Global Disruption: Decentralizing Clinical Trials for Diversity, Faster Results

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Credit: University of Cape Town News

TAMPA BAY, Fla., Oct. 19, 2021 /PRNewswire-PRWeb/ — 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.(1) 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.(2) The number of women who participate has been estimated at 25%.(3) 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.

About JOTO PR Disruptors(TM):After doing marketing research on a cross-section majority of 5,000 CEOs of fast-growth trajectory companies and finding out exactly how they used PR, how they measure it, and how they wanted the PR industry to be different, PR veteran and innovator Karla Jo Helms created JoTo PR(TM) and established its entire business model on those research findings. Astute in recognizing industry changes since its launch in 2009, JoTo PR’s team utilizes newly established patterns to create timely Anti-PR(TM) campaigns comprising both traditional and the latest proven media methods. This unique skill enables them to continue to increase the market share and improve return on investment (ROI) for their clients, year after year—beating usual industry standards. Based in Tampa Bay, Florida, JoTo PR is an established international public relations agency. Today, all processes of JoTo are streamlined Anti-PR services that have become the hallmark of the JoTo PR name. For more information, visit JoTo PR online at http://www.jotopr.com.

About Jeeva InformaticsJeeva Informatics Solutions, Inc., based out of Tysons Corner, VA, partners with Biopharmaceutical sponsors, CROs, and clinical researchers to accelerate clinical studies. The Jeeva TRIALMAGNET(TM) package of the patent pending Jeeva eClinical Cloud platform achieves remote patient recruitment goals by as much as three times faster. Jeeva’s flexible bring your own device (BYOD) SaaS solution works on any browser-enabled mobile device and saves more than 70% time by minimizing logistical burden on study teams and patients. Modular software design allows a rapid study configuration with the features and workflows that fit the specific trial protocol whether short-term or long-term, cross-sectional or longitudinal, interventional or observational studies, clinical phase or post-market, hybrid or fully remote. To learn more, visit jeevatrials.com.

1.    “Why We Need To Improve Patient Diversity Amongst Clinical Trial Participants,” MD Group, mdgroup.com/blog/why-we-need-to-improve-diversity-amongst-clinical-trial-participants/

2.    “Clinical Trials Have Far Too Little Racial and Ethnic Diversity,” Scientific American, September I, 2018, scientificamerican.com/article/clinical-trials-have-far-too-little-racial-and-ethnic-diversity/

3.    Brazil, Rachel; “Why we need to talk about sex and clinical trials”; The Pharmaceutical Journal; May 28, 2020; pharmaceutical-journal.com/article/feature/why-we-need-to-talk-about-sex-and-clinical-trials