In 2012, the average smartphone had more computing power than the Apollo 11 mission forty-six years earlier. In other words, the phone in your hands has more power than NASA had to get a man on the moon. The adoption and growth of wearable technologies is a clear indicator of this expansion. Wearable technologies, or “wearables”, refer to electronic technologies, or sensors, that are incorporated into items of clothing or accessories, which are comfortably worn on the body.
Due to adoption rates, and consumer engagement with wearable technologies, they are quickly becoming the focal point of a paradigm shift within clinical trials. The real-time data being reported will help sponsors understand and potentially identify emerging adverse events or potential complications. Jack Whelan, an ePatient and Research Advocate, states that “providing real time data is much better than waiting to see a physician. And if there are adverse effects emerging, the company that sponsors the clinical trial uses this information to look at biomarkers quicker, sooner, faster, and I think this is an important part of using mobile devices in clinical trials. Reporting information in real time, rather than waiting.” The data collected from wearable technologies, partnered with mobile devices, is ushering in a new era of clinical trial research. Here are three ways that wearable technologies are transforming clinical trials.
- Accurate Data Collection
According to mHealth news, obtaining timely, accurate data from participants has been an ongoing challenge in clinical trials. Even in highly incentivized clinical trials, researchers struggle with getting participants to travel to clinical sites for testing. It’s even more difficult to get accurate data through manual methods such as journals, paper based surveys, questionnaires, and reports.
Wearable technologies are part of the data collection solution. Wearable sensors allow for continuous bio-monitoring without manual intervention. In other words, patients can be passively tracked 24/7, including when they are sleeping, ensuring accurate and timely information. This data can be analyzed to produce valuable insights into individual and population trends over time.
In addition, wearables help to expand the type of data that researchers can collect and analyze. For example, a sensor could be used for continuous non-invasive blood pressure (NIBP) measurement. This data can be measured continuously, making it incredibly meaningful for both researchers and patients in trials, such as hypertension and heart failure. Other potential uses include wearables show promise in addressing a range of medical conditions from diabetes to dementia. When applied to clinical trials, wearable technologies are a powerful research tool that can be used to gather clinical data in real-time while providing remote patient monitoring.
- Adverse Event Reporting
Wearable technologies are helping to create a more efficient clinical trial by allowing researchers to understand and potentially detect adverse events sooner. Issues that once required an office visit to collect data can now be handled through mobile or wearable devices. The data reported is in real-time, which could result in more accurate data than having to rely on patient-reported paper diaries.
For example, consider a patient with congestive heart failure who is enrolled in a clinical trial for a new drug going to market. With mobile health monitoring and wearable technologies, this patient can be closely monitored for health changes that require attention. Weight, blood pressure, and daily habits can be monitored in real-time. Even off-the-shelf wearables, like the Apple Watch which contains “basic” bio-sensors, that can track heart rate, balance, sleep pattern, gait, activity level, hearing, and speech. Most importantly, these functions only require a user to wear the Apple Watch. The data is tracked automatically and continuously.
- Save Time and Money
According to Pharmaceutical Research and Manufacturers of America (PhRMA), the total cost of Phase I-III research has increased by 250% since 2001 (nearly $40 billion dollars). One of the major factors contributing to this is that the initial capture of data continues to be done via paper. The traditional data capture method can creates transcription errors, delays between data capture and data entry, and often requires verification of paper source documentation. By replacing paper with electronic documentation, there is an opportunity to save both time and money.
The game changer is the ease of data collection. By simply snapping on a wristband or tag onto your clothing, you are automatically collecting data. This data can be sent in real time to a trial sponsor, clinical site, or physician. The traditional data collection method for clinical trials relies on the patient being consistent and reporting data correctly through a paper diary. This creates opportunities for error and potential problems. Transitioning from paper based processes to electronic will make patients experience within a clinical trial much less burdensome and could help to ease the burden on clinical trial participants while seamlessly integrating into the participants life, which could help increase participant engagement and retention in a given clinical trial.
At Parallel 6 we are passionate about improving clinical trials. The Clinical 6 platform is an enterprise strength cloud-based technology that enrolls, engages, connects, and reports on subjects anywhere in the world through a single interface. It’s built to improve patient engagement and retention by seamlessly integrating into patients’ lives and connect with mhealth medical and commercially available wearable devices. If you would like to learn more about Clinical 6, please give us a call at (619) 452-1750 or request a demo.