Could Wearables Be the Future of Clinical Trials?Could an app on your phone or the FitBit around your wrist be the solution to the major costs, wasted time, and lack of participants in medical trials? Clinical trials are used to improve and create cures for diseases. They also have and will continue to save thousands of lives around the world. However clinical trials are not always successful and often the process doesn’t benefit its patients. With more advanced technology clinical trials can help save and benefit lives of millions of people struggling with diseases and disabilities.
Rick Morrison, the founder and president of the company Comprehend, says that “This is a dramatic change from traditional paper-based methods that have been at the root of the industry’s slow and costly methods of conducting global clinical research”(Rick Morrison, par 1). Though many cures have been found through clinical trials in the past, they are now rapidly moving towards a new era, with faster, more advanced data analysis, higher patient participation, and less wasted time and money all made possible by wearables. In the past, hundreds of clinical trials may have seemed like a hassle and waste of time to participate in. Clinical trials have proven to be dangerous with only a 31% success rate in phase 2 trials (Jill Wechsler,par 3). Many would agree that clinical trials are an extreme inconvenience; having to constantly schedule appointments to monitor vitals and statistics makes clinical trials unappealing. Unfortunately so far most wearable technology is not FDA approved for medical trials and is mostly viewed as a consumer product (The Potential of Wearable Technology in Clinical Trials, par 6).
Another possible issue with wearables is compliance– what happens if the patient removes his or her device? With patients having easy access to their vitals and daily measurements they could easily try to improve their lifestyle in order to see better results (Therapeutic Areas for Wearable Devices in Clinical Trials, par 11). This would mess with the trial data and potentially throw off all gathered information, because there’s no way to tell whether the medicine benefited the patient or the patient helped themselves. There is no doubt that the use of wearables in clinical trials has not yet been perfected and it may take a while to achieve flawless results. However companies are already working on ways to train participants to not mess with data, and others are creating algorithms to detect trial mishaps (Therapeutic Areas for Wearable Devices in Clinical Trials, par 11). Although wearables could take some getting used to, they are already being used in clinical trials today.
Currently, a clinical trial is being conducted at Johns Hopkins University with the Epiwatch, available through Researchkit from Apple. Researchkit is a software that allows medical researchers to easily and efficiently gather data, as well as organize and apply it in order to make finding cures simpler (Apple). The Epiwatch allows participants to track the onset and duration of epileptic seizures using the Apple Watch. If the patient starts to feel the effects of an oncoming seizure, “they can tap a custom complication on the Apple Watch this alerts the accelerometer, heart rate sensors and a notification is sent to a designated caregiver” (The Potential of Wearable Technology in Clinical Trials, par 5).
With Apple Watch technology, researchers can easily track the length and frequency of the trial participant’s seizures at the moment they are happening. Researchkit has many other possible applications. Already, there are apps for researching Parkinson’s disease, diagnosing Autism, finding ways to predict seizures, tracking and preventing melanoma, understanding postpartum depression, and many more. All of this is thanks to the technology on our wrists or in our pockets (Apple research and care kit).
One of the main reasons for unreliable data in clinical trials is simply the lack of participants. Increasing the number of participants would help make data more accurate and reliable. Currently only 5% of patients ill with a certain disease are participating in clinical trials that would directly benefit and find cures to their disease (George Underwood, par 11). An article published in the Pharma Times magazine discusses the issues of patient recruitment and how technologies such as wearables could make patients aware of trials they fit the criteria for and may be interested in participating in. Technology allows for remote trials, which could help find cures to diseases that vary in different populations.
A diabetes trial was recently conducted with 60 different participants located all over the world, all of which were recruited through Facebook. The study had zero onsite visits, and was fully conducted online through the cloud-based trial system Clinpal (George Underwood, par 15). The patients simply had to conduct easy at home glucose tests and the data was logged automatically, saving them check-up costs and time. The market for wearable devices is predicted to be worth 25 billion dollars by 2019 (Therapeutic Areas for Wearable Devices in Clinical Trials, par 1).
The best part about wearables is that they are very affordable for the public, since wearables were initially only intended to track fitness and diet to help build better lifestyles. Just several years ago in 2013 wearables were not very popular with only 25,000 shipments worldwide, today the total is just under 100,000 shipments worldwide (Therapeutic Areas for Wearable Devices in Clinical Trials, chart). With a constantly growing market wearables are a very common sight, but not often are they used or advertised for more than just tracking the number of steps taken in a certain day or how many calories were eaten. At the moment wearables are not well known or reputable for medical research or clinical trials.
With better advertising and marketing wearables may soon take over the world of clinical trials, helping create, track, and store data, affecting millions of people.As our society enters the age of technology so do our clinical trials, with phone applications such as Researchkit by Apple or wearable devices like FitBits, which are currently limited to more basic day to day health tracking. Some wearables are designed for specific conditions like the glucose monitoring wearable skin patch Abbott (Therapeutic Areas for Wearable Devices in Clinical Trials, par 3). With hundreds of wearables and apps on the market today it’s hard to ignore the benefits they bring with them. Saving valuable time, reducing trial costs, and producing more accurate widespread data are just some of the main benefits wearables and technology bring to our society today and even more so in our future. In an article, Niklas Morton and David Blackman say that wearables are “laying the foundation for the next revolution in clinical trial operations” (par 1).
In order to continue saving lives and fighting advanced diseases and assisting those with disabilities we have to improve or clinical trial process. The future of clinical trials relies on the use of wearables.