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.

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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.

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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.

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