Collecting Electronic Patient-Reported Outcomes (ePROs):
Comparing the 5 Proven Ways to Acquire Attributed Patient-Reported Data
The Growing ePRO Industry
In 2010 it is estimated that 30% of new global trials will require subjective patient data, ie they will collect patient-reported outcomes as an endpoint. While paper diary collection is the default method for many latent-adopters of new technologies, electronic capture of patient-reported outcomes is growing steadily as sponsors realize the revenue advantages of more accurate, attributable patient-reported data.
PHT Corporation was one of the first organizations to specialize in collecting and reporting patient-reported outcomes electronically. Since 1994 the PHT ePRO System has become the market's ePRO system of choice, used in 400+ clinical trials. Unlike other ePRO providers, PHT is dedicated to ePRO as its core competency.
The Process of Collecting Electronic Patient-Reported Outcomes
Recommendations for collecting PRO measures have been set forth by the myriad guidelines and regulations, and include:
- Endpoint models clearly associated with the intended claims
- PRO measures that are valid, reliable and sensitive to change
- A well defined conceptual framework of the PRO instrument,
- Evidence that PRO data collection was completed at protocol-specified time
As a result of these guidances, the process of collecting electronic patient-reported outcomes requires much more than a collection device, database, and a diary or questionnaire! Since 1994, the PHT ePRO System has included these distinct yet interoperating functions based on ISO 9001: 2008 quality standards:
The Five Reliable Collection Methods and Devices Used to Collect ePRO
While the flurry of new patient-owned mobile devices may seem adaptive to ePRO collection and perhaps practical, using the patient's own technologies to capture ePRO can be risky for many reasons including
- Psychometric validity of multiple types of devices, and
- Data security and compliance with regulatory guidelines.
| ...using the patient's own technologies to capture ePRO can be risky for many reasons... |
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Each ePRO collection method and device must be thoroughly vetted in order to comply with various FDA, EMA and country regulations and requirements for clean, attributable data. As a result, there are currently five proven and tested ePRO technologies used by sponsors today (listed alphabetically):
- Hand Held Device: Electronic data capture on a mobile device with a central system that allows for web review;
- IVR (Interactive Voice Response): Keypad or voice data capture with a central system that allows for web review by site and sponsor;
- Internet Web data capture with a central system that allows for web review by site and sponsor;
- Pen: Digital pen that captures data and uploads to a central system that allows for web review; and
- Tablet: Electronic data capture on a tablet mobile device with a central system that allows for web review.
Download the review of each collection option here.
