Article | April 3, 2012

Collecting PROs Via The Web: Are Data Suitable For Regulatory Submissions?

Source: PHT Corporation

By Chris Hall

The proliferation and global adoption of the web is prompting biopharmaceutical decision makers to ask how the Internet can be leveraged to expedite clinical trials. It is reasonable to presume that large populations of patients are web-savvy and that they have Internet access. As such, it is possible to leverage the web as a mode of administration for clinical research. A key question many sponsors are asking is can the web be used to collect patient reported outcomes that support label claims?

This article will describe the web-based mode of administration for electronic patient reported outcome (ePRO). It will explain which types of trials are best suited for this mode of administration, discuss psychometric validations required, and explain how and when ePRO data collected via the web can support a claim.