Paul-Ehrlich-Institut

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Clin­i­cal Tri­als

The purpose of a clinical trial is to demonstrate the efficacy of a medicinal product candidate and to determine its safety and tolerability. Phase 1, 2, and 3 clinical trials are conducted before a medicinal product is authorised and allowed to enter the market. Phase 4 clinical trials are conducted post-authorisation as needed.

Clinical trial procedures are strictly regulated. The ethical and legal conditions that apply to clinical trials ensure protection of study participants' rights and safety. Quality assurance measures for the conduct of clinical trials in accordance with Good Clinical Practice (GCP) ensure compliance with the ethical and legal conditions and reliability of the clinical trial results.

Each clinical trial for vaccines or biomedicines to be conducted in Germany must first receive a positive vote from the responsible ethics committee and receive a positive evaluation and approval from the Paul-Ehrlich-Institut, which takes the vote of the ethics committee into account.

Infographic on clinical trials (Source: Paul-Ehrlich-Institut)

Infographic: Clinical Trials

The data from the clinical trials makes up a large part of the marketing authorisation documents. It is submitted by the applicants along with their authorisation application. The data evaluation follows scientific principles and determines whether the medicinal product in question meets the requirements for quality, safety, and efficacy in accordance with national and EU legislation.

Regardless of the country in which the clinical trials are conducted, if the data collected in these clinical trials is included in marketing authorisation applications for medicinal products for human use in the European Union (EU) or in the European Economic Area (EEA), the trials must comply with EU clinical trial legislation (pursuant to Directive 2001/83/EC, Annex 1). Clinical trials must comply with all relevant ethical principles, including compliance with Good Clinical Practice and the Declaration of Helsinki.

Before issuing an opinion on the authorisation of a vaccine or other biomedicine, the Paul-Ehrlich-Institut independently assesses the results of the data obtained from the clinical trials by pharmaceutical companies and non-commercial sponsors.

Extensive information on clinical trials in the EU is published in databases that are accessible to the public. There are two European databases that collect information on clinical trials: the EudraCT database (primarily for past clinical trials) and the Clinical Trials Information System (CTIS).

Contact

Section Clinical Trials
Email: ct@pei.de

Updated: 05.01.2024