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The Growing Use of Wearables in Clinical Trials
Wearable sensors have the potential to dramatically reduce the duration and cost of clinical trials by enabling objective, real-time, real-world data to be used as health outcomes measures. While most efforts to improve clinical trials have focused on making the existing processes more efficient, wearables represent a real game changer.
Pharmaceutical development is in crisis. According to the Tufts Center for the Study of Drug Development, it now costs US$2.6 billion to bring a drug to market, which is a 145 per cent increase in 10 years. While some question Tufts’ methodology, there is no question that costs are exploding. There are many reasons for this dramatic increase, but part of it stems from the changing nature of healthcare. With ageing populations around the world, 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 per cent of healthcare spending in the US was on adults with chronic conditions in 2006 and that number will continue to go up.
In this context, many of the reliable old measures (such as five-year survival rates) are now irrelevant. Today, many studies end up relying on subjective measures, such as doctors asking patients how they are feeling or how much pain they are in, to gauge quality of life. Not only is this highly subjective, but patients will just answer based on their experiences during the past one to two days. As a result, these measures are unreliable and uncertain. To get more reliable data, clinical trials need larger sample sizes, which drive higher costs and longer trials. And, often that is not enough. Most pharmaceutical companies have stories of a drug that looked great in Phase 2 trials, only to fail in Phase 3. Adding to pharma’s woes is a crowded market where cost containment has emerged the driving factor. Just about every condition has an existing treatment, and many of them are quite good. As a result, the incremental increased value from new treatments is getting smaller. Profits are getting squeezed. Deloitte conducted a study last year that estimated the return on pharma R&D at 1.9 per cent. That’s less than a U.S. Treasury bond. No company will continue to invest for long at those rates of return.