About PROLABELS

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, indications, 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).
• 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.

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.

Clinical Study Details

• COA Results: efficacy studies results section only
• Design: summary of study characteristics e.g., number of patients, treatment arms, duration, etc.
• Study endpoints categorized per endpoint positioning and concept of interest. Endpoint definitions as well as the type of outcome assessment are provided for more details.
• Method of assessment: which COA is used and reported in the approved labeling and a link to PROQOLID™ instruments, if any.

Pharmacology

• Anatomical Therapeutic Chemical (ATC) Code of the drug: this classification, provided by the WHO (World Health Organization) divides drugs into different groups according to the organ or system on which they act and their chemical, pharmacological, and therapeutic properties
• Mechanism
• Therapeutic area(s): we use the MeSH (Medical Subject Heading) classification of diseases provided by the U.S. National Library of Medicine
• Therapeutic indication (general): this is the MeSH term equivalent to the term used in the source document
• Therapeutic indication (specific) as stated by the sponsor in the indication section

Application Details

• Marketing Authorization Holder: name and location
• Source of the data and approval identification number(s)
• Date of approval and, when relevant, the date of last available revision
• FDA Division
• COA Staff (Formerly the Study Endpoints And Labeling Development group: SEALD)

Information Sources

• Regulatory documents: links to the authorization reports (i.e. product label, SPC) on the regulatory agency website.

Related Therapeutic Indication(s)

• Links to other indications of the drug
• Links to other drugs' indications

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.