to the results of testing them on a homogeneous group during clinical trials.”
One of the problems that clinical trials face—and the main reason why they need to be decentralized—is that for the most part, potential participants live far from the test site, they have conflicts with the time, and face difficulties finding childcare while they are away, among other reasons. This is why participants in as much as 80 to 90% of the cases tend to be white, affluent males. The number of women who participate has been estimated at 25%. This data then leads to the question: how can women and minorities trust the effects of medication if clinical trials do not contain members like them?
“Not having decentralized trials leaves too many people without health care solutions to meet their unique challenges. Enrolling diverse populations in clinical trials is necessary for proper evidence generation and to help ensure that a therapy is effective for and trusted by everyone it is intended to help,” Helms says.