International Clinical Trials Day takes place annually on the 20th of May and draws attention to the importance of clinical trials for the development, authorisation, and monitoring of medicinal products. Clinical trials are designed to test the tolerability and efficacy of new medicinal products. Phase I through III clinical trials are carried out before a medicinal product receives marketing authorisation and is placed on the market. A phase I trial provides information on the initial introduction into humans with a small number of trial participants. Phase III trials may involve several thousand trial participants. Clinical trials may be carried out even after authorisation in what are known as phase IV trials. One purpose of a phase IV trial is to collect additional information on rare side effects. All clinical trials in Germany must be approved by the competent higher federal authority – depending on the medicinal product, either the Federal Institute for Drugs and Medical Devices (BfArM) or the Paul-Ehrlich-Institut. In addition, there must be a positive assessment from an ethics committee formed in accordance with state law. As of January this year, applications must be submitted centrally via the European Clinical Trials Information System (CTIS).
The Paul-Ehrlich-Institut is the German authority responsible for the approval of clinical trials in the field of vaccines and biomedicines. A clinical trial may only be carried out in Germany if the experts at the Paul-Ehrlich-Institut have issued an approval after examining the application and the opinion of the competent ethics committee. Since the entry into force of the EU Clinical Trials Regulation (CTR), applications for clinical trials in the European Economic Area (EEA) must be submitted through the European Clinical Trials Information System (CTIS). CTIS acts as a central interface for clinical trial sponsors applying for approval of a clinical trial and for the medicines authorities and ethics committees evaluating those applications.
The Paul-Ehrlich-Institut's processing statistics on clinical trials in the field of vaccines and biomedicines show that the number of applications has increased significantly, from 44 in 1995 to 416 in 2022. Monoclonal antibody medicinal products have made up the largest proportion of clinical trials by far for years. Between 2004 and 2022, 65.7% of clinical trials applications were submitted for monoclonal antibodies, followed by applications for clinical trials of vaccines (7.8%).
Through its regulatory work, the Paul-Ehrlich-Institut contributes to the protection of trial participants and supports the development of new, innovative medicinal products.
Updated: 19.05.2023
