PROLABELS™ was launched in 2006 to provide a global picture of Clinical Outcome Assessment (COA) endpoint strategies that are used to demonstrate the efficacy and safety of drugs or devices in the market approval process.
COA data is extracted from primary documents published by the FDA (e.g. product labels) and the EMA (e.g. European Public Assessment Reports (EPARs) – Product information (Summary of product characteristics). Additional documents such as Medical Reviews (FDA) and EPAR – Public assessment reports (EMA) are used to detail methods of assessment.
If at least one COA is mentioned in the efficacy or safety sections of the main documents, the corresponding medical product is described in PROLABELS™. For each medical product, information is summarized in five sections.
Regulatory documents: links to the authorization reports (i.e. product label, SPC) on the regulatory agency website.
Daily reviews include all drug approvals, revisions, and withdrawals. New releases from EMA and FDA are implemented within a month.
Drug approvals have been reviewed for Patient-Reported Outcomes (PRO) claims for EMA since 1995 and products from the FDA since 1939.
For all drugs approved since 2000, all COA types (PRO, ClinRO, ObsRO, PerfO) have been considered and described. For drugs approved before 2000, all PROs have been considered with a retrospective review still ongoing.