Recommendations on Evidence to Support Equivalence between Electronic and Paper-based Patient-Reported Outcomes

September 3, 2015
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for new drugs, biologic agents, and devices was underscored by the release of the US Food and Drug Administration’s draft guidance for industry titled "Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims."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 In response to the expressed need of ISPOR members for further clarification of several aspects of the draft guidance, ISPOR’s Health Science Policy Council created three task forces, one of which was charged with addressing the implications of the draft guidance for the collection of PRO data using electronic data capture modes of administration (ePRO).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.
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Guidance for Industry Electronic Source Data in Clinical Investigations
Guidance for Industry Electronic Source Data in Clinical Investigations

This guidance provides recommendations to sponsors, Contract Research Organizations (CROs), clinical invest...