Back in 2017, many of us in the Pharma Informatics industry wrote opinions about wearables in clinical trials. In fact, it was the year we were all fixated on it. This new technology was partly driven by the mega trend of leveraging tablets and smartphones in eCOA and replacing paper surveys, which naturally extended to wearables. This is, after all, leading us to reliance on the patient to report outcomes and removing the risk of non-adherence. Why not eliminate the middleman and let the wearable report information directly and automatically?
Let’s begin by sharing a true medical story that I heard recently at the White & Williams TeDx Talks held in Philadelphia. An emergency room doctor shared a story of a grade school teacher who fainted in class and was brought in the emergency room. Oddly enough, this same episode had happened before – approximately about the same time of day. There were no other obvious symptoms. However, upon looking closer, the attending physician noticed that the patient wore a Fitbit daily so he decided to look further into the historical data. After some analysis, the doctor began to notice irregular heart beat patterns immediately preceding every episode; that was enough information to aid in the diagnosis of the patient’s condition.
Another headline that I read recently : “Popular New Exercise App Just Tells Users They Ran 5 Miles A Day No Matter What!” If you are like me and fixate on your Fitbit and wonder if you have done your obligatory 10,000 daily steps, this was a must-purchase. As an FYI for the gullible, this was a headline from The Onion (which is an online satire magazine).
I bring up the two examples (one serious and the other, lighthearted) to illustrate that we really don’t know if these wearables are accurate enough for transmitting even simple stuff. My question then is: Who is willing to be the validator of mHealth Apps and wearables?
A well-funded company in Silicon Valley purporting to have a platform for evaluating mHealth apps and a couple of researchers – both clinical trial veterans from Children’s Hospital of Philadelphia – developed a formal process aided by technology to design, develop, and conduct a study to determine efficacy of mHealth Apps. Both are early stage startups, but I am sure that there will be many more entering the fray.
Perhaps this could be a new revenue model for CRO’s? Imagine the possibility of approaching the Silicon Valley and offering to validate their platform(s) instead of waiting for a sponsor to decide to include same in a broader study. Business possibilities for CRO’s are endless.
While mHealth apps and wearables will continue to generate data, the downside is the sheer volume of it. This means CRO technology infrastructure must change and become highly adaptable to ingest large volumes of data from many, many sources and have a way to sift through that data and filter relevant data leading up to the critical study endpoints. Let’s not forget that these wearables and mHealth apps are controlled by third-parties and, to date, do not follow any standard data formats. CRO’s not only need to build these platforms, but they will need to allow for the maintenance of this platform as these data collection devices change firmware and data feeds.
As the velocity of technological advancement increases, CRO’s need to be prepared and by making the right investments and partnerships; they can position themselves to take advantage of this upcoming mega-trend.
Sina Adibi is the CEO of Adaptive Clinical Systems and a veteran of Pharma and Health IT industry.
About Adaptive Clinical Systems
Adaptive Clinical Systems offers a unique, simple, secure, validated, compliant, and cost-effective innovative solution for clinical data integration and interoperability. The cloud-based innovative Adaptive eClinical Bus® solution integrates clinical study data from multiple systems and platforms — EDC, eCOA, CTMS, Medical Imaging, IRT, analytical/data visualization systems and others — to ensure accurate and efficient transfer of clinical data for any study of any complexity while going well beyond simple and difficult to scale integration to full, real-time interoperability.
The award-winning Adaptive eClinical Bus software includes “connectors” for many leading clinical trial software tools from well-known vendors such as Omnicomm, Medidata, BioClinica, and Clinical Conductor to open source clinical trial tools such as OpenClinica and Clinovo. Connectors can also leverage internally-developed and proprietary systems and help customers retain their competitive edge. Adaptive Clinical’s eClinical Bus® can easily integrate technology into an interoperable, efficient, and accurate clinical trials system that streamlines processes and improves data reliability and offers the freedom to choose the best eClinical tools of any third-party or proprietary systems while enjoying all the benefits of a fully integrated system.