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    Marquis, Patrick Caron, Martine Emery, Marie-Pierre Scott, Jane A. Arnould, Benoit and Acquadro, Catherine 2011. The Role of Health-Related Quality of Life Data in the Drug Approval Processes in the US and Europe. Pharmaceutical Medicine, Vol. 25, Issue. 3, p. 147.

    Hao, Yanni 2010. Patient-reported outcomes in support of oncology product labeling claims: regulatory context and challenges. Expert Review of Pharmacoeconomics & Outcomes Research, Vol. 10, Issue. 4, p. 407.

    Koninckx, Philippe R. 2008. Videoregistration of Surgery Should be Used as a Quality Control. Journal of Minimally Invasive Gynecology, Vol. 15, Issue. 2, p. 248.

    Rogowski, Wolf H Hartz, Susanne C and John, Jürgen H 2008. Clearing up the hazy road from bench to bedside: A framework for integrating the fourth hurdle into translational medicine. BMC Health Services Research, Vol. 8, Issue. 1,

  • International Journal of Technology Assessment in Health Care, Volume 20, Issue 3
  • August 2004, pp. 311-324

EMEA and the evaluation of health-related quality of life data in the drug regulatory process

  • Sotiria Papanicolaou (a1), David Sykes (a1) and Elias Mossialos (a2)
  • DOI:
  • Published online: 01 August 2004

Objectives: This study reviewed the European guidelines of the Committee for Proprietary Medicinal Products (CPMP) on how health-related quality of life (HRQOL) research should be conducted in clinical trials. Published product-level information was also reviewed to investigate the actual role of HRQOL data in the European regulatory process.

Methods: All disease-specific notes for guidance and concept papers on clinical investigations, development and evaluation of human medicinal products, as well as the European Public Assessment Reports (EPAR) of all approved drugs published on the European Agency for the Evaluation of Medicinal Products (EMEA) Web site were evaluated for their HRQOL recommendations.

Results: Only twenty of the fifty CPMP guidance notes for clinical investigation of pharmaceutical products in specific disease areas included a reference to HRQOL. Most of the recommendations were generic and vague, and the terminology used was inconsistent across documents. The EPAR provided nonspecific information about HRQOL and contradictory conclusions on the effect of a drug on HRQOL sometimes occurred in different documents. The criteria used by the CPMP to assess the HRQOL data could not be identified due to an ad hoc approach to the inclusion of data in the EPAR.

Conclusions: A more systematic approach is needed on the way health outcomes data are considered, reviewed, and interpreted by the regulatory authorities. For this to be achieved, CPMP should develop general guidelines on the importance of HRQOL and how research should be conducted if data are to be included in the registration process.

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International Journal of Technology Assessment in Health Care
  • ISSN: 0266-4623
  • EISSN: 1471-6348
  • URL: /core/journals/international-journal-of-technology-assessment-in-health-care
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