title: Registration trials for specific immunotherapy in Europe: advanced guidance from the new European Medical Agency guideline.
abstract: Marketing authorization of medicinal products is granted based on results of registration trials. The European Medical Agency (EMA) has issued general and disease state-specific guidelines for the conduct of such trials. In the area of allergic diseases, there are basically two general therapeutic approaches: Drugs that mitigate the symptoms and an approach that is targeted to the root cause of the disease, the allergen-specific immunotherapy (SIT). While the 'Guideline on the Clinical Development of Medicinal Products for the Treatment of Allergic Rhino-Conjunctivitis' (CHMP/EWP/2455/02) and the 'Note for Guidance on the Clinical Investigation of Medicinal Products in the Treatment of Asthma' (CPMP/EWP/2922/01) focuses exclusively on the development of medicinal products to treat allergic symptoms, there was no guideline for SIT in the past. In consequence, the conduct of clinical trials for SIT was widely lacking a standardized approach. This created difficulties when comparing drugs and outcomes and also uncertainty to predict marketing authorization. In 2009, the EMA has issued a new guideline on the clinical development of products for SIT. Despite some white spots in some areas, the new guideline constitutes a breakthrough with regard to guidance, harmonization and transparency in the conduct of clinical trials in SIT.
authors.affiliation: Faculty of Medicine, University of Duisburg-Essen, Essen, Germany. Viola.Goedicke@gmx.de
authors.forename: V
authors.initials: V
authors.lastname: Gödicke
authors.forename: F
authors.initials: F
authors.lastname: Hundt
mesh_terms: D000485:Allergens / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D003888:Desensitization, Immunologic / Q000379:methods / Q000592:standards*; D005060:Europe; D006801:Humans; D006967:Hypersensitivity / Q000628:therapy*; D017410:Practice Guidelines as Topic
chemical_list: D000485:Allergens