Thursday, February 19, 2015

Current state of Wearables and Clinical trials

I have been fascinated by sensor networks from my graduation days. Spent many sleepless nights playing around with Microcontrollers, miniature robots talking to each other over a close net WIFI network using XMPP. Then in 2005 something terrible happened, I got a job. My journey into software development world started. But electronics and hardware has always been my main inspiration.

My fascination with sensor network started from my pre graduation days, I hadn’t heard the term IoT at that time. It was all Wireless sensor network, building miniature robots sending messages to each other over bluetooth and closenet WIFI network. Good old days…

Looking at the current trend with wearable technology and healthcare industry, it seems that the way forward for clinical trials is remote uninterrupted data collection or Device Driven Clinical Trials as I like it to be called. This is nothing new, but the concerns I have is with the wearable devices available in the market today. These limits the usecase for collecting sensible data. For example commercial fitness band/activity trackers like FitBit,Garmin is more focused towards capturing the activity like Steps, Run some times heartbeat. These data is good to track ones activity but would fail when it comes to collecting data for a clinical trial [ it may sound exaggerated, but bare with me ]

Consider a usecase where a patient signup for a clinical trial which is using cutting edge technology to capture data from the patient. He would be given a traditional “fitness band”  so that his activity can be electronically captured.  What happens if the patient experiences a sudden increase in his heart rate? And data is captured in the EDC as at 7:00PM the patients heart rate is 110bpm. We cannot make sense of only one kind of objective data.

To have a meaningful metrics we need meaningful data. To capture meaningful data we need to have as much objective data as possible. To achieve this we need to look at the kind of wearable fit for the purpose.

IoT for the rescue:
I am using IoT loosely here. Internet of Things has become a phenomenon far greater than selfies. people took selfies even before the invention of digital cameras, but only recently ‘selfies’ became an internet rage.

IoT in wearables, in other terms can be described as connected sensor network. Below is a simple breakdown of what would consist of a wearable suitable in the field of clinical trials [ not just limiting to the ones mentioned]
Screen Shot 2015-02-18 at 22.19.58.png Screen Shot 2015-02-18 at 22.20.39.png

Heart rate at 110bpm alone does not given enough information, patient may be just playing, or having an argument with his wife or even it may be due to severe  side reaction to a drug. Other data such as respiration rate, perspiration and body temperature to name few we may would be useful. All these data can be transmitted in realtime to a cloud service and later imported to an EDC system.

These sensors can be embedded in a smart clothing, that we we won't be embarrassing patient by making them wear a computer over there neck and looking for a power outlet.

In the next post I will share the setup I have developed using Android/MQTT/RoR/MongoDB/ to capture the data into an intermediate datastore and later can be pushed to any Electronic data capture system