PROLABELS™ is a database listing drugs with Clinical Outcomes Assessments (COA) labeling results, which were approved by two major health authorities: European Medicines Agency (EMA) and US Food and Drug Administration (FDA).
The main objective of PROLABELS™ is to summarize all the evidence about COA results in the labeling of medical products for various disease areas, conditions, and manufacturers.
PROLABELS™ information is accessible through subscription.
PROLABELS™ provides a global picture of all the endpoints used to demonstrate the efficacy and other benefits of a product, if at least one COA is included in the label/EPAR study results.
PROLABELS™ includes an in-depth description of the efficacy clinical studies including the design, the results obtained, and the COA information. You will learn which concept of interest was assessed and how the concept of interest was evaluated.
EMA data: EMA publishes online reports for all the drugs approved according to its centralized procedure established since 1995. The European Public Assessment Reports (EPARs) of all approved drug products are examined with special attention to the Summary of Product Characteristics (SPC). Additional information is retrieved in the Scientific Discussion documents.
FDA data: FDA publishes online reports for all drugs approved in the United States of America. All product labels of New Drug and Biological Approvals (i.e. NMEs, BLAs, revisions, efficacy supplements) are examined. Additional information is retrieved in the Medical Review.
Once COA results are identified in the label, the corresponding medical product is described in PROLABELS™. For each medical product, information is summarized in five sections.
Our on-going reviews include all drug approvals, revisions, and withdrawals with weekly updates throughout the year.
EMA/FDA drug approvals have been reviewed for Patient-Reported Outcomes (PRO) claims since 1995. For other COAs (ClinRO, ObsRO, PerfO), the retrospective review is still on-going and information is up to date as of 2000.