Task Force Report of the Patient-Reported Outcomes Harmonization Group- Too Much Harmony, Not Enough Melody?

Sep 1, 2003, 00:00
10.1046/j.1524-4733.2003.65002.x
https://www.valueinhealthjournal.com/article/S1098-3015(10)60163-5/fulltext
Title : Task Force Report of the Patient-Reported Outcomes Harmonization Group- Too Much Harmony, Not Enough Melody?
Citation : https://www.valueinhealthjournal.com/action/showCitFormats?pii=S1098-3015(10)60163-5&doi=10.1046/j.1524-4733.2003.65002.x
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Open access? : No
Section Order : 12
The Ad Hoc Task Force of the Patient Reported Outcomes Harmonization Group had an important opportunity to interact with the FDA and move toward consensus on unresolved issues within the field. The Task Force is to be commended for building bridges to the FDA and working for several years to increase the level of regulatory acceptance of outcomes research. No doubt these insights will be incorporated in the forthcoming FDA guidance on patient-reported outcomes. However, the initial report of the Task Force, published in this issue of Value in Health, has failed to communicate the value of these meetings. The report does not mention the areas of controversy and debate that led to the need for meeting with the FDA, and deliberately avoids providing prescriptions or recommendations, fearing they would inhibit the growth of the field.
Categories :
  • Best Research Practices
  • Organizational Practices
  • Patient-Centered Research
  • Patient-reported Outcomes & Quality of Life Outcomes
  • PRO & Related Methods
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Regions :
  • Global
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