title: Capturing Patient-Reported Outcome (PRO) Data Electronically: The Past, Present, and Promise of ePRO Measurement in Clinical Trials.
abstract: Patient-reported outcomes (PROs) are an important means of evaluating the treatment benefit of new medical products. It is recognized that PRO measures should be used when assessing concepts best known by the patient or best measured from the patient's perspective. As a result, there is growing emphasis on well defined and reliable PRO measures. In addition, advances in technology have significantly increased electronic PRO (ePRO) data collection capabilities and options in clinical trials. The movement from paper-based to ePRO data capture has enhanced the integrity and accuracy of clinical trial data and is encouraged by regulators. A primary distinction in the types of ePRO platforms is between telephone-based interactive voice response systems and screen-based systems. Handheld touchscreen-based devices have become the mainstay for remote (i.e., off-site, unsupervised) PRO data collection in clinical trials. The conventional approach is to provide study subjects with a handheld device with a device-based proprietary software program. However, an emerging alternative for clinical trials is called bring your own device (BYOD). Leveraging study subjects' own Internet-enabled mobile devices for remote PRO data collection (via a downloadable app or a Web-based data collection portal) has become possible due to the widespread use of personal smartphones and tablets. However, there are a number of scientific and operational issues that must be addressed before BYOD can be routinely considered as a practical alternative to conventional ePRO data collection methods. Nevertheless, the future for ePRO data collection is bright and the promise of BYOD opens a new chapter in its evolution.
authors.affiliation: Critical Path Institute, Tucson, AZ, USA, sjcoons@c-path.org.
authors.forename: Stephen Joel
authors.initials: SJ
authors.lastname: Coons
authors.forename: Sonya
authors.initials: S
authors.lastname: Eremenco
authors.forename: J Jason
authors.initials: JJ
authors.lastname: Lundy
authors.forename: Paul
authors.initials: P
authors.lastname: O'Donohoe
authors.forename: Hannah
authors.initials: H
authors.lastname: O'Gorman
authors.forename: William
authors.initials: W
authors.lastname: Malizia
mesh_terms: D016494:Computer Security; D003199:Computer Systems; D034201:Computers, Handheld; D003625:Data Collection / Q000379:methods* / Q000592:standards; D006801:Humans; D063868:Patient Outcome Assessment; D000068997:Smartphone; D013689:Telephone