About PROLABELS™

PROLABELS™ describes drugs with Clinical Outcome Assessment (COA) results available since 1995 on the European Medicines Agency’s (EMA) website and on the US Food and Drug Administration’s (FDA) website.

Objectives

The main objective of PROLABELS™ is to summarize all the evidence about COA results in the labeling of medical products for disease areas, conditions, and manufacturers.

Database Content and Information Sources

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. 

The database 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, in addition to a brief description of any instrument that was used.

PROLABELS™ database is updated once a week in order to give you the latest comprehensive information on medical products. This update includes new marketing authorizations published on the FDA and EMA websites as well as variations of already approved products.

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). To complete our records, clinical studies which included COA endpoints (whether primary or not) are searched and, when necessary, additional information in Scientific Discussion documents is retrieved.

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 as soon as they are published on the FDA website. Additional information in the Medical Review is retrieved when necessary.

Results Display

Once COA results are identified in the label, the corresponding medical product is included in PROLABELS™. Then the record is completed by summarizing the following information in five sections.

Clinical Study Details

• 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.
• Outcome assessment: which COA is used and reported in the approved labeling and a link to PROQOLID™ instruments, if any.
• Additional COA (not reported in the approved labeling)

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

Additional functionalities:

• ePROVIDE™ gives you the opportunity to access PROQOLID™ instruments related to the drug, and guidances related to the same therapeutic indication
• You can access the list of therapeutic indications by clicking the “See more” button;
• Click on the “i” button and  access to the list of concept of interest and the type of outcome assessment for free (before member access);

Quality Check

The definition of the inclusion criteria was performed by Marie-Pierre Emery, MSc (Associate Director of Mapi Research Trust) and Catherine Acquadro, MD (Scientific Advisor at Mapi Research Trust) with the support of Donald L. Patrick, PhD, MSPH.

A quality check of the database is performed on a regular basis.

Some specific diseases or therapeutic areas, like neoplasms, psoriasis… have been specifically reviewed.

[References used for the cancer drugs review:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071590.pdf
http://www.fda.gov/downloads/Drugs/NewsEvents/UCM445870.pdf]

Contact Us

Your suggestions and comments are most welcome, to ensure that PROLABELS™ better meets your needs.