With Apple’s release of ResearchKit, we were super enthusiastic that such a large company would take such a positive stance on clinical trials technology. As a company that works hand in hand with clinical trials researchers, we took the time to review what ResearchKit has to offer. We’re really excited about some of the innovation the open-source platform comes out with, and especially integrating those into our own platform. While a positive step towards making mobile devices ubiquitous in clinical trials, Apple is still far behind the curve in a lot of aspects.
ResearchKit is not an app, it is an SDK. SDK stands for Software Development Kit, which allows for the integration of frameworks or applications into your software. What this means is that the researcher must still build or commission their own app, a costly undertaking and not for the faint of heart in the healthcare field. An SDK is great for companies or individuals already committed to building health research related applications, but may be limiting to researchers without coding experience who want to leverage these tools.
MetricWire has built proprietary software for clinical trials that gives researchers the ability to highly customize their study designs, as well as work with their data. We’ve outlined some of the limiting and costly factors associated with using an SDK, and show how MetricWire has already taken these factors into consideration, and built our own proprietary solutions.
ResearchKit does not support Android Devices or Tablets
Right off the bat this is a huge con. ResearchKit only runs with iOS 8 limiting its functionality to newer iPhones, and not devices running iOS 7 or tablet devices. Additionally, in a market where Android now has a global dominance of ~80% market share, this is a very limiting factor.
MetricWire supports iOS 7 and Android 4.1 as a minimum, as well as supporting tablet devices and iPods. We have also found an overwhelming number of devices in our researchers’ studies are in fact Android devices.
No Scheduling Features or GPS
The SDK does not have the ability to send custom push notifications/schedule tasks for your participants. In a clinical setting, this is not helpful since you cannot send interventions to patients based on responses. The SDK does not use passive sensors like GPS as well, so things like geolocation and geofencing aren’t being supported.
For ResearchKit to become a better platform for the clinical setting, developers need to build in robust scheduling and intervention tools. MetricWire has built the most advanced push notification system for the smartphone data collection industry. Using features like random and daily triggers, as well as the ability to set custom time and date ranges, clinical researchers can easily schedule notifications and prompt patients in-the-moment. In addition to time-based notifications, MetricWire also has the ability to create virtual boundaries that prompt participants with a survey when they enter a building or specific area.
ResearchKit does not Offer Security and is not HIPAA compliant.
Apple’s SDK cannot guarantee the security of the data that is transferred from your patients to your servers. Apple leaves it is up to the researcher to ensure that what they are building matching governing laws and compliance. This is a massive undertaking and costly if you have no prior experience working with servers and compliance regulations. Additionally, app developers not familiar with the healthcare space this can be a pain trying to understand the regulations, or working with another SDK for compliance like TrueVault.
Working in healthcare and clinical trials, we’ve taken the proper steps to ensure that our platform technology, as well as our procedures, match compliance guidelines. We’ve done the necessary work to ensure that our platform is compliant and ready to use right away when a researcher needs to conduct a study.
You Need to Build Your Own Analytics Platform
ResearchKit can’t guarantee what your data will look like when you get it. In order to work with your data, you must spend time developing a workable back-end that will format your data properly, allowing you to download it or work with it online. Again this goes back to time and money. If the raw data isn’t formatted correctly or tagged and labeled properly, it becomes tainted and unusable.
We’ve built an incredible analytics platform that allows researchers to not only download properly formatted raw data, but organize and edit online, as well as create custom charts and visualizations.
While ResearchKit provides an excellent resource for adding new thought and technology into the clinical trials, it is still going to be an expensive alternative to using existing solutions. Researchers with a limited budget and time-frame cannot afford to spend tens of thousands of dollars and months of work on developing their own apps and back-end platforms. Solutions like MetricWire are built to help these researchers who want a highly customizable tool kit right out of the box, without the hassle of new app development. We’re really looking forward to seeing what innovation comes out of the open-source SDK, and integrating that with our own tools.