• Clinical study details: The labeling claim content (PRO studies results as published in the source document), design of the study, study endpoints (primary endpoint, PRO endpoints in approved labeling and PRO endpoints not reported in label), PRO information (which kind of PRO was assessed, which PRO measure(s) was(were) used, with a brief description of PRO instruments and links to additional information if available)

• Pharmacological action details: ATC Code and Pharmacotherapeutic group, Therapeutic area, Therapeutic indications (general and specific)

• Application details: Approval number, company name and location, date of approval, date of last label revision, FDA division and involvement of Study Endpoints And Labeling Development group (SEALD)

• Information sources: Source of the data (FDA or EMEA), links to the authorization reports

• Selected bibliographic reference(s): retrieved from PubMed

This on-going extension of the FDA coverage for the PROLabels database allows a clearer picture of the use of PRO endpoints and their acceptance to assess treatment benefit.
Overall, the PROLabels database provides:
- Easy access to information regarding PRO claims and the instruments used as endpoints to support the claims in approved labels for both the FDA and EMEA in one location
- Summary information and trends in PRO claims in the US and Europe
- Researchers and manufacturers with strategic information about how competitors have differentiated their products based on PRO results. The database also informs on successful trial designs including PRO endpoints.

PROLabels is available through annual subscriptions from pharmaceutical companies. For more information, please contact:

Marie-Pierre Emery
Director of the Information Resources Centre
Mapi Research Trust
Lyon, France
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