Recent Trends in the Inclusion of Patient-Reported Outcome (PRO) data in Approved Drugs Labeling by the FDA and EMEA Martine Caron1 | Marie-Pierre Emery1 |  Patrick Marquis2 |  Elizabeth Piault2 | Jane Scott3	PDF File
1 MAPI Research Trust, Lyon, France  2 MAPI Values, Boston, USA  3 MAPI Values, UK

Abstract

The PROLabels database (http://www.mapi-prolabels.org/) was developed to provide easy access to the Patient-Reported Outcomes (PROs) included in approved labeling of products in Europe and the USA. When it was launched in 2006, the PROLabels database contained information from approved labeling of drugs approved by the EMEA since January 1995 and new molecular entities (NME) approved by the FDA since January 1998. Coverage of FDA labels has been expanded to give a more comprehensive image of the current use of PROs in clinical studies. The extension project added other chemical types approved by the FDA and consisted in the review of FDA labels for all new drug approvals and most of the revisions published on the FDA website since 1998.
The expanded PROLabels database allows us to observe the recent trends in PRO claims in Europe and in the USA. The most frequently measured type of PRO claim is Signs and Symptoms (the subject of 80% of PRO claims). This is followed by Health-Related Quality of Life (HRQL) which is measured in 16% of products approved with PRO claims. When European and American drug approvals are compared for the same product, a high degree of similarity is found.
This extension of the FDA coverage of the PROLabels database provides a clearer picture of the use of PROs to assess patients' treatment benefit. In addition, it facilitates the comparison between the US and European regulatory agencies.

Introduction

The PROLabels database (http://www.mapi-prolabels.org/) is a unique on-line tool which collects information on medical products for which the Food and Drug Administration (FDA) and/or the European Medicines Agency (EMEA) have granted a PRO labeling claim. It was co-developed by MAPI Research Trust and MAPI Values in 2006.