Embedded in the splashy debut of the Apple Watch, was something that the clinical trials world will find pretty interesting. Apple introduced a new open source tool called ResearchKit. Along with academic partners, Apple developed and launched 5 clinical trial apps built with the ResearchKit tool. One of the apps introduced in the rollout is called "Share the Journey: Mind, Body and Wellnes after Breast Cancer." Developed at Dana-Farber, the app tracks the recovery path of breast cancer survivors. Instead of collecting data with paper surveys, study participants respond in real time to questions about changes in their daily mood, fatigue levels, and signs of cognitive difficulties. Another app, GlucoSuccess, allows diabetics to participate in a research study that gives feedback on how their diet and exercise patterns impact their daily glucose readings. I got all quivery with excitement, downloaded the 'MyHeart Counts' app, watched the embedded video (nicely done), clicked through the eligibility critieria, walked through the consent (a plain language beauty!), opted to share my data with only Stanford researchers, and agreed to participate. I received the complete consent form via email. I know how to contact the IRB or and I know how to leave the study. A lot of self-control was required to slow down and read all of the information. A big change from my normal behavior of rapidly clicking and downloading new apps. My participation will give me a prediction of my risk for future heart attack and stroke. And with my user reported data, they will never know if I reported my age and weight correctly.
On the one hand, there is a lot of excitement in the lay press about the opportunity to reach vast numbers of potential trial participants and potentially crack the slow-accrual problem. The Apple roll out video cites the example of sending out 60,000 letters to recruit 300 study participants. On the other hand, there are a number of issues that give us pause. All of the questions that you might expect are appearing in media posts about ResearchKit-- about issues like confidentiality, de-identification of data, data security, identify verification, and the process for obtaining informed consent.
I've been on the MyHeart Counts study for 3 days and here's the deal. I have a couple of small questions. No big deal, but there doesn't seem to be a way to get them answered. Short of calling the phone number for the Stanford IRB. As excited as I was to dive in to the latest cool thing, I must say that I do miss the interaction that meeting with study personnel would provide. Or maybe a virtual community for study participants. I bet one of them could answer my question. We'll see how it goes.
In the meantime, the Parkinson's app enrolled 7406 people in 6 hours. Wow!
What do you think about this new approach? Will you give it a try?