Blog 13 - Clinical Trials in Crisis
Blog 13 discusses current difficulties within the Clinical Trials landscape, and looks at how adoption of wearable sensors can be one tool to help address these.
It's no secret that there is a crisis in the Clinical Trials industry. There are numerous causes, but two in particular stand out.
First, 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
Many existing wearable platforms have been built to primarily serve the consumer and academic 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.
The adoption of wearables within a wider industry move to decentralized Clinical Trials is growing at pace. According to Kaiser Associates and Intel, 70 percent of Clinical Trials will incorporate wearable sensors by 2025. Shimmer is committed in the development of our Verisense technology to have a robust system that will fit seamlessly into sponsor requirements for a wearable platform. We continue to engage with stakeholders and partners in the industry to ensure our development plans are in line with the ever evolving demands of Clinical Trials.
