For many of us, wearable devices are now a way of life. Our wristbands or smart watches can track how many steps we take on a daily basis, how much we sleep (or don't!) and even things like calorie intake or blood pressure. That data provides valuable information about our fitness progress and goals and even our overall health. While that data paints a helpful picture for the individuals with wearable devices, it also has the potential to change an entire industry.
Bringing a pharmaceutical drug to market is no small task, and drug companies have to be certain that the drug is both safe and effective before it is made available to the general public. Given the inherent risks, the industry has operated using tried and true practices, but those practices often move very slowly. From the time of molecule discovery, it typically takes a manufacturer 10-12 years to get that medication into the hands of consumers. Patents are issued upon discovery and are good for 20 years, so manufacturers only have an 8-to-10-year window to recoup research and development costs and make a profit before the drug can be made available in a generic form.
One of the most critical aspects of the process is clinical trials, and it's in these trials that manufacturers observe, measure and test the effectiveness and suitability of a particular drug. However, these trials take time. “Out of those ten years in average…the clinical trial part is taking a very relevant part, something like six, seven years,” said Jean-Marc LeBideau, Director of the PAREXEL Engineering Solution Incubator, during the 2017 OSIsoft EMEA Users Conference in London. Lack of patient participation and inability to remotely monitor adherence and patient condition are consistent hurdles, and these factors can extend the clinical trial process for months, or even years.
For PAREXEL, a consulting company for the pharmaceutical industry, the combination of wearable devices and the OSIsoft PI System proved to be the perfect duo to optimize the clinical trial process. The team developed the Patient Sensor Platform, which allows patients to connect wearable devices to the data hub and PI System via Bluetooth connection. During the initial study, half of patients were monitored on site and half were monitored remotely using wearables and, upon analysis, there was little-to-no difference in the patient data.
Using PI AF SDK, PI Web API and Asset Framework, the PAREXEL team is able to visualize clinical trial patient data in context with other pertinent information, such as demographics. Now, with this steady stream of patient data, pharmaceutical companies have access to important information, such as blood pressure, heart rate and sleep patterns, all without a patient setting foot in a facility.
With the right combination of wearable devices and the PI System, pharmaceutical companies can increase patient participation and clinical trial adherence, which has the potential to significantly shorten the clinical trial process. If drug companies can safely expedite the process of bringing drugs to market, patients have access to life-saving medication much more quickly, while drug companies have more time to recoup research and development costs during the patent period.
Click here to learn more about how PAREXEL is using wearables and the PI System to revolutionize the pharmaceutical industry.