One of the exciting and frustrating things about convergence, particularly in healthcare, is that it’s tough to predict how the hybrid technologies will find their way to market. The process of reaching that goal is filled with unexpected obstacles, twists and pivots.
Clinical trials offer a great example of how bipharma companies are making use of digital health devices and online social media to make drug development more efficient. In an interview with MedCity News at the BIO2015 conference in Philadelphia this week, Dr. Eric Topol called attention to the work being done applying digital health to reduce the cost of clinical trials, which would clear the way to lower drug prices. But even as the the director of Scripps Translational Science Institute and author of the recently published “The Patient Will See You Now” (and not so recently published “Creative Destruction of Medicine”) noted some of the interesting trends in this area he acknowledged some of the obstacles that stand in the way.
In the process of developing better drugs, it’s important to design better clinical trials that make use of technologies that can make the application process smoother and make it easier to generate and collect data.
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“Clinical trials today are extremely costly, laborious and slow…The model for doing research can be completely revamped now and that’s I think clearly quite exciting. Enrollment in trials can be done quickly and efficiently tracking through devices. We have some things that still need to be worked out. For example if someone provides consent — is it really that person participating? How authentic is that? Should we get biometrics into that? That hasn’t been done yet, but it can be done and should be done. You don’t want someone in a trial who has a surrogate participating.”
Topol noted that it’s impossible to say how common this because the information simply isn’t there because it is so new.
“We have done trials where we enroll through the Internet, for example, genetic studies where we collected saliva, all done through the mail..with thousands of people, so we have experience of that. But when you’re doing a trial with a sensor or drug or both …there are concerns about authenticity of the person and their participation. But I think there are technical ways to get that resolved but we gave not yet done over consent on authenticity. We haven’t yet done a mobile entry pharmacologic or bio-pharma trial, but it’s coming.”
Topol said he was impressed by the number of companies working with PatientsLikeMe to identify people to enroll in clinical trials is “quite remarkable.”
“The number of trials where diabetes is the principle condition being monitored — there are so many companies now that are using wireless digital glucose devices whether done by intermittant or continuous monitoring — and that’s been embraced as a way to rev up diabetes trials. Those are the two biggest things — clinical trial efficiency and diabetes….and networking with social online patient communities like PatientsLikeMe. It’s great to see that, because when I wrote ‘Creative Destruction of Medicine’ four years ago there was zero convergence…Now there are so many [examples].
He added that we’re still relatively early in the widespread adoption of digital health tools in clinical trials but that momentum is building. A clinical trial for macular degeneration offers an example of how digital devices can be used to help patient with self reporting.
“We are doing a trial with Genentech for macular degeneration testing visual acuity and we’re using an app that the person self administers to test visual acuity to see if the drug is working now. That’s an example of self-reporting through an app…Macular degeneration is a condition where we don’t have great treatments and it’s the leading cause of blindness.”
Read Part 2 of Eric Topol interview.
Photo: Flickr user Jônatas Cunha
