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

Published online by Cambridge University Press:  01 August 2004

Sotiria Papanicolaou ,
David Sykes  and
Elias Mossialos
Sotiria Papanicolaou
Affiliation:
Eli Lilly and Company Limited
David Sykes
Affiliation:
Eli Lilly and Company Limited
Elias Mossialos
Affiliation:
LSE Health and Social Care
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Abstract

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.

Keywords

Clinical trialsDrug regulationHealth statusHealth-related quality of life instrumentsQuality of life
Type
GENERAL ESSAYS
Information
International Journal of Technology Assessment in Health Care , Volume 20 , Issue 3 , August 2004 , pp. 311 - 324
Copyright
© 2004 Cambridge University Press

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