PRO Labels Database

PROLabels is a unique database, which summarizes the Patient-Reported Outcome (PRO) labeling claims granted by health authorities and published on their websites, starting with the FDA and the EMEA.

Each week the labels of new drugs and the variations of labels of approved drugs, are analyzed to look for PRO claims. For each product included, PROLabels presents the details of the claim, a summarized description of clinical trial data supporting the claim, and details of PRO instruments used. It also provides access to the source document ("Label" for the FDA and "Summary of Product Characteristics" for the EMEA). PROLabels can be searched by drug or sponsor name, therapeutic area, type of PRO, name of PRO instrument and year of approval.

The PROLabels database was developed by the Mapi Research Trust with the support and sponsorship of Mapi Values.  More information and access to the database can be found at: http://www.mapi-prolabels.org/