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Health-Related Quality of Life and Other Patient-Reported Outcomes in the European Centralized Drug Regulatory Process: A Review of Guidance Documents and Performed Authorizations of Medicinal Products 1995 to 2003

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References

2000Recommendations on health-related quality of life research to support labeling and promotional claims in the United States577 cited
2003Incorporating 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, 2001515 cited
1999Recommendations for Evaluating the Validity of Quality of Life Claims for Labeling and Promotion387 cited
2002Patient-Reported Outcomes: The Example of Health-Related Quality of Life—a European Guidance Document for the Improved Integration of Health-Related Quality of Life Assessment in the Drug Regulatory Process365 cited
2004Measuring treatment impact: a review of patient-reported outcomes and other efficacy endpoints in approved product labels304 cited
2003The significance of quality of life in health care140 cited
2001Health-Related Quality of Life (HR-QOL) and Regulatory Issues87 cited

Cited by

2020How to Include Patient-Reported Outcome Measures in Clinical Trials49 cited

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