HERNDON, Virginia—Within 3 years, India will surpass China as the world’s most populous country, with about 1.45 billion inhabitants. It already has more rare disease patients than any other nation.
Yet when it comes to clinical trials, India—like most of the developing world—is grossly underrepresented, said Harsha K. Rajasimha, PhD, founder and CEO of Jeeva Informatics.
“Historically, 80% of all clinical trial participants have been Caucasian, middle-aged males from an affluent background. This is not representative of the gene pool—even within the US, where people from lower socioeconomic groups, ethnic minorities, women, children, and people from rural areas have not engaged in clinical trials,” he said. “By making participation more widely available to anybody with a data device and access to the internet, we can significantly increase access, to about 60% of the world’s population.”
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That’s the idea behind Jeeva, founded in February 2019: to use innovative technology to improve the diversity, equity, and inclusion (DE&I) of patients in clinical trials.
Dr. Rajasimha, interviewed at his office here, cofounded the Organization for Rare Diseases India (ORDI) in 2013. Six years later, he launched a second nonprofit group, the Indo-US Organization for Rare Diseases.
He says this group aims to connect patient advocacy groups that already have patient registries, natural history studies, or any data-driven research in rare diseases, with patients and researchers in the Indian subcontinent and Southeast Asia.
“We believe by doing this we can significantly speed up the process of developing new therapies for rare diseases,” Dr. Rajasimha said. “There are some fantastic medical geneticists and scientists doing amazing research in India, although the funding, the scale, and the volume of research has been rather low. That’s where we want to see change occur.”
India seems particularly prone to genetic diseases caused by consanguinity, or marriage between relatives. Especially prevalent are hemophilia, thalassemia, sickle cell disease, and certain blood disorders.
At present, about 80% of clinical trials take place in the US and Europe. India, with nearly 18% of the world’s population, accounts for less than 2% of all drug trials, he said.
Dr. Rajasimha’s interest in the subject is not only academic. For 12 years, he had been involved in next-generation DNA sequencing in rare diseases at the National Institutes of Health in Bethesda, Maryland. But then, in 2012, his daughter was born with Edwards syndrome, a rare congenital disease. She never made it home from the neonatal intensive care unit.
“This experience helped me understand the patient perspectives and what the families suffering from rare diseases go through,” he said. Yet “most rare-disease therapies are developed in the United States and the European Union, and some in Japan. Much of the rest of the world has not been an active participant in clinical development of therapies and orphan drugs.”
In fact, Dr. Rajasimha said, low patient recruitment delays about 85% of all clinical trials and results in the termination of 30% of them. Every day a trial is delayed costs drug company sponsors between $600,000 to $8 million, he noted, and that even after enrollment, some 30% of patients drop out along the way, leading to incomplete data.
“We are doing our best to see how we can leverage technology to disseminate and educate people,” he said. “Most of these clinical trials take 10 to 12 years from when a drug is discovered to getting it to patients. I have been focused on where the bottlenecks are, and how can we make this more efficient.”
One way to do this is by helping a biopharmaceutical or clinical research organization (CRO) or trial site to configure software for a study within days, and then screen patients remotely on any browser-enabled device. Those who are eligible can be informed and educated about the research study, and then enroll themselves through informed consent.
“Electronically, they can sign on a screen using their mouse or a keypad. Then they are in the study,” Dr. Rajasimha said. “Historically, most clinical trials require patients to travel to the clinical site on a regular basis, so they have to rely on a caregiver to take them. Imagine the burden on the family. With our software, once they’re enrolled, they are able to participate with little or no visit to the clinic—and only if it’s absolutely necessary.”
He added: “Think about this in the context of the pandemic, ensuring that patients are safe and do not get exposed to the coronavirus and infections.”
Jeeva, launched in December 2020, currently has 7 enterprise beta projects running on the platform. In addition, a major US university has contracted with Jeeva to run a 5-year longitudinal cohort study with 2500 healthy volunteers.
“Our software allows clinical trial staff to verify patients on a daily basis. It has all the digital engagement to communicate, whether initiated by the patient or by the trial staff, by email, text, video call, audio call, and even complete clinical assessments,” said Dr. Rajasimha, adding that while on a video call, “the patient can maintain an electronic diary of their medication, symptoms, and adverse events.”
In July 2021, Jeeva won a $100,000 grant from Virginia’s Commonwealth Commercialization Fund to spur research in a variety of key technology sectors. The company also won a $25,000 grant through Prince William County’s IGNITE program for selected high-growth companies and tech catalyst organizations.
Recently, Jeeva finished a collaborative project with Georgia’s Kennesaw State University comparing the usability of Jeeva with RedCap software. Dr. Rajasimha said “the results have been positive, and are pending peer review for a journal publication.”
