Mapi Research Trust provides reliable, comprehensive and up-to-date information services to research scientists, pharmaceutical companies, and governmental health agencies involved in the field of Patient-Centered Outcomes worldwide.

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.

Since August 2001, the ERIQA Group (through Mapi Research Trust) has been recognized by the European Medicines Agency (EMA) as one of the interested parties and has been invited to comment on Efficacy Working Party (EWP) documents.

The ERIQA Group has 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:

carre6 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
carre6 Review of the draft EMA reflection paper on HRQL assessments (2006)
carre6 Review of the draft FDA guidance on PRO measures (2006)
carre6 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

carre6 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.
carre6 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:

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