Health-Related Quality of Life and Other Patient-Reported Outcomes in the European Centralized Drug Regulatory Process: A Review of Guidance Documents and Performed Authorizations of Medicinal Products 1995 to 2003

There is further scope for health outcomes researchers and regulatory decision-makers to contribute to the more efficient utilization of PROs and HRQL outcomes. Health researchers need to better justify the inclusion of these outcomes in clinical trials and highlight the added value of PRO data; while the regulators should develop harmonized procedures and capacities to adequately appraise the submitted information.