How New Apple System May Change Clinical Trial Management

How New Apple System May Change Clinical Trial Management

Researcher Kathryn Schmitz's 'Share the Journey' App

Speaking in a CNBC TV interview, the University of Pennsylvania School of Medicine's Kathryn Schmitz emphasized the potentially revolutionary impact of Apple's new ResearchKit system on health services researchers' clinical trial projects.

University of Pennsylvania Professor of Epidem-
iology and LDI Senior Fellow Kathryn Schmitz
appeared on CNBC to discuss her development
work on an app for Apple's new ResearchKit
product.

ResearchKit is one of several new Apple products designed to work with the wearable biometrics monitoring systems built into both the latest iPhones and the company's new Apple Watch. ResearchKit is a centralized data infrastructure that enables research teams to design and operate apps that can efficiently collect, process and analyze daily biometric data from research subjects.

Clinical trial apps
The newly-launched ResearchKit contains five different apps for specific clinical trial areas including post-breast cancer treatment symptoms, asthma, Parkinson's, glucose levels, and risk factors for cardiovascular disease.

Schmitz, PhD, MPH, a Professor of Epidemiology at Perelman School of Medicine and a Senior Fellow at Penn's Leonard Davis Institute of Health Economics (LDI), is one of a four-member team who worked with Apple to create the new post-breast cancer treatment symptoms app called Share the Journey. The other three members were Patricia Ganz, MD, of UCLA's Comprehensive Cancer Center; Ann Partridge, MD, MPH, of the Dana-Farber Cancer Institute and the Harvard Medical School; and Stephen Friend, MD, PhD, of Sage Bionetworks, a non-profit research center in Seattle.

The launch of the 'Health' app whose name
was later changed to 'HealthBook' was the
start of Apple's aggressive move into the
mobile health monitoring market.

The app, which has a webpage  recruiting its first round of clinical trial participants, is designed to study the post-treatment symptoms of breast cancer, how they vary over time, and what can be Done to address them more effectively to improve the life of breast cancer patients.

Order of magnitude
The real game-changing feature of ResearchKit, Schmitz told CNBC, "is our ability to recruit in the order of magnitude of thousands and tens of thousands compared to the past when we've only been able to recruit in the tens and hundreds."

Much the same way it transformed whole sections of the computer industry and the mobile phone industry, Apple is now executing a broad product strategy aimed at creating a continent-spanning system of wearable biometric monitoring devices linked to central health care data systems.

A year ago, the company launched HealthBook, the biometric gathering app and health data management "dashboard" that is now installed on every new iPhone.

A second new product was HealthKit, a suite of infrastructure tools that enable app engineers to design and build health-related apps that interface with the HealthBook dashboard

ResearchKit apps can function has a comprehen-
sive iPhone system for recruiting clinical trial
participants, handling their administrative
forms, gathering their data and otherwide
interacting with them in a real-time way.

And this has now given rise to the third product, ResearchKit, which is a data system designed to support the use of HealthKit-based apps by researchers conducting clinical trials in a wide range of health-related fields.

Apple Watch sensors
Meanwhile, the new Apple Watch, due for launch next month, is reported to be a sophisticated skin-hugging device that includes more than 10 sensors for tracking and streaming biometric data to HealthBook apps.

The overall Apple system creates a potentially vast integrated biometrics gathering matrix reaching across a population of hundreds of millions of iPhone owners.

"The real news here for us," said Schmitz, "is about the platform and the fact that researchers will be able to collaborate with Sage Bionetworks and ResearchKit to build apps to track whatever they want to track in breast cancer survivors. That's the promise and what is really exciting."

She noted that the team with the ResearchKit Parkinson's app (of which she's not a member) "got over 2,000 research participants in a very short time frame."

HealthKit is a tool infrastructure that enables
software engineers to build custom applications
for the Apple iPhone's HealthBook and
ReseachKit biometric-monitoring systems.

Schmitz explained that ResearchKit/iPhone/Apple Watch bio tracking systems potentially give researchers numerical as well as photo, video, audio and accelerometric data from their study subjects. For instance, among the information points that will be collected by the Share the Journey iPhone app is how much a patient physically moves in a given day -- data generated by the same iPhone accelerometer that counts your steps.

Increasing sophistication
"With the advent of the Apple Watch, I don't think its very far away for us to have a system that monitors blood pressure, glucose levels, blood alcohol levels, and stress level," said Schmitz.

CNBC host Carl Quintanilla asked Schmitz if researchers and their analytical systems weren't in danger of being overwhelmed by the enormous amounts of data streaming in daily from huge cohorts of clinical trial subjects.

"This isn't our first rodeo," Schmitz said. "People who have been working in the accelerometry field have been dealing with massive data sets for decades. We know how to do this. We alrady have the software and the engineers who know how to parse out and understand large volumes of data. This is not going to be a problem."

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Hoag Levins is Editor of Digital Publications at the University of Pennsylvania's Leonard Davis Institute of Health Economics (LDI).