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Last updated 2 April 2008
- What are the PROLabels information sources?
We analyse the information disclosed by the US Food and Drug Administration and by the European Medicines Agency on their respective websites (http://www.fda.gov/cder and http://www.emea.eu.int ).
Up to now, we have analysed European Public Assessment Reports (EPARs) reviewed by the EMEA through the centralised procedure since 1995, New Molecular Entities (NMEs) approvals available from the FDA since 1998 and Biological Products (BLAs) approvals available from the FDA since 2004. In addition, we have undertaken a large development plan to include, from 2008 on, all New Drug and Biological Approvals (i.e. NMEs, BLAs, revisions, efficacy supplements) in the database as soon as they are published on the FDA website. We have also started a retroactive review from 2007 and working backwards.
- What are the PROLabels inclusion criteria?
From the FDA website, the last available drug label is reviewed to search for PRO claims in the Clinical studies section. In case of doubt, the corresponding Medical Review is referred to make sure that the measure involved a PRO (when available).
From the EMEA website, we review all Summary of Product Characteristics (SPC) to search PRO efficacy endpoints in the 5.1. Pharmacology section, and gather additional information from the Scientific Discussion when necessary.
- What is a PRO (Patient-Reported Outcome)?
We use the FDA's definition : "Any report coming directly from patients about a health condition or treatment" (from FDA 2006, Draft Guidance for Industry. Patient-Reported Outcomes measures: use in medical product development to support labeling claims.)
Therefore, even objective data recorded by the patients will be found here (such as Forced Expiratory Volumes, etc.). We also include proxy- and caregiver-reported measures, especially to take into account the cases when the patient is not able to self-report, such as pediatric studies or mental disorders.
On the other hand, results collected with interviewer-administered instruments, as well as clinician-reported evaluations will not be found in this database.
- What about the composite endpoints?
We include a drug evaluated with a composite endpoint as long as at least one of the component is a PRO. Examples of these include the ACR20 (American College of Rheumatology 20% response index).
- What's the difference between Bibliographic references in the Information Sources section and Selected bibliographic references?
The bibliographic references in the Information Sources section are from the primary documents, when available. The Selected bibliographic references are an additional information provided to complete PROLabels and provide related links. These references are retrieved from PubMed with the criteria of dealing with the same or different clinical studies involving the drug of interest in the same therapeutic indication, and where PROs have been used.
- What is the therapeutic classification used in PROLabels?
From the therapeutic indication of the drug present in the documents posted on the health authorities websites, we search for the equivalent MeSH term using the online MeSH browser, (available at http://www.nlm.nih.gov/mesh/meshhome.html).
The MeSH term is further classified under different diseases headings which were retrieved to fill in the therapeutic area entry of the database. The MeSH Diseases used in PROLabels are listed below. Please note that a drug may be classified under different headings.
- Anesthesia and Analgesia
- Bacterial Infections and Mycoses
- Behavior and Behavior Mechanisms
- Behavioral Disciplines and Activities
- Cardiovascular Diseases
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Dentistry
- Diagnosis
- Digestive System Diseases
- Disorders of Environmental Origin
- Endocrine System Diseases
- Eye Diseases
- Female Genital Diseases and Pregnancy Complications
- Hemic and Lymphatic Diseases
- Immune System Diseases
- Investigative Techniques
- Mental Disorders
- Musculoskeletal Diseases
- Neoplasms
- Nervous System Diseases
- Nutritional and Metabolic Diseases
- Otorhinolaryngologic Diseases
- Parasitic Diseases
- Pathological Conditions, Signs and Symptoms
- Psychological Phenomena and Processes
- Respiratory Tract Diseases
- Skin and Connective Tissue Diseases
- Surgical Procedures, Operative
- Stomatognathic Diseases
- Urologic and Male Genital Diseases
- Virus Diseases
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