Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims:
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Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research*1, U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research*2 and U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health*3 Address: 1U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 2085, USA, 2U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, USA and 3U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Drive, Rockville, MD 20850-430, USA Email: U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research* - [email protected]; U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research* - [email protected] ; U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health* - [email protected] * Corresponding authors
Published: 11 October 2006 Health and Quality of Life Outcomes 2006, 4:79
doi:10.1186/1477-7525-4-79
Received: 21 April 2006 Accepted: 11 October 2006
This article is available from: http://www.hqlo.com/content/4/1/79 © 2006 Burke et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract This guidance describes how the FDA evaluates patient-reported outcome (PRO) instruments used as effectiveness endpoints in clinical trials. It also describes our current thinking on how sponsors can develop and use study results measured by PRO instruments to support claims in approved product labeling (see appendix point 1). It does not address the use of PRO instruments for purposes beyond evaluation of claims made about a drug or medical product in its labeling. By explicitly addressing the review issues identified in this guidance, sponsors can increase the efficiency of their endpoint discussions with the FDA during the product development process, streamline the FDA's review of PRO endpoint adequacy, and provide optimal information about the patient's perspective of treatment benefit at the time of product approval. A PRO is a measurement of any aspect of a patient's health status that comes directly from the patient (i.e., without the interpretation of the patient's responses by a physician or anyone else). In clinical trials, a PRO instrument can be
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