Thumbthing Writings by Bob Spryn, and Roderic Campbell, iOS Engineers and founders at Thumbworks

Making Clinical Trials Mobile

Mobile devices are revolutionizing every industry, one by one. The taxi industry, retail, even television are all being massively disrupted because that’s what consumers with smartphones are demanding.

In the next five years, smartphone ownership will go from 2B to 4B, and 80% of adults worldwide will have smartphones. The smartphone industry already dwarfs the PC industry - there will be 2-3x more smartphones than PCs in use in 2020. Smartphones have outpaced nearly any comparable technology in the leap to mainstream use.

Introducing ResearchKit

For medical research, it wasn’t a question of if, but when mobile disruption would happen. In April of 2015, Apple gave the medical research industry a big head start by introducing ResearchKit, an open source framework that allows researchers and developers to create powerful apps for medical research.

“Putting the solutions in the hands, literally the hand, with an iPhone, of the patient. This is the answer. This is exactly where medicine is going. It has to. It has to.”
- Kathryn Schmitz, PhD Penn Medicine

The open source model harnesses the power of distributed peer review and transparency to create high-quality, secure, and easily integrated software at an accelerated pace and lower cost.

As a medical researcher, you are primarily interested in one thing: data; measured, quantitative, objective, data. Unfortunately, methods for conducting medical research haven’t really changed in decades. Researchers end up spending far too much of their time doing the labor intensive task of collecting and qualifying the data.

Instead, imagine being able to distribute an app on site with your researchers, or even straight to your participants. An app that takes them all the way from informed consent, to collecting high quality survey and sensor data, to uploading well-structured data to a secure remote database, ready for your analysis. The places that mobile devices can take medical research and clinical trials to are breathtaking.

Let’s look at what ResearchKit is, and what it provides over current methods of data collection in clinical trials.

The Apple + Open Source Advantage

Apple has a track record of creating incredible products and astounding, easy- to-use apps. The open source software community has the advantage of thousands of developers contributing their best efforts and ideas for free to build something that a small team alone could not have created. This means better security, customizability, and quality. When you put those Apple and open source together, you get something pretty special.

ResearchKit was developed by designers and engineers at Apple to help medical research leapfrog it’s current state by light years, but they didn’t stop there. Apple open sourced the framework so all the best engineer minds are free to contribute to the software. Developers submit their additions, and Apple reviews them and integrates them into the software when they determine the code is sound.

The main components of ResearchKit

ResearchKit provides an impressive amount of capabilities out of the gate. It has four main components, each of which we will look at in detail in additional posts.

  1. Informed Consent - Take your physical informed consent document, and turn it into an interactive, easy to consume, series of visual informed consent steps in an app. This includes many predefined sections that are commonly found in consent documents, such as: data gathering, privacy, time commitment, withdrawal, etc. With ResearchKit you even have the capability of capturing the participant’s signature.

  2. Surveys - ResearchKit has a robust survey engine with predefined question and answer formats suitable for the majority of surveys and diaries required in a clinical trial. Custom question and answer formats can be created for any unique requirements. The predefined answer formats even include the ability to let the participant provide health data collected by the iPhone, Apple Watch, and other third party devices in the secure HealthKit repository, such as heart rate and calories.
    HealthKit is Apple’s framework used to collect, store, and secure personal health information on iOS devices. More on that in another post.

  3. Active Tasks - A truly special feature of ResearchKit and building a clinical study on a mobile device is the ability to instruct the participant to carry out active tasks while collecting sensor data from the phone. The framework comes with a predefined set of tasks built for some of the original research studies launched alongside ResearchKit, including a task to measure your gait while doing a walking task, a spatial memory task, and a sustained phonation task.

  4. Charts - A community addition, this component allows you to surface data in chart form to your researchers or participants where appropriate.

The advantages of using a mobile app built on ResearchKit

The advantages of using ResearchKit and a mobile app for clinical trial data collection are numerous, and we’ll only begin to scratch the surface here.

Data: Quality, Quantity, and Speed

It’s really all about the data, and that’s where collecting data with a mobile app built on ResearchKit really shines.

“We can now engage unprecedented numbers of individuals in large geographic areas, many of which who have never been able to participate in research.”
- Ray Dorsey, MD, University Of Rochester Medical Center

With Apple having sold nearly 1 billion iOS devices, the pool of potential participants that already have the necessary technology is extremely large. ResearchKit has already seen unprecedented success with many research studies. This solution can be realized for clinical trials today.

In our next post we’ll look at some additional possible possibilities and their benefits when building a clinical trial app.