ResearchKit-enabled project sets out to track real-world effectiveness of hep C drugs

When Gilead's ($GILD) Sovaldi and AbbVie's ($ABBV) Viekira Pak came to market, physicians had little real-world evidence for either drug on which to base their prescribing decisions. In an attempt to fill this gap and find out what happens to hepatitis C patients between physician visits, Boston Children's Hospital has created an app for Apple ($AAPL) ResearchKit.

The iPhone app, C Tracker, pushes quick surveys to participants every two weeks and more thorough questionnaires every four months. Through these forms, the research team will learn the weight and height of the participant, which drug they are taking and how many hours of work they missed that week because of hepatitis C symptoms. The app also taps into the iPhone's sensors to gather data on the activity levels of each participant and the amount of time they are sedentary. Collectively, the two data sources are intended to provide insights into how people are responding to treatments.

While it is far too early to gauge the impact of the app, its creation is indicative of a willingness among organizations that buy and prescribe drugs to do their own research into whether treatments work in the real world. ResearchKit provides a new, large-scale way of running such studies. "By and large, the data we have now about hepatitis C treatments come from traditional clinical trials," Ken Mandl, principal investigator of the C Tracker project, said in a statement. "With C Tracker, we can listen to the patient voice to learn how people live with hepatitis in the real world."

Data generated in the study will come with the same caveats that apply to other ResearchKit-based studies--many of which relate to the bias of only enrolling people with Apple devices--but it could still throw up some interesting observations. If, for example, people who take Sovaldi were shown to have fewer hours off work than those on Viekira Pak, or vice versa, the study could have implications for the hepatitis C market. The organizers of the study plan to publish their findings in journals and at conferences. 

- read the release

BD&L Summit

Deal-Making Insights for the Life Sciences Industry

Bringing together key deal-makers and serving as an open forum for cross-functional business development and legal teams to share valuable insights and actionable strategies on successfully managing alliances, licensing agreements, and M&A deals.