CWWeekly presents this feature as a way to shine the spotlight on issues faced by executives in the clinical trials space. Writer Suz Redfearn spoke with Drew Schiller, chief technology officer and co-founder of Validic, an IT company that connects data from wearable and medical devices to companies across the healthcare ecosystem.
Q: It seems that wearable devices could, to some extent, do away with site visits for patients, shaving millions off the cost of running a trial. What has kept wearable technology from revolutionizing clinical trials in this way thus far?
A: Wearable activity trackers like FitBit have been around since 2007, but really it wasn’t until 2013 that these devices became a lot more prevalent in clinical care. It’s still a really nascent market, and to expect pharma to respond to a nascent market any faster would be unreasonable.
Healthcare in general is still trying to understand how to leverage the data coming off these devices. They see a lot of potential, but there hasn’t been a clear understanding yet of how these devices are going to fit into our current paradigm. We’re starting to see wearable trackers potentially replacing manually-entered, patient-reported data. Let’s say a CRO is conducting a study where sleep data is an important factor and researchers are trying to find out how well a person slept. Typically, this information was manually entered and self-reported, but now researchers can provide subjects with a wearable device to see how long they slept and approximately how well they slept, and they can start to validate everyday activities and vitals with these devices. This is where the more consumer-grade wearables are going to start to impact clinical trials, replacing or subsidizing what has traditionally been a lot of patient-reported information.
A: lot is in pilot phase. Oscar, a health insurance company in New York, is giving wearable trackers to their members, incentivizing them to be healthy. John Hancock, a life insurance company, has piloted giving wearable trackers to life insurance policy holders. If folks are moving or exercising a certain amount of time a month, the cost of their life insurance goes down. That type of thing is disrupting a model of underwriting that’s been in place for over 100 years. We’re still waiting to see that level of innovation in other areas of healthcare.
In the past year, we’ve seen incredible growth, especially in the clinical research space. We have a lot of new clients interested in looking at using this data for clinical trials—Medidata, Quintiles, Novo Nordisk and Amgen. A lot of phase I trials, as those don’t have to go through regulatory approval. At this point, they’re just using them to explore, to learn more about the patient population, while looking to what they might be able to do with phase II and III trials.
Q: How is the FDA reacting to the idea of wearable devices to gather data for clinical trials?
A: The FDA has historically said if a device is not Class-II listed, it’s not a medical device and therefore can’t be used in a clinical trial. If, for example, you’re studying arrhythmia, there are a variety of wearable trackers that provide heart rate information, but because of the variability from device to device, they have not been cleared by the FDA for this use. It’s an ongoing conversation. The FDA is in a challenging spot, with a limited number of reviewers and a lot of interest from medical and pharma spaces. I can say from my discussions with the FDA that they are very, very keen to allow and embrace the new technology as much they can, while guaranteeing the safety of Americans.
In clinical trials, the opportunity for this technology is to aid in the collection of data and help with the retention of subjects, all of which should lead to more efficient trials. With a wearable tracker, a person can be part of a trial while just going about their normal daily business. They can be pinged through an app on their smartphone and respond right there, wherever they are. They don’t need to have a separate device, to log in to a portal or try to remember what they had for breakfast.
Q: Five years from now, what will remote data gathering for trials look like? How about in 10 years?
A: In five years, every study will leverage wearable technology to capture data, especially in the early stages, because there is so much capturable with these sensors. There is a growing list: activity trackers; heart rate monitors; UV trackers to measure sunlight exposure, which can be useful for seasonal affect disorder and depression. There is also a lot of work being done on continuous blood pressure monitoring. There are so many sensors that capture so many things, I can’t imagine a world where pharma companies aren’t leveraging this to add information to their studies.
In 10 years, I think we may have configurable sensors for every trial. We’ll get to a point where it’s relatively straightforward for any technology company to swap out sensors on a device. Perhaps devices will have so many sensors built in, it will be easy to pick and choose specific configurations for each patient. It will get so easy to program that, theoretically from a dashboard, a few buttons could program devices and set up data collection.
This article was reprinted from Volume 20, Issue 03, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »