How Apple’s ResearchKit Could Support Device Makers in Conducting Clinical Trials

By Thomas Klein

“It is already happening to a large degree,” Greg Caressi, senior vice president, healthcare and life sciences, for Frost & Sullivan, told European Medical Device Technology. “Device makers are creating products that can be used by consumers in their homes to support remote monitoring applications.”

ResearchKit is used with Apple’s iPhone for access to an individual’s health data in real time, such as weight, blood pressure, glucose levels, and asthma inhaler use. ResearchKit can also access the iPhone’s accelerometer, microphone, gyroscope, and GPS sensors to gain insight into a patient’s gait, motor impairment, fitness, speech, and memory to test and monitor diseases such as Parkinson’s.

The main feature of ResearchKit is to support companies to carry out clinical trials and healthcare professionals to collect information on a much larger and more efficient scale from individuals on a daily basis than they could in the past, Caressi said. “Rather than filling out paper forms, or showing up at the research center once a week, month, etc. individuals that are part of the subject pool for a trial can report information electronically via their own device,” Caressi said. “This will enable collection of more frequent (and theoretically more accurate) data to support research by pharma and medical device companies, as well as academic medical centers.  Remote monitoring devices that might be used to check a patient’s biometrics can automatically be uploaded and transmitted to researchers for people involved in trials, which creates better data than patient entered logs often used in trials, or less frequent readings taken in clinical settings when patients come in.”

Apple is just beginning to form partnerships with research organizations, which already include American Heart Association, ULCL Jonsson Cancer Center, Weill Cornell Medical College in conjunction with to Mount Sinai in N.Y., , and other academic medical centers, while numerous other research partners and private firms will likely use ResearchKit in the future, Caressi said.

However, a potential drawback is that despite the several hundred million iPhone users who could potentially use ResearchKit, they do not necessarily form a sufficiently diverse demographic group for research purposes. “Drawbacks are the requirement to use an Apple smart phone or tablet, which limits the patient pool,” Caressi said. “However, the possibility of skewing results to a less diverse set of users is offset by the wider pool of subjects you can now draw on, however.  Eventually, these tools could be used to both recruit individuals into trials more rapidly and to expand the reach of trials to those outside of limited geographic areas where patients are near research centers (big hurdles and costs in running trials), as well as in collecting better data and more frequent data that will help understand trial results sooner and with more accuracy.”


Josh Sandberg

Josh Sandberg is the President and CEO of Ortho Spine Partners and sits on several company and industry related Boards. He also is the Creator and Editor of OrthoSpineNews.

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