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Smartphone app revolutionizes clinical trial consent and data sharing

Monday, March 14, 2016

Sage Bionetworks, a Seattle-based nonprofit, has released the first six months of data from a new iPhone app that captures the everyday experiences of more than 9,500 study participants. The app, called mPower (Mobile Parkinson’s Observatory for Worldwide, Evidence-based Research), manages and simplifies the research study, from patient recruitment through the enrollment and consent process. It also enables researchers to collect extensive data from patients with and without Parkinson’s disease. Data from the study can be used to assess the ability of mobile apps to improve the paradigm for clinical studies.

Sage developed mPower using Apple’s mHealth ResearchKit for iPhone apps. This open-source framework was launched in March 2015 so that developers and researchers could create simple, cost-effective apps for medical research. The premise was that, by making it easier for people to participate in these studies, it would also be easier and more cost-effective to conduct the research. Development of mPower was funded largely by the Robert Wood Johnson Foundation.

Leading industry spokespeople have expressed support for the ResearchKit approach. James Beck, Ph.D., vice president of Scientific Affairs at the Parkinson’s Disease Foundation (PDF) is enthusiastic about using the coded data shared by participants: “It’s important to learn directly from the people who are living with the disease 24/7. They are smart people, and they’re willing to share their personal data in order to move forward faster.” Michael Pencina, Ph.D., director of Biostatistics, Center for Predictive Medicine at Duke Clinical Research Institute (DCRI), observed, “It’s amazing how many subjects you get that would otherwise not be included. It’s a huge pool, far exceeding the typical population of earlier studies.”

Because of its design and execution, the mPower study is one of the first observational assessments of human health to rapidly achieve scale. The study design upends many previous barriers to sharing clinical data and insights. For instance, the enrollment and consent process was largely reinvented. Instead of sending thousands of letters inviting participants to take part in the study, a user-friendly Web page invites prospects to become research partners in order to make a difference in the study. In simple, direct language, the page explains the purpose of the study, how it works, who is eligible to participate, and the tasks required of each participant. A five-step graphic captures each step of the process and invites the reader to begin by downloading the free iPhone app.

Data released earlier this month revealed that more than 12,000 participants self-enrolled; more than 75% of them continued to use the app regularly to perform simple mobility tasks and to answer questions about their health, medication schedule (if any) and experience with the required tasks. The smartphone was used to collect both their answers and sensor-based data from the mobility tests.

Specifically, the study collected data on capacities affected by Parkinson’s disease, including dexterity, balance and gait, memory and certain vocal characteristics. For example, to measure dexterity, participants complete a speed tapping exercise on their iPhone’s touchscreen. To evaluate speech, participants use the iPhone’s microphone to record themselves pronouncing a vowel—saying Aaaaah—for 10 seconds. The app also allows participants to track when each task is completed and record when they take any medication to help determine the effects of that medicine on symptoms. Participants complete regular surveys, to rate the severity of symptoms and note what they think makes them better or worse.

Margaret Anderson, executive director at FasterCures, a D.C.-based center of the Milken Institute, said, “We have been watching the emergence of participant-centric research closely at FasterCures. Sage has placed research participants right in the middle of their studies, and given them the chance not just to be part of the research but to be in the driver’s seat.”
From its preliminary analysis of the data, Sage has found an enormous variation of symptoms within individuals, which could help researchers better pinpoint windows of intervention. Sage has also noted distinct patterns between medication intake and symptoms, insights that could eventually inform care and treatment regimes. By opening up the data and making it available to all researchers, Sage hopes to accelerate new insights that can be implemented in the clinic and lead to improvements in the lives of people with Parkinson’s disease—insights that can only be realized with a large, open community of data scientists analyzing and re-analyzing the data.

“The breadth and richness of this data demand that it not be shut away,” said Stephen Friend, M.D., Ph.D. and president, co-founder and director of Sage Bionetworks. “By releasing this data widely, we hope to seed a community of researchers working collaboratively to unlock the knowledge within and make new insights that help us begin to fully understand the lived experience of someone with Parkinson’s.” The concept is to create a new form of extended research community—a research commons, which promotes an ecosystem where research is conducted to provide data for others to consume in secondary research.

Duke’s Pencina is also passionate about collaborative research. “As a biostatician, I am excited about the possibilities that will occur when we apply novel techniques such as machine learning and new forms of data analysis to a continuous stream of collected data.”

Industry leaders acknowledge that new controls are needed. For example, Pencina cautions that the research community will need to ensure that those who access the data understand it. Stephen Friend and John Wilbanks, chief commons officer at Sage, have recently published an article in the journal Nature Biotechnology to emphasize that the mPower design includes a process to qualify additional researchers to access authorized participant data. Researchers can apply for access via Synapse, an online data and analysis sharing platform that is available on the Sage mPower Public Researcher Portal.

Calling the study “a sea change in participant control of data sharing,” Friend said that, while completing the consent form, “an overwhelming number of mPower participants have chosen to donate their data to science. Now science must do its part. As researchers, we must step up to the plate to make sense of all this data and translate it into real change in the lives of people suffering from Parkinson’s.”


By Joeth Barlas

This article was reprinted from Volume 20, Issue 10, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »

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