ResearchKit is making the clinical trial process a whole lot easier - and that's the first step toward achieving better clinical outcomes.
Apple's provider-facing, open-source platform, unveiled that past April, is being used in dozens of studies around the world, most of them focused on creating apps that allow providers to bridge the gap with at-risk, underserved and chronic care populations. At Duke University, researchers are studying whether an app targeted at children with mental health conditions can speed up and improve diagnosis, support continuing care and improve the lives of the children and their families.
To Ricky Bloomfield, MD, an assistant professor of internal medicine and pediatrics and director of mobile technology strategy at Duke Medicine, ResearchKit is a "huge step forward" for a process that's expensive, time-consuming and complicated, and one that often misses out on a significant population that could benefit. By enabling researchers to reach out to, basically, anyone with an iPhone, the clinical trial becomes much more effective.
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Speaking at a Monday morning session of the mHealth Summit, Bloomfield said the most important element of ResearchKit may be the Informed Consent tool, which distills "a piece of paper with thousands of words on it that are hard to understand" down to more manageable bits of information that a user can quickly and easily comprehend and sign.
"That simplifies the convoluted language," he said. "It's the one thing, I think, that makes it all work."
Bloomfield praised Apple for making the platform open-source, and said it would enable medical researchers to design effective studies with much more accurate outcomes. Apple has given the healthcare industry a framework on which to develop better trials, he said, and a tool by which those trials can reach out to a larger, more representative audience, rather than just relying on who's living close enough to the hospital or clinic to take part in the trial.
Bloomfield walked his audience through the development process for Duke's Autism & Beyond app, released roughly one month ago and now being tested for the feasibility of the technology.
His work isn't lacking in challenges. Linda Barry, MD, director of the Connecticut Institute for Clinical and Translational Science at the University of Connecticut, pointed out that ResearchKit currently only works for those with iPhones, which are expensive and not that prevalent in poorer, at-rick and underserved populations. "I know there are autistic children who do not have iPhones," she noted.
Bloomfield agreed, and said that's one of the reasons Apple made the platform open-source. He expects someone to develop an Android-based ResearchKit platform sooner or later, as well as a web-based app.
"The promise of this technology being able to reach so many people in need is exciting to me," he said, noting that more than 180 people signed up the first weekend after the study was launched even though it focuses on very narrow demographics (you must be a parent of a child between 1 and 6 years old).
Another promise of ResearchKit is that it will drastically reduce the cost of a clinical trial, which nowadays can soar above $100,000. Bloomfield said the costs are still prohibitive, but the open source platform should entice smaller health systems and entrepreneurs to work with what they have and can afford, and design something that works for them. He envisioned a ResearchKit trial someday that would cost no more than $15,000.
In the end, said, Bloomfield, it's all about potential. He envisions the Autism & Beyond app someday helping providers to diagnose problems much earlier in children – current estimates say that one in every nine children has some sort of mental health condition, that those issues can be detected as early as 18 months, and that the average age of a child diagnosed with autism or some similar disorder is 5.3.
