When I was in college my friends would head on over to a company called PPD to play lab rat in medical trials in exchange for pay. They would spend a day or a week sequestered in rooms where they were monitored, poked, prodded and fed a regimen of bills or placebos, all in the name of
science spending money.
But thanks to smarter connected devices, crowdsourcing trends and better medical data analytics and algorithms such clinical trials may become a thing of the past — or at least less of a burden. The launch this week of a crowdfunding campaign for the Scout, a home monitoring device that tracks, pulse, respiratory rate, blood pressure, temperature and other vitals, offers a perfect example of how clinical trials may change. As part of the company’s Indiegogo campaign for the Scout it’s inviting participants to opt into a what will become the usability study it submits to the U.S. Food and drug Administration for approval.
From the campaign web site:
Before Scanadu Scout™ can become a medical device it will have to go through the FDA (Food and Drug Administration) approval process and this is where your help comes in. With the Scanadu Scout™ you will help us by Scouting yourself and giving us feedback to refine the Scanadu Scout™.
This will happen in the framework of official clinical studies in which you will be invited to partake, ONLY IF YOU OPT-IN. For each study, some of you will be contacted and will have to sign an Informed Consent form. With your help we can put Scanadu Scout™ through FDA to become an over-the-counter consumer-grade diagnostic tool.
Scanadu, the company behind the Scout, isn’t the first or only company to recognize the power of connected devices, crowds and data, Transparency Life Sciences, a New York company started by a refugee from the pharmaceutical industry is also tackling the problem of slow, large and expensive clinical trials with crowdsourced data. TLS has built an online tool to collect information from researchers, physicians and patients that will then take their input to design an FDA-approved protocol for a drug study.
The FDA in December approved the first TLS protocol for a study on the effectiveness of a drug for Multiple Sclerosis patients. An industry consultant wrote that TLS took a process that takes 6 months and completed it in 6 weeks thanks to its ability to gather data from multiple sources into its tool that then formats the data properly. The study relies on remote patient monitoring to cut down on office visits, something that the Scout may one day be able to help with.
Remote monitoring cuts costs but also increases compliance and participation in the study, because it reduces doctor visits. Patients in the study still have access to a nurse or doctor and regular check ins, but they no longer have to spend a chunk of their day traveling to an office and waiting. While TLS and Scanadu are using the web to help speed up the FDA trial process, other doctors are thinking about using crowdsourced data to eliminate some of them, instead relying on crowdsourced data to monitor the efficacy of certain drugs and medical devices after their initial approval. And there are tons of startups out there thinking about finding and cataloguing patient data outside of formal trials, such as PatientsLikeMe, Medify and others in this story.
Much as mobile connectivity has changed the way people hail cabs, book tables at restaurants and share photos, the internet of things and the resulting data from consumer devices may soon change the way we test the efficacy and safety of our drugs. Figuring out the right balance of oversight and self-reporting in this new paradigm will be crucial, but it’s something that should happen.