Challengers of the Status Quo in Clinical Trials — Faster, More Accurate Studies Using a Decentralized Approach

Some say that the clinical trial ranks among healthcare’s greatest inventions, replacing opinion, dogma and superstition with evidence as a way to judge medical interventions. The prowess of the clinical trial to arrive at medical answers was on full display in 2020, with the testing of the COVID-19 vaccines and the proof the trials yielded that the vaccines were safe and effective.

But 21st century version of the clinical trial is also enormously expensive, administratively complex and a contributing factor to the soaring cost of developing new drugs. Drug developers are conducting an increasing number of clinical trials in developing countries, a trend that raises troubling ethical questions as well as the practical obstacles poised by regulatory, language and cultural differences.

Ivan Jarry is not waving a magic wand. But the CEO of Obviohealth says that companies like his that run decentralized clinical trials can solve many of the problems that bedevil clinical trials, making them cheaper, faster and more inclusive and their results more reliable. At the same time, Jarry doesn’t want to be seen as a sower of mass disruption.

“We’re looking at processes and just trying to improve them using technology,” he says. ObvioHealth works with the large contract research organizations (CROs), such as Icon plc and IQVIA Holdings Inc., and is in discussion with CVS and Walmart, who have been getting into the clinical trials business, according to Jarry.

“It’s not that we’re going to change from one day to another and suddenly everybody’s going to go decentralized,” says Jarry, who has been CEO of ObvioHealth for three years after spending two decades at SPRIM, a life sciences consulting firm headquartered in Singapore. SPRIM is an investor in ObvioHealth.

Clinical trials today typically involve setting up study sites at physician offices, hospitals and other providers. The trial’s sponsor, often working through a CRO, pays the providers to recruit patents, administer the intervention, follow protocols and collect data. The study volunteers travel to the sites for tests to answer questions and to get the experimental treatment or, if they are in the comparison group, a placebo or another treatment. Clinical trial work can be lucrative for providers but also burdensome. “They are usually not happy to have dozens of new kinds of software to learn and be trained on, because every single sponsor, every single CRO, will have a new way to enter data,” Jarry says.

ObvioHealth and other decentralized clinical trial companies say they can streamline the work using apps and cell phone and laptop video cameras to gather data and enable communication between study coordinators and study volunteers. The medications or devices can be delivered to people’s homes. All that convenience speeds up recruitment and lowers dropout rates, and the app and cameras make data collection easier, more thorough and more accurate, in Jarry’s telling: “You can get people at home taking the medicines the way they do it normally, not rushing to a study site.”

Faster and easier recruitment can mean studies with greater statistical power, Jarry says. Collecting data from home devices can mean more precise end points. Jarry gets excited talking about recent discussions with a potential client about research involving autistic children. Language improvement is a common way to measure the effect of autism interventions. In a traditional trial, that would involve periodic testing of the child at a study site, a situation that is likely to be stressful and therefore affect speech. Instead, Jarry has proposed collecting data through microphones in smart speaker technology, such as Alexa. A trial that might take a year would be done in three months, and the speech improvement would be more accurate, he says.

Large pharmaceutical companies are risk averse, so they tend to stick with the established CROs. Jarrysays ObvioHealth has worked mainly with smaller biotech companies. The company has signed contracts to conduct approximately 60 studies, and approximately 18 are completed. The company has approximately 130 employees and 40 people who work as independent contractors. In 2012, it raised $31 million in its second round of funding, and Jarry says it is gearing up for a third.