PQP2: ROLE OF HEALTH RELATED QUALITY OF LIFE OUTCOMES IN THE EUROPEAN DRUG REGULATORY PROCESS: A REVIEW OF THE EMEA DOCUMENTS

Abstract

INTRODUCTION: The ERIQA Group aims to create guidance for European regulatory authorities on the assessment of the quality of HRQL studies in clinical trials and to evaluate the validity of HRQL claims. OBJECTIVES: To identify disease or drugs in which a formal HRQL assessment is recommended. To identify measures and methods recommended. To evaluate the reliability of recommendations across documents. METHODS: Informations were searched on the EMEA website (www. eudra.org/emea.html). A research was performed with the two key words: ?Quality of life? and ?QoL?. All the documents retrieved were reviewed. RESULTS: 133 documents were retrieved excluding duplicates (129: Quality of Life, 25: QoL). 19 documents derived from the Efficacy Working Parties (EWP) including nine notes for guidance (Weight Control, Cancer, Chronic Peripheral Arterial Occlusive Disease, Cardiac Failure, Stable Angina Pectoris, Antiarrythmics, Parkinson, Alzheimer, Multiple Sclerosis), concept paper (3), points to consider (5) and position statements (2). Only one document was a note for guidance for ICH. 104 European Public Assessment Report (EPAR) were retrieved, representing 26 products. Nine miscellaneous documents were found including minute reports, workshop, letters (5), assessment/opinion (2) from the CPMP and 2 documents were produced by the CVMP. CONCLUSIONS: The recommendations from the EMEA are vague in most cases, too generic, inconsistent between each other and reveal in some cases a lack of knowledge of the field. These recommendations are not up-dated and do not exist in relevant diseases (HIV/AIDS, HBP). Nevertheless, recommendations do exist showing a real interest in HRQL and recognition of HRQL as a valuable endpoint (mainly secondary).