By Ed Miseta, Chief Editor, Clinical Leader
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“The solutions are out there, but getting sponsors to use them has been like pulling teeth.” That comment, made to me by a technology solutions provider at this year’s Mobile in Clinical Trials conference held by the Conference Forum, seems to sum up the frustration of many mobile and wearable device manufacturers. Patient recruitment and retention remains a challenge for most pharma companies. New mobile tools bring the promise of a better patient experience, which would serve to alleviate both problems. And yet the conservative nature of pharma, coupled with regulatory concerns, seem to be keeping these solutions from gaining widespread adoption in trials. It’s no surprise that some technology companies are attempting to prove the effectiveness of these mobile tools themselves.
In 2015 Medidata Solutions sought to do just that, with a trial that incorporated mobile health tools (a Fitbit, mobile app, and text messaging) to measure activity levels and quality of life for 20 patients with mild to moderate Type 2 diabetes. All subjects recruited for the trial were using a Fitbit for the very first time.
“This was a mobile health trial in patients with Type 2 diabetes,” said Kara Dennis, Managing Director of mHealth for Medidata Solutions. “We worked with a clinician who believes that two very effective strategies for the management of Type 2 diabetes are increased activity and a healthier diet, which can help to better manage levels of glucose in the bloodstream. We wanted to evaluate whether mobile tools could improve adherence to a prescribed regimen of diet and exercise, and we measured this by looking at endpoints of blood glucose, weight, and activity.”
Beyond this clinical evaluation, Dennis also noted that Medidata was focused on understanding the potential for instrumenting subjects with sensors and mobile tools in a rigorously structured, regulatory-compliant setting. Medidata’s mobile team wanted to understand implementation challenges and solutions for addressing them. For example, training subjects to download and use an app. As a part of this study, Medidata developed and evolved a regulatory compliant technology platform and developed Good Clinical Practice (GCP) approaches for everything from mobile health trial design to IRB submission.
Prove To Me That It Works
All 20 subjects recruited for the study were able to use their own mobile phones, which required a downloaded Fitbit app. Each subject was also given a Fitbit to use, and was thoroughly trained in the proper use of it. Subjects were asked to increase their physical activity, which was then tracked via the number of steps taken and active minutes. Sleep quality and duration were also tracked. Each subject was also given specified milestones that they were asked to target. Finally, they were instructed to use a mobile app on their phone to fill out questionnaires about their quality of life, all of which was tracked over time.
“We wanted to look at the relationship between what they recorded about their quality of life and what we saw in terms of their activity and their sleep,” says Dennis. “The subjects also received text message notifications to remind them of the therapy guidance (better nutrition and exercise) from their physician.”
Medidata and other technology providers have been advocating for the use of mobile and wearable technologies in trials, but many sponsors seem to want to see proven results before jumping into a new technology. Dennis believes this Medidata-sponsored demonstration in a clinical trial setting will generate enthusiasm over future uses.
“When we started the trial the industry still seemed to be in the early phases of exploration,” she states. “We felt that by taking this on we might be able to accelerate the progress of adoption by demonstrating the effectiveness of this type of trial. We were able to show that it is possible to work through any operational challenges that might arise.”
Plan For Every Contingency
Medidata supplied the Fitbits to the site, made sure the subjects had phones, and ensured they knew how to use the technologies. Backup devices were also available in the event a phone or Fitbit was damaged or lost. Training was also provided to site coordinators to ensure they were prepared to answer any questions that might arise. Finally, a regulatory compliance technology infrastructure was purpose built for this trial. It was the first time Medidata built that infrastructure, which is now available for use in other trials.
Dennis notes the trial went smoothly and there were very few issues that arose. A few participants seemed concerned about whether the app would give Medidata access to personal information and photos stored on their phones. By and large, subjects were unconcerned about sharing their personal data on the questionnaires. A few were unclear about how to download an app to their phone. Overall, most of the feedback received was positive. Participants noted they especially enjoyed being able to track their sleep as well as their daily steps.
“Our goal all along was to demonstrate the feasibility of this,” adds Dennis. “We took all of the concerns we heard from companies about using mobile technology in trials and worked to address those objections -- we now have a playbook on how to do this that we can take back to our biopharma and CRO customers. On top of that, we fully expect mobile technologies to continue to improve. For example, when we started the study, the Fitbits available to consumers did not measure heart rate, but now we would have numerous options for activity trackers with heart rate. Almost month by month, we are seeing progress with these devices, which will bode well for future trials.”