Bracket initiates BYOD ePRO study in Japan

25-Apr-2017 - Last updated on 26-Apr-2017 at 15:13 GMT

Bracket eCOA integrates with devices to support ePRO, eClinRO and eObsRO use. (Image: iStock/Poike)

Bracket has launched a Bring Your Own Device (BYOD) electronic patient-reported outcome (ePRO) Ph III study in Japan.

The Phase III endocrinology trial is currently recruiting adolescents in Japan, Adam Butler, SVP strategic development at Bracket told Outsourcing-Pharma.com.

As part of the study, the clinical trial technology and services provider made smartphones available to patients who needed them – enabling them to complete questionnaires about their symptoms, medication use, and quality of life, via the company’s Patient Diary application.

“One really important challenge in any BYOD study is making sure patients without access to a smartphone, or who are hesitant to use their own smartphone, have a feasible alternative,” Butler explained.

“Right now, our focus is on making sure all the patients are completing their diaries and getting their data submitted. It’s early, but going well,” he added.

BYOD in Japan

According to the company, it is among the first to use BYOD in a randomized clinical trial in Japan – a country in which ePRO is already well accepted, Butler said.

“US sponsors have been hesitant about embracing BYOD outside North America. For studies where BYOD is feasible from a clinical perspective, we don’t think geography should be a barrier to adoption,” he added.