Linked Life Data

14627058

Source:http://linkedlifedata.com/resource/pubmed/id/14627058

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pubmed-article:14627058pubmed:abstractTextThe extent to which patient-based outcomes can be used to evaluate and communicate the effect of new drugs and devices is a subject of much debate. Criteria for evaluating the scientific quality of data to support health-related quality of life (HRQL) and other patient-based labeling and promotional claims in the United States and Europe have been proposed by various scientists and organizations. Since March 2000, a working group composed of members of the International Society for Quality of Life Research (ISOQOL), the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), the Pharmaceutical Manufacturer's Association Health Outcomes Committee (PhRMA-HOC), and the European Regulatory Issues on Quality of Life Assessment (ERIQA) met to discuss and coordinate the various recommendations by their respective groups and address the need to harmonize outcomes review criteria within and across United States and European regulatory agencies. Over time, the discussion expanded from HRQL outcomes to include any outcome based on data provided by the patient or patient proxy, that is, patient-reported outcomes (PROs). The working group therefore became known as the PRO Harmonization Group.lld:pubmed
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pubmed-article:14627058pubmed:articleTitleIncorporating the patient's perspective into drug development and communication: an ad hoc task force report of the Patient-Reported Outcomes (PRO) Harmonization Group meeting at the Food and Drug Administration, February 16, 2001.lld:pubmed
pubmed-article:14627058pubmed:affiliationMAPI Research Institute, Lyon, France. cacquadro@mapi.frlld:pubmed
pubmed-article:14627058pubmed:publicationTypeJournal Articlelld:pubmed
pubmed-article:14627058pubmed:publicationTypeResearch Support, Non-U.S. Gov'tlld:pubmed
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