The European Regulatory Issues on Quality of Life Assessment (ERIQA) program

As a result of the development of hundreds of HRQoL instruments over
the last 20 years, the regulatory authorities expect assurance of the value and credibility of HRQoL evaluation in the clinical trials of new treatments.

Recognising this need, MAPI Research Trust established the European Regulatory Issues on Quality of Life Assessment (ERIQA) Group in 1998. The ERIQA Group brings together HRQoL researchers, representatives from pharmaceutical companies, and healthcare authorities with the objective of establishing HRQoL as a credible criterion for evaluation in clinical trials.

The ERIQA Group aims at establishing principles and practice guidelines for the integration of HRQoL outcomes in the regulatory process.

Since August 2001, the ERIQA Group (through MAPI Research Trust) has been recognized by the European Agency for the Evaluation of Medicinal Products (EMEA) as one of the interested parties and has been invited to comment on the Efficacy Working Party (EWP) documents.

The ERIQA Group collaborates with other similar initiatives to ensure maximum consistency between regulatory decisions in Europe and the USA (see PRO Harmonization Group), as well as establishing links with Russian, Japanese, and Chinese health authorities.



Program Outline

Phase 1:

A comprehensive review of existing guidelines for the implementation of HRQoL assessment in clinical trials, focusing on the documents produced by the EMEA;

 Development of a general guidance document to help regulatory authorities evaluate the quality of HRQoL assessment in randomized clinical trials and the validity of HRQoL claims;
 The formation of pilot working groups including a group on the added-value of HRQoL outcomes in clinical trials in general and in disease-specific groups;
 The organization of Harmonization Meetings, where regulators are invited as observers and where crucial issues of the HRQoL and PRO fields are discussed (see PRO Harmonization Group).

Phase 2:

This will involve consensus meetings on specific therapeutic areas with clinicians, the pharmaceutical industry and regulatory agencies in order to develop final consensus guidelines.

For more information about the ERIQA Programme:www.eriqa-project.com