STEVEN DeMello, like many people, uses a smartphone to keep a calendar, take notes, create artful photographs and listen to music. Recently, he began using it for a new purpose: to participate in a clinical trial.
Three times a day, the retired healthcare executive, who is 60 years old and has Parkinson’s disease, performs four tests using an app on his iPhone that records his results and provides feedback to researchers — and to him — on how his Parkinson’s symptoms affect his daily life.
"If I know more about my condition, the better and smarter I will be in managing my own care," he says. The app, called mPower, is one of five disease-related apps for clinical trials released in March in connection with Apple’s introduction of ResearchKit, a platform where users can track personal health data and participate in health studies. Other apps include My Heart Counts for cardiovascular disease, Asthma Health, GlucoSuccess for diabetes, and Share the Journey for a study of the aftereffects of treatment for breast cancer.
Together the apps — and patients like Mr DeMello — offer a glimpse of how the ubiquitous smartphone has the potential to transform medical research. Taking advantage of smartphone features such as accelerometers, gyroscopes and GPS locators, the apps track real-time daily activity and supplement other information on a patient’s condition.
Since the apps were launched on March 9, about 60,000 patients have enrolled in five studies just by downloading the apps from the app store, answering a few questions about the disease and clicking through a consent form. None of the patients had to see a doctor to sign up. Academic researchers doing similar trials might need several years to enrol only a few hundred patients. Pharmaceutical companies need scores of research sites and hundreds of millions of dollars to find 20,000 patients for a major drug trial.
"This is a whole new way of going forward with medical research that makes it quick, scalable and efficient," says Eric Topol, director of the Scripps Translational Science Institute in La Jolla, California, who is familiar with the apps but is not involved with developing them. The apps were all developed by researchers at academic medical institutions leading the studies.
Apps for more diseases are planned. The scientists are not testing new drugs, but rather hoping to learn more about the long-term effects of chronic disease on participants, including whether the use of a smartphone might help individual patients deal more effectively with their symptoms.
"The phone can be a powerful way to engage participants and make participating in a clinical study more of a two-way information exchange," says Stanley Shaw, co-director of the Centre for Assessment Technology and Continuous Health at Massachusetts General Hospital, Boston, where the diabetes app was developed.
For now, the apps work only on the iPhone 5, 5s, 6 and 6 Plus. Although tens of millions of Americans own an iPhone, the cost puts them out of reach of many lower-income earners. That raises questions about how relevant data from iPhone-based studies would be for the broader population. Apple plans to make the ResearchKit available soon on an open-source basis. That would enable development of apps for Android-based phones, which are often cheaper than iPhones, and potentially extend use of the apps to a broader population.
Apple says it does not collect or see any of the patient information researchers gather. Study participants have full control over when and whether their data, after it is uncoupled from their identity, can be shared with other researchers. Still, some worry a privacy risk remains. A significant privacy breach from app-based studies would be a "serious hit" to their use in clinical research, says Dr Topol, of the Scripps institute.
Researchers are intrigued by the transformative potential of smartphone apps. Kathryn Schmitz, an epidemiologist at University of Pennsylvania and an investigator on the Share the Journey study, says it recently took her team three years, including the sending of 60,000 notices, to recruit just 351 patients for a separate conventional study about the effect of exercise on breast-cancer survivors.
In the first month of recruiting for Share the Journey — which she says has less stringent enrolment criteria — nearly 2,000 patients have signed up. The apps also enable easy enrolment of patients no matter where they live in the US (Apple plans international study launches.)
With Parkinson’s disease patients, mobility is a big concern. For patients who live, say, in New Jersey or on Long Island, "the idea of getting into the city to an academic centre is way too overwhelming", says Todd Sherer, head of the Michael J Fox Foundation for Parkinson’s Research in New York, which is involved with several online research initiatives.
"But if you can bring the technology to their house, they are very excited to participate."
Smartphones also offer the capability to track people’s symptoms and activities continuously in their daily lives. In many conventional studies, patients might have just a few clinic visits a year for tests and symptom updates, and those snapshots may not provide a detailed picture.
"Patients say symptoms fluctuate over the course of a day, but we’ve never had a way of measuring that," says Ray Dorsey, a University of Rochester researcher who heads the Parkinson’s app study.
With a smartphone, patients and researchers can observe symptoms that may change hourly and see how the changes correlate with factors such as exercise, meal times and medication dose. The phone also objectively records measurements of activities — minutes of exercise, steps walked, hours of sleep — which in conventional studies are typically obtained from less-reliable patient recall.
Mr DeMello, who lives in Oakland, California, says he has 20-minute visits with his neurologist about once a quarter.
Yet, he lives with the disease 365 days a year. Each day, he uses his iPhone to take a finger-tapping test to determine his speed of movement, a walking test to check his gait and balance, a voice test and a memory test. Results measure the effect of his disease. So far, he says, he has learnt his symptoms do not move in lock step, contrary to what he used to think.
"I have weeks when balance is an issue and weeks when it’s not," he says. "Then I have weeks when I’m slower cognitively than others."
The app, he says, "is a huge step in giving patients a chance to contribute data that are otherwise completely lost."
Now, he says, "what I mostly want to do is learn how things come together in my body and what do I have to do to make them better".
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Picture: THINKSTOCK
STEVEN DeMello, like many people, uses a smartphone to keep a calendar, take notes, create artful photographs and listen to music. Recently, he began using it for a new purpose: to participate in a clinical trial.
Three times a day, the retired healthcare executive, who is 60 years old and has Parkinson’s disease, performs four tests using an app on his iPhone that records his results and provides feedback to researchers — and to him — on how his Parkinson’s symptoms affect his daily life.
"If I know more about my condition, the better and smarter I will be in managing my own care," he says. The app, called mPower, is one of five disease-related apps for clinical trials released in March in connection with Apple’s introduction of ResearchKit, a platform where users can track personal health data and participate in health studies. Other apps include My Heart Counts for cardiovascular disease, Asthma Health, GlucoSuccess for diabetes, and Share the Journey for a study of the aftereffects of treatment for breast cancer.
Together the apps — and patients like Mr DeMello — offer a glimpse of how the ubiquitous smartphone has the potential to transform medical research. Taking advantage of smartphone features such as accelerometers, gyroscopes and GPS locators, the apps track real-time daily activity and supplement other information on a patient’s condition.
Since the apps were launched on March 9, about 60,000 patients have enrolled in five studies just by downloading the apps from the app store, answering a few questions about the disease and clicking through a consent form. None of the patients had to see a doctor to sign up. Academic researchers doing similar trials might need several years to enrol only a few hundred patients. Pharmaceutical companies need scores of research sites and hundreds of millions of dollars to find 20,000 patients for a major drug trial.
"This is a whole new way of going forward with medical research that makes it quick, scalable and efficient," says Eric Topol, director of the Scripps Translational Science Institute in La Jolla, California, who is familiar with the apps but is not involved with developing them. The apps were all developed by researchers at academic medical institutions leading the studies.
Apps for more diseases are planned. The scientists are not testing new drugs, but rather hoping to learn more about the long-term effects of chronic disease on participants, including whether the use of a smartphone might help individual patients deal more effectively with their symptoms.
"The phone can be a powerful way to engage participants and make participating in a clinical study more of a two-way information exchange," says Stanley Shaw, co-director of the Centre for Assessment Technology and Continuous Health at Massachusetts General Hospital, Boston, where the diabetes app was developed.
For now, the apps work only on the iPhone 5, 5s, 6 and 6 Plus. Although tens of millions of Americans own an iPhone, the cost puts them out of reach of many lower-income earners. That raises questions about how relevant data from iPhone-based studies would be for the broader population. Apple plans to make the ResearchKit available soon on an open-source basis. That would enable development of apps for Android-based phones, which are often cheaper than iPhones, and potentially extend use of the apps to a broader population.
Apple says it does not collect or see any of the patient information researchers gather. Study participants have full control over when and whether their data, after it is uncoupled from their identity, can be shared with other researchers. Still, some worry a privacy risk remains. A significant privacy breach from app-based studies would be a "serious hit" to their use in clinical research, says Dr Topol, of the Scripps institute.
Researchers are intrigued by the transformative potential of smartphone apps. Kathryn Schmitz, an epidemiologist at University of Pennsylvania and an investigator on the Share the Journey study, says it recently took her team three years, including the sending of 60,000 notices, to recruit just 351 patients for a separate conventional study about the effect of exercise on breast-cancer survivors.
In the first month of recruiting for Share the Journey — which she says has less stringent enrolment criteria — nearly 2,000 patients have signed up. The apps also enable easy enrolment of patients no matter where they live in the US (Apple plans international study launches.)
With Parkinson’s disease patients, mobility is a big concern. For patients who live, say, in New Jersey or on Long Island, "the idea of getting into the city to an academic centre is way too overwhelming", says Todd Sherer, head of the Michael J Fox Foundation for Parkinson’s Research in New York, which is involved with several online research initiatives.
"But if you can bring the technology to their house, they are very excited to participate."
Smartphones also offer the capability to track people’s symptoms and activities continuously in their daily lives. In many conventional studies, patients might have just a few clinic visits a year for tests and symptom updates, and those snapshots may not provide a detailed picture.
"Patients say symptoms fluctuate over the course of a day, but we’ve never had a way of measuring that," says Ray Dorsey, a University of Rochester researcher who heads the Parkinson’s app study.
With a smartphone, patients and researchers can observe symptoms that may change hourly and see how the changes correlate with factors such as exercise, meal times and medication dose. The phone also objectively records measurements of activities — minutes of exercise, steps walked, hours of sleep — which in conventional studies are typically obtained from less-reliable patient recall.
Mr DeMello, who lives in Oakland, California, says he has 20-minute visits with his neurologist about once a quarter.
Yet, he lives with the disease 365 days a year. Each day, he uses his iPhone to take a finger-tapping test to determine his speed of movement, a walking test to check his gait and balance, a voice test and a memory test. Results measure the effect of his disease. So far, he says, he has learnt his symptoms do not move in lock step, contrary to what he used to think.
"I have weeks when balance is an issue and weeks when it’s not," he says. "Then I have weeks when I’m slower cognitively than others."
The app, he says, "is a huge step in giving patients a chance to contribute data that are otherwise completely lost."
Now, he says, "what I mostly want to do is learn how things come together in my body and what do I have to do to make them better".
More Africa news from The Wall Street Journal
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