- Last month, Apple launched ResearchKit, a software framework that allows developers to use the iPhone as a diagnostic tool for medical research. It launched with five applications to study asthma, breast cancer, cardiovascular disease, diabetes and Parkinson’s disease.
Previously, mHealthIntelligence.com spoke with Corey Bridges, the CEO of LifeMap Solutions, the company that developed the asthma app. Now, we sit down with Yu-Feng Yvonne Chan, the director of personalized medicine and digital health, an assistant professor of genetics and genomic sciences and emergency medicine at Mount Sinai. She was also part of the team that created the study that the new application uses to gather information.
mHealthIntelligence.com: What was the process like working with ResearchKit?
Yvonne Chan: The greatest change and most innovative aspect of this project is the ability to consent patients with the e-consent method. In the old ways we would have a patient come to a large academic centers where the research would actually be conducted and you need a medical professional or research personnel who is capable of obtaining medical consent would need to physically meet with the individual, explain the process and get signatures on paper.
ResearchKit and the e-consent process allows us to essentially work remotely, everything from recruitment through the app store, consent from the app itself, answering questionnaires. It is all done remotely from beginning to end. At no point does the researching interact directly with the participants.
MHI.com: What there any unique challenges when it came to designing the challenges?
YC: Part of the process that we needed to be mindful of was obtaining the informed consent. There was a very thoughtful and careful process that was generated by our Institutional Review Board to make sure that to the best of our knowledge, the participants knows the risks of participating in the study.
Through discussions and and experts in clinical research, we created the best solution we could in terms of the consent. We offer a digital copy of the written consent form for the patient to review. There are then several questions prospective patients can answer to ensure they understand the risks and there is an optional video as well that that covers the study and the steps the research will take. All of these components were needed collectively in the consent process.
MHI.com: How long did you work on it and how does that compare to other studies not on the ?
YC: I would say I started working in earnest at the end of August or the beginning of September through the announcements in March.
We probably dragged it out a bit longer because we had a specific launch date. We were motivated to put in the extra hours beyond the call of duty just to make sure we would hit the deadline. Also, because of the innovative process, the review process took longer than what a more traditional project review process would have taken.
Beyond that, the impact of being able to recruit through the app store, the wait in recruitment is unprecedented as far as I know.
MHI.com: What has the reception been so far?
YC: Of the five launch apps, we have the most stringent inclusion criteria, which meant we were not able to take everyone we wanted. Despite that we had [35,000 downloads in the first four days and 4,061 people consented and enrolled as active participants].
These are pretty staggering numbers as far as clinical research is concerned. Beyond the sheer large sample size, we are also canvassing a large geographical region. Essentially, anyone in the US that meets our criteria and has an iPhone and internet connectivity can be a participant.
In traditional studies, participants need to have proximity to where the consenting process takes place, causing the results to be very localized. There is a chance that a clinic might have multiple locations, but it is not this large in scope. That is really exciting for so many reasons. We get such a better sampling across the land.
MHI.com: Did you have any expectation that the download number would be like this before you launched or were you as surprised as the rest of us?
YC: I would say cautiously optimistic. We really didn’t know. This was unprecedented. We thought the numbers would be on the large side but not like this. The overall responses from the public and the academic community has been overall positive, which has been very wonderful.
MHI.com: How will this change the way you do medical research going forward?
YC: Just because of the attention that medical research is receiving from this, the public awareness is growing and shading toward the general population. This could pave the way for more clinical research to use this platform down the road. While there are going to be some studies that can’t use mobile devices, this is a very important step in a new direction.