At the mHealth Summit outside of Washington, D.C. last week, Mike Shilling, director of business development at Exco InTouch, shared three examples of mobile-enabled clinical trials that recently finished up or are still underway. The trials each leveraged mobiles in different ways and helped highlight a few of the strategies for deploying them in support of a trial as well as the various benefits. Shilling highlighted three benefits enabled by mobile technology: Larger, more comprehensive trials; shorter, less expensive trials; and near real-time data analysis of patient reported outcomes.
The first trial Shilling described was a phase three clinical trial that spanned a number of countries and its aim was to demonstrate the efficacy of an influenza vaccine in a pediatrics population. Shilling said this trial used a bring your own device approach and that since it was tracking children, it involved their parents or carers, not the patients themselves as the engaged participant.
“The caregivers were involved in this even though my 20-month-old granddaughter can probably use the iPad as well as I can,” Shilling said. “The caregivers were very important in this study as they answered the questions about the flu. The idea was they needed to respond to questions about symptoms their children were showing that were signs of flu. There were a lot of subjects — 8,200 — and the answers to the questions formed a daily diary.”
The initial question about signs of the flu led to a number of others depending on responses. Initial questions were along the lines of: “Has your child’s health changed since yesterday?” If a caregiver said their child had a body temperature approaching a fever, then the questions would start asking about other symptoms and, when appropriate, alert a nurse from the site to follow-up.
Shilling said the study used SMS reminders to help caregivers remember to fill out the daily diary and since it was BYOD, the study participants used their mobile devices, PCs or laptops, or a device provisioned by the study coordinators if they didn’t want to use their own or didn’t have one to use. Shilling said about 68 percent opted to use their own mobile device, while 16 percent chose to use a PC or laptop in their home.
BYOD enabled a lot of subjects to participate in the study, Shilling said. Because so many of these caregivers had mobile devices, the site did not have to take on the task of calling each of them individually every single day. The system also alerted the site if a diary was late or incomplete each day — real-time monitoring that is nearly impossible with paper-based diaries.
Shilling also discussed a longterm study focused on heart patients who had already had one heart-related episode. This outcome event monitoring study has involved about 13,000 patients across 30 countries and has been running for six years and counting.
“The challenge here was it was a long duration with an unknown endpoint,” Shilling explained. “These patients had all already had a cardiovascular event and this study was looking for a second cardiovascular event. You didn’t know when an event was going to occur and because these patients didn’t know if they were ever going to have another even — and hopefully they never do have another event — but it was difficult to keep them engaged in the study.”
For this study, Exco InTouch employed a one-way SMS messaging service that aimed to keep the patients involved and engaged in the study. It told them how to prep for upcoming visits to the study site — “Fast for five days ahead of time”, for example. Shilling said that overall 44 percent of the patients opted into the reminder service. The study sponsor wanted it to be optional, and so far the study has shown that there is a five percent increase in the perfect visit window of compliance. There has also been a 1.5 percent reduction in patients who withdrew consent and a 4.5 percent reduction in patients who withdrew from the investigational product, Shilling said.
“We try to look at these studies with sponsors and try to see the return on investment,” he said. “With all studies you are looking for events and to get to an endpoint faster… If 1 in 9 experience an event across the entire study and all patients were actually using this, we calculated that there would probably be 87 additional events reported, which equated to about a four month earlier finish for the study. So, if a study was costing $3.5 million a month, then total return on investments was approximately $14 million for the length of the study.”
Since the mobile reminders increased compliance, the data was better and the study’s endpoints were likely to be met sooner. Quicker trials are less expensive trials.
The third and final example Shilling shared was about a study in Argentina. This post-marketing study to assess the medication adherence of patients with diabetes in an emerging market included provisioned smartphones, a connected medical device, and an app.
“The challenge here was this was being deployed to pharmacists,” Shilling said. “The pharmacists were collecting patient reported outcomes in busy pharmacies and they didn’t have a lot of data collection experience. They were getting verbal responses from the patients — so these were in essence like sight assessments — but they also received physiological readings from a blood analyzer as well, which was [transmitting data to] an app.”
Shilling said one smartphone was provisioned to each pharmacy and the patient reported outcome data and the data from the blood analyzer device was accessible in near real-time via a web-based portal so that the study sponsor or the site could review and analyze the data immediately after it was collected.
One of Shilling’s co-presenters was Pharmica Consulting’s Principal Matt Hendricks, who lauded pharmaceutical companies for exploring digital health technologies in their research studies, but called on the industry to do more — and soon.
“[Clinical trials] is the appropriate vector to begin to use some of these [digital health technologies], because they are already a well-funded, well-trodden way to test out new approaches in research,” Hendricks said. “We think there is something beyond that. We call on the industry to move more aggressively in exploring the use of these technologies for … better management of chronic disease.”