Bracket launched its next generation clinical outcomes platform, Bracket eCOA 6.0, at the 52nd Annual DIA Meeting this week, June 26 to 30, 2016 in Philadelphia, Pennsylvania.
The platform integrates with Samsung Galaxy smartphones and Microsoft's Surface Pro Windows tablets to support ePro, eClinRO and eObsRO, and features integrated clinician and patient-facing tools.
It also enables the “Bring Your Own Device” (BYOD) approach, which allows patients to use their own smartphones to complete field-based PRO assessments.
This approach has been gaining significant traction, as an alternative to traditional models where phones are purchased for patients – which can come at a significant cost depending on the number of patients enrolled.
“15 years ago you would buy 300 palm pilots and build custom software on them and send them out [to patients],” Adam Butler, Bracket’s Sr. Vice President, Strategic Development told Outsourcing-Pharma.com.
Thus, Butler explained that BYOD becomes really appealing to someone that has to support a clinical trial. “ePro has become pretty big field in clinical research,” he added. “The adoption has really skyrocketed because it makes so much sense to do it.”
Specifically, when ePro is used in a clinical trial, compliance increases and data is more reliable, as a common concern about paper diaries is knowing at what point the patient is filling it out.
“What we’re seeing is this shift to exploring the use of BYOD,” said Butler. “This is relatively recent in past couple years that people have been trying to do this.”
BYOD in practice
Bracket recently evaluated the use of a BYOD mobile app to collect information in a Ph II clinical trial. The trial, Mobile Parkinson’s Disease Study (mPower), examined how Parkinson’s patients could better manage their symptoms via an application that included a mix of surveys and tasks that activated phone sensors to collect and track a patient’s progression.
According to Butler, there was a preconceived notion that patients wouldn’t want to use their own phone. However, he said that over the course of the study the researchers saw adoption of the mPower app “go up and up.” In fact, at the end of the study 80% of the study’s data was being submitted though the app.
“People took to it [the app] and wanted to use it,” he added, “and when they did compliance was really good,” Butler said, explaining that improved compliance was one of the key takeaways of the study.
Reaching a tipping point
Butler expects that the industry will see a “tipping point of very heavy adoption” of BYOD in clinical trials – and he expects this to happen in the next three to five years.
Additionally, “I think we will rapidly start to see expansion of ePro in general,” he said, “and as ePRO becomes more prevalent BYOD won’t be that far behind.”
However, he said that ePRo, in general, doesn’t have the adoption rate that many would like to see, but that the concerns surrounding it aren’t well founded.
“There’s been some really good research, specifically with elderly people using these devices … and it always comes out really good,” he explained.
Ultimately, the trade-off from the unreliability of paper diaries and the difficulty of managing paper is outweighed by the challenges of ePRO.
“The FDA also recommends that if you can do things electronically that would be their preference,” added Butler, who also works with the ePRO Consortium, part of the Critical Path Institute, to help advance the technologies.
“In the end it’s going to be a lot better for patents if it’s easier for them to participate in clinical trials … and this is a no brainer way to make it easier,” added Butler, “and if we make it work for them, it will work for us.”