a unique online database on Patient-Reported Outcome claims in marketing authorizations


Patient-Reported Outcomes (PROs) are valuable endpoints used in clinical studies to assess treatment benefits from the patient perspective. PROLabels is a unique database which summarizes the PRO labeling claims granted by health authorities and published on their websites, starting with the FDA and the EMEA. PROLabels can be searched by therapeutic area, type of PRO, name of PRO instrument, year of approval, etc.

The PROLabels database provides:

Easy access to information regarding PRO claims for both FDA and EMEA in one location

Summary information and trends in PRO claims in the US and Europe

Researchers and manufacturers with strategic information about how competitors have differentiated their products based on PRO information

Potential guidance on designing trials in specific indications that include PRO endpoints

Go to the PROLabels website

The PROLabels database is a collaboration of: