Medical

A set of standard clinical chemistry and hematology parameters are usually measured during clinical studies. The major outcome of these standard tests is to control that the drug investigated does not lead to pathophysiological changes in respective organs or blood. In some cases based on scientific rationale such tests may not be needed. In this paper we report on a standard set of clinical chemistry and hematology laboratory parameters measured before and after treatment in three different immunotherapy studies, representing different routes of administration and different formulations. Thirteen hematological laboratory parameters and eight clinical chemistry parameters were evaluated from three double-blind, placebo-controlled, randomized, multi-centre, phase III studies. The three studies include one with sublingual immunotherapy (n = 185), one subcutaneous immunotherapy trial with an aluminium hydroxide-adsorbed recombinant hypoallergenic Bet v1-FV (n = 211) and one with pre-se...

Einleitung: Die SCIT wird schon seit Jahrzehnten erfolgreich mit nativen Extrakten durchgeführt. Ziel dieser Studie war es, die Sicherheit einer SCIT mit einer Mischung aus fünf rekombinanten Phleum pratense (rPhl p) Graspollenallergenen dosisabhängig zu untersuchen. Methoden: In einer[for full text, please go to the a.m. URL]

To cite this article: Gödicke V, Hundt F. Registration trials for specific immunotherapy in Europe: advanced guidance from the new European Medical Agency guideline. Allergy 2010; 65: 1499–1505.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.