GlaxoSmithKline ($GSK) has taken the plunge and set up a clinical trial running on Apple’s ($AAPL) ResearchKit framework. The study will enroll and evaluate 300 rheumatoid arthritis patients through an app that runs on iPhones, freeing GSK from the need to activate trial sites while giving it access to sensors with the potential to measure wrist movement.
GSK, in collaboration with its technology partners Medidata ($MDSO) and POSSIBLE Mobile, has built the app to track common symptoms of rheumatoid arthritis such as joint pain and fatigue. The app gathers these data using a mix of surveys and sensor-enabled tests. Through the survey questions, GSK will collect information on how long participants feel joint stiffness in the morning and other metrics. In parallel, GSK is using iPhone sensors to record motion during wrist exercises.
The trial isn’t assessing the safety or efficacy of an experimental drug. Instead, GSK is using it to gather real-world data on the day-to-day lives of people with rheumatoid arthritis and, perhaps most importantly, insights into how it can build ResearchKit into future clinical trials. While the first-wave of ResearchKit apps quickly clocked up enormous enrollment figures, subsequent analyses suggested many users stopped contributing data after just a few days. GSK will need its app to deliver a better retention rate if it is to become a launchpad for more widespread use of ResearchKit.
“One thing we’ll learn is whether we made it compelling enough to make you want to interact with it every day,” Rob DiCicco, head of clinical innovation and digital platforms at GSK, told Bloomberg. If the trial is a success, GSK could start using ResearchKit as a bolt-on data collection tool in other trials, giving it a way to gather additional information that could inform its future research initiatives or demonstrate the real-world impact of a drug to payors. Others have considered using ResearchKit as a recruitment tool for traditional trials. In this model, the app acts as another source of potential participants who enter the traditional screening process after an initial virtual assessment.
While ResearchKit has generated plenty of interest across the industry, GSK is claiming to be the first drugmaker to use it to run a study. GSK revealed itself to be at the forefront of adoption of the tool last summer, at which time it said it was aiming to start a ResearchKit-run study in the “coming months.” Ultimately, it took GSK 12 months from that statement to get the study, dubbed Patient Rheumatoid Arthritis Data from the Real World (PARADE), up and running. If PARADE is a success, other drugmakers could step up their interest in ResearchKit.
In isolation, the trial is testament to both how far clinical trial technology has advanced in recent years and how far ResearchKit is from being part of the mainstream clinical trial toolkit. When Pfizer ($PFE) designed a virtual clinical trial in 2011, it used a patchwork of technologies to carry out the enrollment and evaluation of participants. Today, GSK can do everything through an iPhone. And yet, the much-discussed limitations of ResearchKit--such as the bias introduced by limiting enrollment to people who own an iPhone--and other factors mean virtual trials remain a niche pursuit.
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