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[IRB]-Ensuring trial compliance? There's an app for that
[November 28, 2012]

[IRB]-Ensuring trial compliance? There's an app for that

(AHC Newsletters Via Acquire Media NewsEdge) Ensuring trial compliance There's an app for that Apps provide real-time protocol compliance data With the smartphone application market seemingly exploding with apps for just about anything, it's no surprise that clinical research is starting to get in on the action. Technology companies and academic institutions are working on research apps and other programs to assist with clinical trial data reporting.

"The Pew Research Center recently reported that 46% of Americans have a smartphone," says Joel Hughes, PhD, director of the Applied Psychology Center at Kent State University in Kent, OH. "It's very ubiquitous now, and will get greater and greater adoption. I see this as being a broadly applicable way to ensure adherence to protocol." With millions of people relying on their smartphones for everything from email to checking the weather and even monitoring their home security systems, clinical researchers are seeing the benefit of using the devices to monitor research subjects and even determine the effectiveness of healthcare apps. Pew Research Center reports that 52% of smartphone owners have sought health information on their phones.1 A quick check of ClinicalTrials.gov shows 45 registered trials that involve smartphones in some way, ranging from depression treatment to fitness, pain management, and medication compliance.

Hughes is currently using an iPhone app in a study to improve medication compliance in heart failure patients. The app gives Hughes and other researchers real-time data on patients' compliance rate. "When using an app, you know immediately what they're doing." Hughes says. "We know right away if they've dropped off the protocol." Patients using the app can set up a customizable medication schedule that will remind them to take their prescriptions at the appropriate times. The program can give patients further instructions for their medical conditions, and can report the results to researchers in real time.


"You know right away what the patients are doing you don't have to wait for them to come into the office," Hughes says.

Protecting privacy Since many of the study patients do not have smartphones, the researchers provide the phones as an incentive for participation. Hughes said that while the IRB had initial concerns about providing smartphones, they have become more open to the idea. "We've made nine IRB applications [for providing phones], and they've always gone through," he says.

"I think the IRB is wary of anything they haven't seen before," he says. "Their job is to protect human subjects. With apps, there's more accuracy, a lower dropout rate, and immediate reporting of adverse events. We don't have to wait to hear from patients they can tell us right now. Over time, the IRB became very receptive." The biggest concern has been privacy, but Hughes and his team have found ways to make the devices more secure. "With any patient device, you want to make sure it's secure and HIPAA-compliant," he says. When patients enter their data in the phone apps, it's transmitted to the study server, de-indentified, and encrypted. "No one knows the patient's name or the medications taken, even if the information is de-encrypted," Hughes says. "You only know what button was pushed. It helps tremendously with security." And if a phone is lost, data can be erased remotely.

"Smartphones don't discriminate with access to care nearly 50% of people in this country have smartphones," he says. "Age can be an issue while usage isn't as widespread for the elderly, we do provide for them. As the cohort ages, access to smartphones will be surprising." Hughes also sees clinical trials apps and software expanding to include even more data. "I think they will include a more graphical interface to report back to the clinician," he says. "For example, if the user is taking their blood pressure, the numbers can immediately come back to the provider and the researcher. We can also push education to patients, including podcasts that will show them exactly what they need to do." But while Hughes sees big possibilities, it's still all a matter of getting there. "There are many exciting possibilities, but it's technologically challenging and expensive," he says.

Reach a large audience by texting Smartphone apps aren't having all the fun in clinical research text messaging is also being investigated in research as a way of effectively reaching a large population. Brian Mustanski, MD, associate professor and director of the IMPACT LGBT Health and Development Program of Northwestern University in Chicago, is leading a trial to investigate the effectiveness of using text messages to educate adolescent bisexual and gay men on HIV prevention. "It's a very interactive, intense dosing of education," Mustanski says. "We can really get away with sending them a good number of texts." The texting program will send participants information on safe sexual practices and HIV prevention. The researchers will review the participants' sexual history after three months to measure the effectiveness of the messages.

Mustanski's team educated participants on possible privacy issues, and received IRB approval with "no major snags." "Using this technology raises typical concerns about privacy and consent," he says. "We work with young people so that they understand the privacy of their phones, that they're the only ones who can see the messages, and what happens if other people see them. We've done formative work and focus groups this year, and we know they are the best ones at using their phones and knowing what's private and not private. The last thing we would want is for the parents of someone who is not out to see the messages and have a conflict.

"We deal with this every day as far as privacy with their sexual orientation," Mustanski says. "We have a waiver of parental consent because it might not be safe for the subjects to come out to their parents. We interview with the young person over the phone so they know the risks and benefits of the study. Similar studies haven't had problems with young people being hesitant." Mustanski's studies have not yet expanded into smartphone apps. "Texting is still so ubiquitous," he says. "Apps are more limited to people who have smartphones. Though [smartphone] ownership is expanding very, very quickly, it doesn't yet meet the highest-need young people. If we're very successful with the text messages, then it could be used for smartphones." Reference    • Pew Research Center. Mobile Heath Finds its Market in Smartphone Owners. http://pewresearch.org/pubs/2421/mobile-health-information-smartphone-cell-phone-apps-softwareSOURCE-IRB Advisor (c) 2012 AHC Media LLC. All Rights Reserved.

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