About PROLABELS

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.

Objectives:

• To quickly identify competitors landscape
• To provide up-to-date information on COAs mentioned in labels
• To support a successful endpoint strategy in a drug 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.

Clinical Study Details

• COA Results: COA results reported in the efficacy or safety section
• Design: summary of study characteristics e.g., number of patients, treatment arms, duration, etc.
• Study endpoints categorized per endpoint positioning and concept of interest measured by a COA. Endpoint definitions as well as the type of COA are also provided.
• Method of assessment: which COA is used and reported in the approved labelling with a link to the COA description in PROQOLID™, if available.

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 Labelling 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 the drugs' other indications

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.