Distrust, Fear Hamper COVID Vaccinations, Clinical Trial Diversity

TYSONS CORNER, Va., Oct. 12, 2021 /PRNewswire-PRWeb/ -- As of late September, 77% of the total adult population of the U.S. had received at least one dose of a COVID-19 vaccine. Black and Hispanic people, however, remain less likely than whites to have received a vaccine, leaving them at increased risk of infection, particularly as the novel variant spreads.(1) Some of this hesitance to vaccination, notes Dr. Harsha Rajasimha, founder and CEO of Jeeva Informatics, is rooted in long-lost trust. "We see it in clinical trials as well," he says. "Black and brown people need the medicines and therapies being developed but are less inclined to trust the professionals who develop them." This is unfortunate.

This, he observes, is not entirely an American problem. Researchers in the UK studied 400 reports from around the world and found that fear about testing new treatments was the most common reason given by all patients for not wanting to participate. Black and ethnic minority patients, however, also frequently cited mistrust of research and medical professionals as a reason for non-participation.(2)

In the U.S., Dr. Rajasimha notes, there is ample historical background for this unease.

• In 1945, a black hospital patient in Oak Ridge, Tenn. was injected, without his knowledge, with plutonium by doctors who were, also without the patient's knowledge, in the employ of the then-new U.S. Atomic Energy Commission.(3)
• In the 1950s, Enovid, the first successful birth control pill, was initially tested on poor women in Puerto Rico, three of whom died. The women were not told they were participating in a trial or advised of the risks they faced.(4)
• Twenty years earlier, in 1932, at the Tuskegee Institute in Alabama, 400 black men infected with syphilis were, without their knowledge, left untreated so as to study the full progression of the disease. The study was finally shut down in 1972.(5)

Candor and trust
To help overcome the lingering effects of these long-ago but well-remembered occurrences, says Dr. Rajasimha, it is necessary to address patients' fears with real facts and real data. Prospective clinical trial participants need to understand as clearly as possible what they are consenting to, what the risks might be, and how the potential results will benefit mankind.

This is particularly important, he says, in the case of decentralized trials, in which patients, enabled by today's technology, interact with the clinical trial staff remotely, rather than within the four walls of a clinical trial site. By making it easier to take part in a trial, decentralized operations enable participation by more diverse sample populations—provided that these populations' reservations about medical research are adequately addressed. An example of this approach would involve reaching out to potential clinical trial participants via various channels such as social media, email, text/SMS, telemedicine, and video calling for patient education, engagement, enrollment, and direct data capture. This is likely to help with trust-building, diversity, inclusion, and participant retention.

"For fear and mistrust to be dispelled," says Dr. Sharlene Brown, Director of Business Development for Jeeva Informatics, "it is incumbent upon research organizations and government representatives to acknowledge the reality underlying previously under-represented populations' concerns. Unfortunately, people have not atoned for what they have done, not apologized, or even admitted to the existence of a problem. The onus has been placed on the disenfranchised to correct the issue, which makes no sense."

The organizers of clinical trials, Dr. Brown says, need to be educated on how to approach, recruit, and retain participants. The educational curriculum for these people should include strategies to overcome linguistic and cultural barriers that stand in the path of inclusion and decentralization of clinical trials.

Incentives and regulation
In the absence of incentives for sponsors of medicinal products to strive for more diversity at their own expense, says Dr. Rajasimha, regulatory guidelines or mandates have to be put in place. Regulatory agencies such as US FDA, EMEA, or JPA can play a big role, but they also suffer from their federal or regional mandates.

The Helsinki Declaration and the Belmont Report—documents that establish medical ethics in clinical trials—may need to be revised or more multi-national declarations can help overcome some of the mistrust in global clinical trials. Certification bodies such as the Association of Clinical Research Professionals (ACRP) can consider upgrading their curriculum to include decentralized clinical trial methods for improving diversity, equity, and inclusion in clinical research.

Whichever way it is addressed, trust-building, says Dr. Rajasimha, is absolutely essential to bettering not only the percentages of minorities willing to participate in clinical trials, but also to knowledgeably protect themselves in circumstances like the current pandemic.

Trust, he adds, is hard to earn, especially in remote or decentralized models, but easy to lose. "The medical research community," he says, "needs to plan and work toward earning the trust of diverse patients in both in-person and online settings. It cannot be assumed or taken for granted."

About Jeeva Informatics
The personal experience of losing a child born with a rare disease and a brother with a chronic disease became the springboard for Dr. Harsha Rajasimha to apply his years of postdoctoral training at NIH and FDA to accelerating therapies for rare and common conditions. He knew that technology in itself is not the limiting factor and that patient-centered design guided by stakeholder needs and regulatory requirements would guide their continuous learning digital platform. By digitizing and automating manual repetitive tasks and reducing the logistical burdens on patients and study teams by over 70%, Jeeva accelerates the process of bringing new medicines or vaccines to patients who need them by over 3x faster. The Virginia-based company's modular software-as-a-service platform is fully scalable and facilitates patient enrollment, engagement, and evidence generation in clinical trials on any browser-enabled mobile device. Visit https://jeevatrials.com/

1.    "Latest Data on Covid-19 Vaccinations by Race/Ethnicity." KFF, 22 Sept. 2021, kff.org/coronavirus-covid-19/issue-brief/latest-data-on-covid-19-vaccinations-race-ethnicity/.
2.    "People Fearful of Taking Part in Vital Clinical Research." ScienceDaily, 16 Mar. 2020, sciencedaily.com/releases/2020/03/200316104010.htm.
3.    "How the US Government Used Black People as Guinea Pigs." New African Magazine, 20 June 2014, newafricanmagazine.com/3320/.
4.    Blakemore, Erin. "The First Birth Control Pill Used Puerto Rican Women as Guinea Pigs." History.com, A&E Television Networks, 9 May 2018, history.com/news/birth-control-pill-history-puerto-rico-enovid.
5.    Nix, Elizabeth. "Tuskegee Experiment: The Infamous Syphilis Study." History.com, A&E Television Networks, 16 May 2017, history.com/news/the-infamous-40-year-tuskegee-study.

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