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Therapeutic Areas for Wearable Devices in Clinical Trials

Regardless of geography or therapeutic area, wearables offer an important, exciting opportunity to better understand patients and improve their experience at each stage of their journey. Today, wearables are demonstrating real potential to transform data collection for clinical trials and accelerate the role of technology in clinical development. But to get there, pharmaceutical companies must take a disciplined approach and focus on five critical actions to succeed.

Wearable devices are currently growing hugely in popularity, with predictions that the market will grow to $25 billion by 2019.

Wearable devices and sensors offer great potential in the collection of richer data and insights to enhance our understanding of the effects of treatment. They enable the collection of objective measures of intervention effects both in-clinic and in remote free-living settings. However, implementing wearables and sensors brings new challenges to clinical trial conduct, data management and interpretation.
Insights collected by wearables will help you to understand and successfully address the complexities of implementation of wearable devices in trial design, execution and reporting. Direct experience helping pharmaceutical companies navigate this difficult terrain shows that the industry is only starting to understand how and when to test wearable technologies and take advantage of them in the clinical trial setting. Many have yet to learn the art of 'win fast, fail fast' or how to leverage proof of concepts (POCs) vs. larger pilots. A measured, practical approach to adopting new technologies has been proven to yield better ROI, more efficient use of time and resources, and valuable learning opportunities.
Many of these devices, like the FitBit or Jawbone, are fairly cheap and affordable to the public. With the rising prevalence of chronic conditions like obesity due to our increasingly sedentary lifestyles, the use of wearable technology is on the up. Although initially marketed to consumers wanting to track their health and fitness, many wearable medical devices are now being designed and their potential use in clinical trials could completely transform and revolutionize the pharmaceutical industry. The obvious benefits to incorporating wearables in clinical trials are a higher compliance rate and reduced dropout rate, because wearing a device to monitor various vital signs and endpoints can reduce the need for hospital visits. For the same reason, clinical trials could have a much higher uptake and recruitment rate. The large amount of additional data could mean a lower variability, so fewer subjects could be needed to achieve statistical power. However, this concept is virtually brand new and has major questions that need to be answered before real progress in this area can begin.
The amount of data produced by round-the-clock monitoring is a double-edged sword - huge volumes of data need new techniques for storing, processing and analyzing it, and pharmaceutical statistics and "big data" methods have previously been worlds apart. "Big data" is booming and has become a buzzword, with new courses teaching Data Science springing up every year, as companies look for new ways to extract maximum knowledge out of their data. Analysis of big data often involves large-scale Bayesian methods and machine learning and is based on finding patterns and prediction, whereas clinical trials mainly use traditional statistical methods for inference, such as hypothesis testing and linear regression.
The big question is: will the pharmaceutical industry be ready to start using these new innovative methods?
The industry has a fairly risk-averse culture due to standards imposed by regulators, and faces little pressure to innovate the R&D (Research and Development) process unless there are clear efficiency gains leading to cost savings.
Secondly, what can wearable devices reliably measure and which therapeutic areas could they actually be used in?

WorldBI Author