Clinical Insights: Progress Being Made With Mobile Technologies

By Ed Miseta, Chief Editor, Clinical Leader

In part 1 of this interview, Zaher El-Assi, president of Merge Healthcare’s eClinical division, discussed trends in global trials. In this article, he discusses the status of mobile technologies in clinical studies and the promise they hold for transforming trials via their application to Big Data.

Ed Miseta: Do you see any progress being made in the clinical adoption of wearable devices?

Zaher El-Assi: That is a highly relevant question. Today, wearable devices do not collect that much data, but there is certainly a beautiful promise of what can come. For example, Novartis and Google are developing a contact lens that can measure glucose levels. We have also seen implantable devices that can collect electrophysiological measurements. But none of that is really being used today. What we currently see in trials is counters of calories, steps, and heartbeats. That’s not a lot.

Where this becomes interesting is from a patient recruitment and engagement perspective. People love technology and I think this is a great way to engage with them. I picked up an Apple Watch and have been playing with it. It would be cool for it to remind me to take my medicine and then follow-up to ask me if I took it. That alone could eliminate having to go places, logging into apps, and keeping diaries. When we get to the point where we can interact with patients on a day-to-day basis and make those interactions much more personal, then I think the industry will start to take a much closer look. That day is definitely coming; it’s just going to take a little more time to get there.

Miseta: Are there any interesting technologies you have come across?

El-Assi: It’s not wearable, but I have a device called the Scanadu Scout. It is about the size of a hockey puck. You hold it to your forehead and press a button, and it provides you with a handful of vital signs, including temperature, heart rate, and blood pressure. It’s a really amazing device that will help patients to record medical information. The future of these devices is awesome, and I can’t wait for it to get here. There is a lot of sex appeal in wearable devices, and I believe the Apple Watch will do wonders for patient recruitment.

Miseta: There also seems to be a lot of confusion about these new technologies.

El-Assi: Absolutely. I have read stuff out there about how wearable devices are going to deliver personalized medicine. I don’t think that’s true. I think that Genomics will deliver personalized medicine. It will not come about by someone tracking steps, calories, and heart rate. These devices are real, they are cool, and they have a certain allure. But initially all we will get from them is some help with recruitment, retention, and patient diaries. I think we are still years away from any other uses. And remember this industry also moves very slowly. 

Miseta: I have head you say that you do believe they have the potential to help with Big Data.

El-Assi: Yes. Instead of looking at the data of a patient at one point in time, we can look at all their data, all the time. When I started in the clinical field in 1996, the typical study had 10 or 20 case report forms, and one case report form had 20 or 30 data points. That is a total of 600 data points per patient. We are running a trial today that has 2 trillion data points. That is insane, but as we collect more data on patients I believe we will have a much better idea of what is going on.    

Of course when you move into the Big Data world, it is not possible to analyze every single data point. There is a massive volume of data, there is a tremendous variety of data, and we are dealing with a great velocity. We collect data very quickly, we have to analyze it very quickly, and we need to react to it very quickly. With technology we have available today, a researcher can be immediately notified if a patient’s vital signs veer into the danger zone. These are advances that will certainly change the conduct of trials.

Simply put, as data sets grow, we will be required to change our behavior. We will need to stop looking only at the data and start looking at the outliers and the relevant changes in the data. If you are collecting heart rate data on every patient every minute throughout the day, that information is almost irrelevant unless something happens or there is a trend that can be identified. Four or five mobile devices collecting data every few seconds from each patient over a six-year period adds up to an awful lot of data. This is how we will get so many millions of data points. But eventually it will help us deliver more adaptive trials and get the right dose to the right patient.

Miseta: Who is currently driving technology adoption in the industry?  

El-Assi: Twenty years ago it was a CRO decision. Then we had the drug and device companies start dictating the technology solutions to the CROs. But I think we are starting to see that decision go back to the CROs. A lot of CROs finally started pushing back and saying, “look, you hired me to do a job, so let me do it the way I do it best.” While the top 10 pharma companies might still be driving many of those decisions, CROs are getting more flexibility to standardize. I believe that will be good for the industry.