Clinical Research Processes Struggle to Adapt Amidst Pandemic

The pandemic has intensified worldwide research collaboration and a reprioritization and rethinking of the process of how healthcare is delivered or received.

If clinical trials for the COVID vaccines—research, development, and approval—were done in a matter of months, why … can’t that be the case with other clinical trials of desperately needed therapies as well?

The ongoing COVID-19 pandemic ranks as perhaps the most serious global health crisis of the past hundred years. Worldwide, to date there have been almost 262 million recorded cases and more than five million deaths. In the United States, the toll includes just under 50 million cases and nearly 800,000 deaths.(1) Meanwhile, a new variant of the Covid virus, omicron, was recently identified in South Africa and is already spreading around the world.(2)

Some bright spots are relieving this dark picture, notes Dr. Harsha Rajasimha, Founder and CEO of Jeeva Informatics. “One bright spot,” he says, “has been the speed at which vaccines against COVID have been developed. The pandemic has intensified worldwide research collaboration and a reprioritization and rethinking of the process of how healthcare is delivered or received.”

A very significant area of progress, says Rajasimha, is telehealth. The incidence of telehealth—virtual consultation with a medical professional via the internet rather than face-to-face—was 38 times higher in February of 2021 than it had been twelve months earlier.(3) Born of necessity, telehealth now offers a chance to reinvent in-person care models, with a goal of improved healthcare access, outcome, and affordability.

As noted, another key weapon in the battle against the pandemic is, and continues to be, an acceleration of the clinical trial process. If clinical trials for the COVID vaccines—research, development, and approval—were done in a matter of months, why, asks Rajasimha, can’t that be the case with other clinical trials of desperately needed therapies as well?

The answer, he says, is that advanced platform technology and the acceptance of telehealth is making this possible. According to a recent study from McKinsey & Company, as COVID-19-related care consumed health system and travel became limited, patients’ access to trial sites was reduced by 80%, accelerating decentralization and virtualization. This, notes Rajasimha, had a significant upside. In one survey cited by McKinsey, up to 98% of patients reported satisfaction with telemedicine. In another, 72% of physicians reported similar or better experience with remote engagement compared to in-person visits.(4)

Rajasimha notes that these findings helped identify some conspicuous weak spots in clinical trial procedures—particularly in the U.S., where the clinical trial ecosystem has been reported to be inefficient, siloed, and hampered by a serious lack of diversity among clinical trial subjects.(5) Partly as a result of the COVID pandemic, says Rajasimha, significant progress is being made in improving both efficiency and diversity in clinical trials.

What is essential, he says, is that this progress continues. “There is a widespread misconception that the COVID vaccines were developed so quickly because of the high efficiency of the clinical trial process. In fact, speed was made possible by FDA guidelines that allowed remote data capture, and by the willingness of patients to be part of fighting this new and terrible disease.”

That capacity for speed and flexibility, was not—and still in many ways is not—the norm. “It is, however, becoming the norm that is essential for us to ensure continuity and integrity of clinical trials,” says Dr. Rajasimha. “There is no efficient, reliable pre-pandemic mode of operation to which we can someday return. We need to go forward, not back.”

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.    “Coronavirus Cases:” Worldometer, worldometers.info/coronavirus/.
2.    “Omicron Variant Now in North America, Canadian Officials Say.” NBCNews.com, NBCUniversal News Group, 29 Nov. 2021, nbcnews.com/news/world/omicron-variant-now-north-america-canadian-officials-say-rcna6881.
3.    Bestsennyy, Oleg, et al. “Telehealth: A Quarter-Trillion-Dollar Post-Covid-19 Reality?” McKinsey & Company, McKinsey & Company, 22 July 2021, mckinsey.com/industries/healthcare-systems-and-services/our-insights/telehealth-a-quarter-trillion-dollar-post-covid-19-reality#.
4.    “No Place like Home? Stepping up the Decentralization of Clinical Trials.” McKinsey & Company, McKinsey & Company, 28 July 2021, mckinsey.com/industries/life-sciences/our-insights/no-place-like-home-stepping-up-the-decentralization-of-clinical-trials.
5.    “Clinical Trials Have Far Too Little Racial and Ethnic Diversity.” Scientific American, Scientific American, 1 Sept. 2018, scientificamerican.com/article/clinical-trials-have-far-too-little-racial-and-ethnic-diversity/.

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