In November 1997, the Mapi Research Institute organized an exploratory meeting, which brought together health-related quality of life (HRQL) researchers and representatives from European regulatory agencies and the FDA.
The main objective of this meeting was to highlight the regulatory authorities' concerns about HRQL evaluation in clinical trials.

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Welcome to the new website version of the ERIQA Group!

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An Educational Program on Health Related Quality of Life (HRQL) and Patient-Reported Outcomes in Clinical Trials and Observational Studies was held at the...

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Two main conclusions were made:

There is a need to rationalize the field of HRQL research and to make HRQL a credible criterion for the evaluation of new therapies by health authorities.

This issue can only be resolved through a better collaborative effort between key players: mainly health authorities, HRQL researchers and pharmaceutical companies.

Following these conclusions, the European Regulatory Issues on QoL Assessment (ERIQA) Group was created, with the following mission statement:

" Establishing principles and practices for the integration of Health-related Quality of Life outcomes in the drug regulatory process "

The objectives of the ERIQA Group are:

To provide European regulatory authorities with guidance on how to assess the quality of HRQL studies in clinical trials, and on how to evaluate the validity of HRQL claims, for appropriate decision-making.

To convince European regulators that HRQL is a relevant key outcome, i.e. a credible criterion in the evaluation of medicines.