by Michael Shanler

We’ve seen an explosion in wearable devices.  As for impacts of IoT and wearables in life science?  We are in the early days.  Today, some clinical trial designers are  leveraging technology on the wrist, over the chest, or on dermal patches for remotely monitoring heart, sleep, activity, motion, etc. Some data can even be integrated into diaries, data capture, source, and reported outcome systems.

But what about the prospect of remotely collecting more data from within the body?   Well, pay attention.  In the near future,  externally measured readings will be augmented by more “consumed” and enveloped views.  This will enable the paradigm to shift from inferred and indirect interpretations to more directly measured metrics.  The expanding clinical device ecosystem will blur the lines between what is considered remote, mobile, implantable, wearable, and ingestible.

Earlier this week, Oracle announced a new cloud service  for patient medical adherence in clinical trials.  This service will leverage Proteus Digital Health Feedback system  (aka digital pill technology). Proteus has developed a digital “ingestible”  that communicates with an external patch that connects to a mobile phone app.  If you haven’t seen it, this is pretty cool stuff.

This is an important step as it represents the first real foray of ingestible technology that is broadly applicable to clinical trials.  See, drug trials fail for a variety of reasons and poor patient adherence is a fairly common issue.  This technology enables sponsors to capture if indeed, a drug was taken- as dictated in the clinical protocol.

In order to take the costs out of R&D, clinical trial sponsors need better confidence in the data.   “Going digital” in this space means we need to leverage a bevy of new and pervasive data sources. Granted, Oracle initially has exclusivity with this Proteus application, but we will see more companies like Proteus and Oracle develop relationships and create new services that leverage pre-validated technology stacks.

Although “hyped” technology like this is uber-cool, not every organization will be quite ready to leverage it at the same time.  Clinical groups are still figuring out how to operationalize wearables (See Life Science prediction).  Oracle and Proteus are still figuring things out.  Only a few pharma companies have really tested it and the total costs are not transparent, yet.  However, this technology and other similar ingestible and implantable sensors are coming down the pike for clinical trials in 2015-2016.  Organizations will need to address skills, controls, processes, and workflows, the “hype” of the technology, and the ability of the group to adopt.

The emergence of this technology category also begs for a few higher-level strategic questions to be addressed:

  • How much more information could be directly captured from the source (e.g. the patient)?
  • Will patients in your trials be comfortable with this sort of technology inside them, and under what conditions?
  • Can technology like this not just improve confidence in your patient adherence data, but also lead to better trial results?
  • Can this technology be leveraged to go beyond clinical trials and bring back value to your organization? What about after drugs are launched?
  • Can the ingestible technology be used to better predict or correlate safety and efficacy, using your current analytics and staff?
  • What if other sensors similar to this one are developed? What other insights could be leveraged? How can the data be monetized or leveraged? What about security?
  • What is the desired “to be” environment, enabled by technology in the clinical space. What are the new business outcomes?
  • Is your business ready? Can you leverage technology like this to disrupt your space?

Here’s a link to our  first take (G00274190) on this news announcement.  Also, stay tuned for more.   In 2015, we will delve deeper into new sensor-technology and the impacts on clinical trials.
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Gartner, Inc