09 Aug What are Wearable Reported Outcomes (WRO)?
WRO enable fundamentally a new class of clinical studies where the data from participants is collected in an unobtrusive manner at significantly large scale in terms of volume of data generated from the wearable devices. The amount and quality of data collected via ePRO methods is usually small and has significant drop-off of patients at various steps during the clinical study process.
Why a new acronym?
There exists a big set of alphabet soup already (eCOA, CRF, ePRO…) in the space, and why are we introducing yet another acronym to make the soup frothier? The answer is we think there is a fundamental shift with digital health where consumers empowered medical grade devices on their wrists are able to monitor their own health. Using this data in clinical research changes how studies are designed and outcomes are analyzed. In some sense, this is arrival of BIG data into clinical research. So a WRO study warrants new approaches to the following
- Clinical Trial Design
- Participant Recruitment
- Wearable Data Collection Methods
- Clinical Validation of Data
- Multi-Device Data Correlation
- Streaming Data Storage Tools
- Big Data Analytics
For each of these steps there needs to be a re-thinking of best practices, tools and methods. Hence the need for a new term to collect ideas and thoughts around this.
GetWRO – Launch your WRO Study Today
In June at the DIA 2016 conference, we launched a solution for researchers to conduct clinical studies using data from wearables devices and then also push the data to their existing EDC/CTMS systems. Read more about GetWRO in our press release :