Abstract of ISPOR document:
Patient-reported outcomes (PROs) are the consequences of disease and/or its treatment
as reported by the patient. The importance of PRO measures in clinical trials for new drugs, biologic
agents, and devices was underscored by the release of the US Food and Drug Administration’s draft
guidance for industry titled "Patient-Reported Outcome Measures: Use in Medical Product Development
to Support Labeling Claims."
The intent of the guidance was to describe how the FDA will evaluate the appropriateness and adequacy of PRO measures used as effectiveness endpoints in clinical trials. In
response to the expressed need of ISPOR members for further clarification of several aspects of the draft
guidance, ISPOR’s Health Science Policy Council created three task forces, one of which was charged
with addressing the implications of the draft guidance for the collection of PRO data using electronic data
capture modes of administration (ePRO).
The objective of this report is to present recommendations from
ISPOR’s ePRO Good Research Practices Task Force regarding the evidence necessary to support the
comparability, or measurement equivalence, of ePROs to the paper-based PRO measures from which
they were adapted.
Click this link to view the document: Recommendations on Evidence Needed to Support Measurement Equivalence between Electronic and
Paper-based Patient-Reported Outcome (PRO) Measures: ISPOR ePRO Good Research Practices Task
Force Report |
