[Clinical post-approval studies as part of the Therapy Allergen Regulation (TAV): A systematic review]

With the introduction of the Therapy Allergens Ordinance (TAV) the previously unapproved therapeutic allergens on the existing market need to be checked for their risk-benefit ratio as a basic prerequisite for approval under pharmaceutical law. This process is criticized because it can lead to long transition periods so that patients will probably be treated for two decades with preparations whose effectiveness has not yet been proven and may never be proven. The aim of this work is to list the critical preparations for which no publicly accessible study activity has been recorded since the beginning of the TAV in 2008. For this purpose, the European Clinical Trials Register (clinicaltrialsregister.eu) and the American study register (ClinicalTrials.gov) are systematically searched. The following hypothesis, consistent with the TAV, will be checked: "In the past years, study programs were carried out for the preparations in the process of the TAV - the majority of these preparations are about to be approved by PEI". The hypothesis is refuted with the findings of this work. In fact, no preparation can currently be identified that is about to be TAV approved. 61 preparations are currently in the TAV process; only two preparations have already passed this successfully. If the total of 63 (61+2) preparations are combined in the homologous groups - trees, grasses, mites and mixtures -, there are 33 preparations that can be classified as follows: For the 33 preparations in the TAV process, 36 studies (phase II and III) that may potentially be relevant for TAV were found as part of the screening. For 15 of these studies the results have duly been entered in the European study register. The results of another 13 studies have not been stored in the study register although they are marked as completed. No information has been stored in the European study register for four studies so that the status of these studies remains unclear. Four studies have not yet been completed. Responsible doctors can make recommendations for the prescription of a certain SIT preparation only if there is adequate evidence of its effectiveness. For preparations that have not yet started studies more than ten years after the introduction of the TAV, it is very doubtful whether approval can still be obtained or whether it is even being sought. For the three main inhaled allergens (grasses, trees and mites) there is already a selection of approved, evidence-based and effective alternatives for both subcutaneous (SCIT) and sublingual (SLIT) application from various manufacturers on the market. The use of therapies that have been approved and proven effective is essential in terms of guideline-compliant, sensible care for patients.