Smart Technology Brings Virtual Clinical Trials to the Patient
March 12, 2021
by Danny Levine
Though the advent of smartphones and inexpensive sensors enables the capture of data that reveal subtle changes in health as people move through their daily lives, Glen de Vries notes that not much has changed for decades in the way clinical trials are conducted or how data is used in those studies.
De Vries, co-founder and co-CEO of Medidata Solutions, should have a good sense of this. His company is the most used data platform for clinical trials around the world. In his book The Patient Equation: The Precision Medicine Revolution in the Age of COVID-19 and Beyond, he takes a broad look at the precision medicine revolution and the potential for digital technologies to transform the development of therapies and the treatment of patients, as we have all become encased in data.
“It’s just kind of streaming around us everywhere and whether it’s the technology that’s in our pocket or on our wrist, or maybe things that are biologically more feasible to do, not just from an iPhone perspective, but can we start to monitor with medical-grade sensors over time, or even just expand the dialogue with our doctors so those conversations can happen any time. I think the big difference is that we’re going to start to see these continuums where we can actually see the rate of change, not just these single moments, as part of how we think about diagnosing disease, managing disease, making sure people are getting the right treatments. That’s a giant paradigm shift we’ve probably been waiting for, literally millennia, to have happen, but I think we’re about to really live through that at the scale. It’s pretty exciting.”
De Vries talks about the need for clinical trials to change in a number of ways. This includes creating better access to clinical trials, which tend to occur at centers in major metropolitan areas. One consequence of that is that there are geographic as well as socioeconomic barriers to accessing these trials much as in the healthcare system more broadly. “We have an ethical obligation to try to solve that,” he said.
He believes technology can play a role in helping doctors better identify candidates for clinical studies and enable the use of virtual clinical trials to bring the study to the patient. Some trial sponsors used such technology to avoid shutting down studies during the pandemic, and the U.S. Food and Drug Administration expressed openness to taking such steps.
“We used this assumption that we can get the doctor and the patient in the same room at the same time. And now we see that’s not a great assumption,” said de Vries. “It’s not a great assumption for having a meeting or having a birthday party. We’re all starting to do it virtually.”
He noted many companies have started to find ways to ship a drug to the patient at their home or get it to a pharmacy near them. Instead of traveling to an academic medical center hundreds of miles away from where they live, they can avoid having to miss work to participate in a clinical trial.
While de Vries acknowledges that there are risks for drug developers to push into new ways of gathering data and employing new endpoints, he said that the rewards far outweigh the risks.
As an example, he points to multiple clinical trials for treatments for the same disease, each using its own control groups. In such a case, there are double the number of patients serving as controls who are not receiving the new therapy and limited evidence on which of the treatments is the best therapy for individual patients since they were in separate experiments. In a digital environment, he said, all of that data can be brought together to create a patient pool that spans both individual experiments and provides additional insights into why an individual might benefit from one therapy or the other.
One of the issues is that there is a lot of data held captive by companies, hospitals, and universities. A consequence of this is a disconnection between the pharmaceutical industry and clinical care. In his book, de Vries talks about the need to unsilo data, but that de Vries acknowledges will require a mind shift.
In the world of rare disease, he argues that it’s even more critical to promote this type of data sharing because of the small patient populations.
“You have to start thinking differently about combining data that’s in a clinical trial with data that came from practice outside of clinical trials and figure out how to (and it’s possible) create a mathematically responsible, scientifically reliable environment to look at the evidence you’re generating from different sources of data outside of that silo of one experiment,” he said. “The industry is going to get there by necessity.”
RARE-X agrees with that vision. Suppose we are to accelerate the diagnosis and treatment of rare diseases. In that case, it is essential to create an interplay of clinical and real-world sources to provide greater insight from broader populations than single experiments can provide. RARE-X hopes its federated data platform will help enable researchers to do that.
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