Wearables in Clinical Trials

Wearables in Clinical Trials

Clinical Trials in Crisis

It's no secret that there is a crisis in the Clinical Trials industry. There are numerous causes, but two in particular stand out.

Firstly is the changing nature of health care. With our aging population and the success in treating infectious and other acute diseases, chronic disease management has come to dominate healthcare. In fact, one study indicated that 84% of health care spending was on adults with chronic conditions in 2006 and that number will continue to go up.

In this context, many of the old objective measures (e.g., 5-year survival rate) are now irrelevant. The initial response has been to rely on subjective measures, like a doctor asking a patient how they are feeling. Not only is this highly subjective, but patients will just answer based on the last 1-2 days. As a result, these measures are unreliable and uncertain.

To get even somewhat reliable data, we need larger samples, which drives higher costs and longer trials. And even that is often not enough. Most pharma companies that we have spoken with tell us stories of a drug that looked great in Phase 2, only to be rejected in Phase 3. According to a Tufts study*, it now costs $2.6 billion to bring a drug to market which is a 145% increase in 10 years.

On the other side, we have a crowded market. Just about every condition has a treatment, and many of them are quite good.  So the incremental values of new treatments are getting smaller.
Profits are getting squeezed in a big way, and this cannot continue.

*Source: Tufts Center for the Study of Drug Development (2014).



The use of wearables helps to address many of these issues, as wearables are a relatively low cost technology that can collect masses of data continuously from many participants in a substantially efficient and easy to use process.

 

 

Current Difficulties with existing wearable technologies

Existing wearable platforms have been built to primarily serve the consumer and research markets. They can be used in a makeshift manner for Clinical Trials, but generally the same difficulties tend to reoccur which increases the risks of non compliance:

  • Limited Battery Life - Requires user to regularly take off device to charge it
  • Non Waterproof - Requires user to regularly take off device when bathing or swimming
  • Display Data - Users can track their data, which tends to disrupt their regular routines
  • Uploading data - Generally requires user to take off device and manually upload
  • Lack of integrated platform - CRO's receive the data but do not have a streamlined platform to process it
  • Poor Quality Data - Data received is often below the standards necessary for clinical needs

 

How Verisense addresses these

Verisense is the first wearable solution built from the ground up that specifically aims to solve the current issues standard wearables experience when it comes to use in Clinical Trials:

  • Battery Life - 24/7, up to 6 months battery life. User never has to remove the device
  • Waterproof - Can be worn when bathing
  • No Display Data - Users do not have access to data on the device or online
  • Uploading Data - Verisense has Wifi & SIM communications. Once the sensor device is within range of the Verisense Base Station, data is automatically uploaded. No action from the user required.
  • Integrated platform on cloud server - CRO can receive data from numerous different sites to a centralized server
  • Highest Quality Data - Shimmer has long been recognized for the quality of data our platform outputs and our Verisense solution is no different.