New developments in PROLabels, the online database of Patient-Reported Outcomes (PRO) in drug marketing authorizations

The PROLabels database (http://www.mapi-prolabels.org/) is a unique on-line tool which collects information on the medical and biological products for which the Food and Drug Administration (FDA) and/or the European Medicines Agency (EMEA) have granted a Patient-Reported Outcomes (PRO) labeling claim. It was co-developed by Mapi Research Trust and Mapi Values in 2006 and is currently managed and regularly updated.
The database was launched with the drugs approved in Europe through the centralized procedure established by the EMEA in January 1995 and with New Molecular Entities (NMEs) and Biological products (BLAs) approved by the FDA since January 1998.

Mapi Research Trust is pleased to announce that a large development plan has been undertaken to include, from 2008 on, all New Drug and Biological Approvals (i.e. NMEs, BLAs, revisions, efficacy supplements) in the database as soon as they are published on the FDA website. We have also started a retroactive review from 2007 and working backwards.

As of today, more than 230 products have been reviewed in the context of the development plan and 58 drugs approved with PRO labeling claims have just been added in the database. As a result, PROLabels currently contains 243 records representing 168 different molecules, on a total of 984 drug approvals reviewed for both the FDA and the EMEA. Overall (FDA + EMEA), the most represented therapeutic areas in PROLabels are currently nervous system diseases: 13.6%, immune system diseases: 12.2%, musculoskeletal diseases: 10.4%, skin and connective tissues: 9.7%, and respiratory tract diseases: 7.2%.
Additionally, thirteen instruments having received a PRO claim have recently been added in PROLabels, leading to a total of 74 PRO instruments present in the database as of March 2008.