Documenting the rationale and psychometric characteristics of patient reported outcomes for labeling and promotional claims: the PRO Evidence Dossier.

Full Abstract

The Food and Drug Administration (FDA) and European Medicines Agency (EMEA) are willing to consider including information on patient reported outcomes (PROs) in product labeling and advertising. Pharmaceutical industry researchers must provide sufficient evidence supporting PRO benefit before an approval may be granted. This report describes the purpose and content of a PRO Evidence Dossier, which consists of important information supporting PRO claims. The dossier should be completed by pharmaceutical industry or other researchers to document the planning of the PRO assessment strategy, psychometric evidence, desired target labeling statements, and the clinical trial evidence of PRO benefits. The systematic reporting and documentation of information on the rationale for including PROs, rationale for the selection of specific PRO instruments, evidence on the psychometric qualities of the PRO measures, and guidelines for interpreting PRO findings will facilitate achieving a PRO labeling or promotional claim. Combining all the relevant information into a single document will facilitate the review and evaluation process for clinical and regulatory reviewers. The PRO Evidence Dossier may also be helpful to industry and academic researchers in identifying further information that will need to be developed to support the clinical development program and the PRO endpoints.

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Author information

Author/s: Revicki, Dennis A (DA); Gnanasakthy, Ari (A); Weinfurt, Kevin (K);

Affiliation: Center for Health Outcomes Research, United Biosource Corporation, 7101 Wisconsin Ave., Suite 600, Bethesda, MD 20814, USA. dennis.revicki(-atsign-)unitedbiosource.com

Journal and publication information

Publication Type: Journal Article; Validation Studies

Journal: Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation (Qual Life Res), published in Netherlands. (Language: eng)

Reference: 2007-May; vol 16 (issue 4) : pp 717-23

Dates: Created 2007/03/26; Completed 2007/06/06; Revised 2007/11/15;

PMID: 17268927, status: MEDLINE (last retrieval date: 12/26/2008)

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

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MeSH headings (categories)

This article was linked to the MESH Headings shown below.

Advertising as Topic
Clinical Trials as Topic - methods; standards
Decision Making
Documentation
Drug Approval - methods
Drug Industry
Drug Labeling - standards

Drug Labeling - standards
Humans
Outcome Assessment (Health Care) - methods
Psychometrics - methods; standards
Quality of Life
United States
United States Food and Drug Administration

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