Dubbed a “clinical trial in your pocket”, Apple’s new open source framework for clinical research (called ResearchKit) makes it easy for hundreds of millions of iPhone users around the world to participate in clinical trials. By simply downloading an app and agreeing to share their anonymized health data with research institutions, iPhone users can contribute to groundbreaking studies. With the user’s permission, ResearchKit can access the iPhone’s native sensors and integrate with third party apps and wearable devices in order to track measures like pulse, blood pressure, glucose levels, and asthma inhaler use. Apple launched the new platform along with the first five ResearchKit apps last month, and recently opened the doors to the ResearchKit framework so that any qualified researcher may develop and deploy a study on the platform. By reducing barriers for both participants and researchers, ResearchKit is a welcome development in the clinical landscape.
The first five apps launched with ResearchKit
More Subjects, More Frequent Data, Lower Cost
ResearchKit represents a transformation within clinical research by providing patient-generated real-world data on a massive scale for minimal cost. With ResearchKit, instead of collecting data from 100 subjects, researchers will collect data from 100,000. Instead of collecting data from subjects every 3 months, they will collect data every 3 hours. And instead of spending millions on recruitment, data entry, and monitoring, they will spend just thousands to develop an app.
So far, ResearchKit has lived up to the hype. Using ResearchKit, Stanford Medicine was able to recruit 10,000 participants in less than 24 hours for their cardiology study. Similarly, the University of Rochester recruited 8,000 participants in a week for their study on Parkinson’s disease, drastically surpassing the previous Parkinson’s study enrollment record of 1,700 participants. In an industry in which 15-20% of studies fail to enroll a single subject, these results are truly incredible.
“To get 10,000 people enrolled in a medical study normally, it would take a year and 50 medical centers around the country,” said Alan Yeung, medical director of Stanford Cardiovascular Health. “That’s the power of the phone.”
More data means a better understanding of health and disease. As Dr. Eduardo Sanchez of the American Heart Association says,
“Numbers are everything. The more people who contribute their data, the bigger the numbers, the truer the representation of a population, and the more powerful the results. A research platform that allows large amounts of data to be collected and shared — that can only be a positive thing for medical research.”
Despite widespread enthusiasm, many industry experts have expressed concern about ResearchKit from ethical and scientific standpoints. One major criticism is that it is impossible to know for sure if participants meet the inclusion/exclusion criteria of a study. In at least three of the five original apps, it’s easy to lie on the initial screening questions to fake eligibility. For example, in the Asthma Health app developed by the Icahn School of Medicine, if a user enters that they are under age 18, the app disqualifies them from the study. But, the same user can easily return to the previous page, answer yes, and suddenly become eligible. In person, it’s easy to verify age by requiring a photo ID, but online it’s next to impossible. Given that minors have special research protections and are usually required to provide parental consent before participating in research, the inability to accurately verify age in ResearchKit is highly problematic according to some research ethics specialists.
In addition to eligibility fraud, critics point out challenges with providing sufficient informed consent remotely and ensuring that data is rid of all protected health information. Some critics also question whether the population of iPhone users is too biased toward white, upper middle class populations. That said, all five of the ResearchKit apps were approved by the Institutional Review Board (IRB). It’s not clear, however, whether Apple will require IRB approval for all future studies in ResearchKit.
For more information on all the ethical issues associated with ResearchKit check out The Verge’s article written by Arielle Duhaime-Ross.
The Parkinson mPower app precisely measures data such as dexterity, balance, memory, and gait. This information can help researchers understand the wide variability in Parkinson’s disease symptoms that has puzzled experts for decades.
Not Enough for FDA Approval…Yet
One of the benefits of ResearchKit is that it provides researchers with data collected at regular intervals throughout a patient’s day in the real world. However, the FDA obviously can’t approve new drugs based on patient-reported data alone; Phase I-III trials must still employ highly controlled designs such that researchers can isolate the effects of a single variable independent of outside forces. However, ResearchKit may be useful for providing patient-reported outcomes in order to support labeling claims once a drug is approved. For now, ResearchKit will yield the greatest benefits in post-marketing trials, observational studies, investigator-initiated academic studies, and epidemiological and preventive studies on a global scale.
The Future: Quantified Selves Cure Disease
Clinical researchers have been discussing mobile data collection and big data analytics for years, and Apple’s ResearchKit is a major step forward in a larger transformation. In the short run, ResearchKit will improve efficiency for certain types clinical research, but the real gains from the platform will come when it is paired with other technologies that are on the way.
Personalized health technologies are rapidly making complex health information cheaper and more accessible. For example, the company Cue provides a low cost saliva and blood testing kit that integrates directly with an app and 23andMe now offers partial genome sequencing for as little as $99. Paired with ResearchKit, precise data like these will give investigators a much fuller picture of exactly what is happening inside our bodies.
At Medrio, we’re excited about the future of clinical research and eager to provide our customers with modern tools that make data collection simpler, faster, and more affordable.