The European Regulatory Issues on Quality of Life Assessment (ERIQA) Project
As a result of the development of hundreds of HRQL instruments over the last 20 years, the regulatory authorities have expected assurance of the value and credibility of HRQL evaluation in the clinical trials of new treatments.
Recognizing this need, Mapi Research Trust established the European Regulatory Issues on Quality of Life Assessment (ERIQA) Group in 1997. The ERIQA Group brought together HRQL researchers, representatives from pharmaceutical companies, and healthcare authorities with the objective of establishing HRQL as a credible criterion for evaluation in clinical trials.
The ERIQA Group aimed at establishing principles and practice guidelines for the integration of HRQL outcomes in the regulatory process.
In August 2001, the ERIQA Group (through Mapi Research Trust) was recognized by the European Medicines Agency (EMA) as one of the interested parties and invited to comment on the Efficacy Working Party (EWP) documents.
The ERIQA Group collaborated with other similar initiatives to ensure maximum consistency between regulatory decisions in Europe and the USA (see PRO Harmonization Group).
In a period of 10 years (1997-2007), the ERIQA Group led several actions:
- Development of a general guidance document to help regulatory authorities evaluate the quality of HRQL assessment in randomized clinical trials and the validity of HRQL claims
- Review of the draft EMA reflection paper on HRQL assessments (2006)
- Review of the draft FDA guidance on PRO measures (2006)
- Formation of pilot working groups including a group on the added-value of HRQL outcomes in clinical trials in general and in disease-specific groups
- Organization of educational sessions on HRQL and PRO asessment in clinical trials using the PROmats for the benefits of regulators of the FDA, EMA, Afssaps, ANAES, INAMI, etc.
- Organization of Harmonization Meetings, where regulators were invited as observers and where crucial issues of the HRQL and PRO fields were discussed (see PRO Harmonization Group)
For more information about the ERIQA Group: www.eriqa-project.com