By Ann Neuer   

February 17, 2015 | As clinical trials become more patient-centric, Medidata sees the next horizon for collecting clinical trial data as the patient’s own wearable device. A variety of objective measures, such as hours of sleep, number of steps taken, and distance traveled can be detected through a mobile health (mHealth) watch-like device. In support of this effort, Medidata has just announced a new collaboration with Garmin International to use its mHealth wristband—the vivofit—in clinical studies.

The vivofit is an activity tracker that monitors human rest and activity cycles. It is water-resistant, weighs less than one ounce, and has a one year battery life. The clinical trial data it collects is integrated with the Medidata Clinical Cloud repository that includes information such as vitals, medical histories, laboratories, and adverse events. Clinical data are pulled from the vivofit wirelessly in 15-minute increments and then analyzed to evaluate its link to traditional clinical measures and determine whether these data can provide sharper insight into patient health status or response to therapy.

“We are really excited about wearables because they measure objective data, which is always better than subjective data. We got involved because there are certain kinds of data that have been either difficult or impossible to get from an objective perspective without bringing a person into the clinic. Also, the idea that you have to measure all data points in the clinic is out of date,” says Glen de Vries, President of Medidata.

Hours of sleep in a clinical trial is one example of an objective endpoint that can be very difficult to measure in clinical trials as patients may be asked to record this information at home, yet it is recognized as less than reliable. Being able to measure hours of sleep objectively using vivofit could be an important surrogate endpoint, and provide additional insight into the overall value of an investigational medication, including impact on quality of life.

Given that wearables allow objective data to be collected from patients in their day-to-day lives, their use may eventually lead to significant changes in how protocols are structured. This may result in fewer study visits as well as changes in the type of data collected at study visits since more data will be collected objectively through wearables. (See, Digital Utopia, Meet the Null Hypothesis) According to de Vries, “We may see lots more data, a magical garden of data, as well as new statistical methods to better determine effectiveness of study drugs.”

But, at the risk of sounding too futuristic, de Vries cautions that much very hard work still needs to be done to scientifically evaluate the real impact of wearables on clinical trial data. Fortunately, he notes that a cadre of forward-thinking sponsors are interested in propelling this idea forward, not only to move away from old subjective endpoints but also to document competitive advantage for their investigative drugs or devices. “It’s a race as to how you can present the overall advantage of your drug in a competitive marketplace. The smart companies will be the ones to define what it means to be progressive,” de Vries notes.

To document the value of this approach, Medidata is functioning as a sponsor in a study looking to create clinical trial process innovation. In particular, the study explores whether mHealth tools, namely activity trackers; Medidata Patient Cloud, an electronic patient reported outcomes (ePRO) mobile app; and text messages on nutrition and exercise can increase the rates of therapy adoption and drive better health outcomes for people with Type-2 diabetes. The study is expected to conclude later in 2015, and results will be analyzed to determine whether the data collected make sense from a clinical perspective and add therapeutic value. Results will be publicized, and the company hopes they will show regulators that mHealth offers a compelling data opportunity.

In the interim, the initiative with Garmin has been launched, and although Medidata cannot comment on specific studies, de Vries mentions that a number of drug trials using the vivofit tracker will be starting throughout 2015.

“There will be more and more connected patients, and companies are embracing the technology in their development cycle. Our goal at Medidata is to make it possible to integrate these measurements with traditional data points. This will allow us to have a more holistic view of the patient than we have ever had. We hope to be able to help our clients use this information to learn something new about a patient,” de Vries explains.