Breakthrough Patient Recruitment

: ResearchKit Enrolls Thousands in Clinical Trials: What Next?

ResearchKit Enrolls Thousands in Clinical Trials: What Next?

Senior Art Director

Technology plays a large part in patient recruitment and tracking for clinical trials. Apple's new initiative called ResearchKit is offering researchers a new tool to collect and share information. Although this tool is new to the market, a Stanford University study has already used ResearchKit and was able to enroll more than 10,000 people in less than 24 hours. While the initial numbers are staggering for anyone who has worked to recruit patients for a clinical trial, we have to keep in mind that there are--and will continue to be--issues with any new use of technology.

How does it work?

ResearchKit is an integration app on the iPhone to help with medical research by allowing researchers to aggregate data by using a device many people already have in their pocket. The app grants researchers access to a large pool of potential participants and the tools to help them collect data. An iPhone has sensors that can track a variety of activities and the processing power to make that data useful for the researcher. Because of the built in sensors on the phone, a number of tests can be performed in a non-subjective manner. In turn, the phone becomes a powerful tool for collecting participant self-reported data.

 

"To get 10,000 people enrolled in a medical study normally, it would take a year and 50 medical centers around the country,"Alan Yeung, medical director of Stanford Cardiovascular Health,  told Bloomberg. "That's the power of the phone."

 

Stanford isn't the only one using this technology. The University of Rochester and Sage Bionetworks have a program called mPower, which helps patients with Parkinson's disease gather motion data such as dexterity and balance. This data is gathered using an iOS device, so it's not as subjective as it would be if it was collected by different groups of people at a clinical center.

Meanwhile, Mount Sinai, Weill Cornell Medical College, and LifeMap have a program called Asthma Health. This program allows the Asthma Health study to track locations where asthma attacks happen and can also help participants avoid areas where there are environmental factors that could adversely affect their condition. One of the features of this system is that it can provide feedback as a reward for participation, so while you're helping others, you are actively helping yourself.

What about consent?

Obtaining consent is a critical part of the clinical trial process. Currently, the process for gaining consent through the ResearchKit takes place via a series of questions included in the app. However, there remains a chance that people may misidentify themselves, and provide false data. Given the sheer number of people who have already signed up to participate in ResearchKit, the hope is that any false or inaccurate data won't have a large effect on the final data from these studies. It may be an ongoing issue, but I think some standards will emerge as this technology use evolves.

Apple has also taken steps to ensure that personal privacy is protected when people use ResearchKit by keeping the user in control of what data he or she shares. Apple will not see any participant's data. Companies like Sage Bionetworks process data before it is sent to the study to make sure that no identifiable information is sent to the researchers. 

ResearchKit could become an invaluable tool for researchers to gather information that would have never before been available. The program is open source, so all developers will be able to work with it to create programs that can truly improve health and drive behavior change.

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