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Worldwide Clinical trials Germany

In 2011, Germany and France approved approximately the same number of oncology clinical trials, but the number of cardiovascular trials approved in Germany was nearly double that in France.

A review of ClinicalTrial.gov data shows Germany leads all European nations in open multinational (interventional) clinical studies for cardiovascular, hypertension, stroke or congestive heart failure.

According to The Heart Research Center Göttingen, which investigates the mechanisms that lead to heart diseases and the aggravation of already existing heart diseases, two to three million people in Germany are affected by heart failure. The 5-year mortality rate is about 50 percent (higher than in most cancer diseases).

As part of the European Union (EU), clinical trial approval processes in Germany are standardized, reliable, transparent, and allow for relatively short study start-up timelines. Personnel at the German competent authorities (regulatory agencies) are knowledgeable, efficient, and experienced, and they often collaborate with academic researchers who are global opinion leaders in their fields.

Germany has two regulatory authorities with separate responsibilities. The Federal Institute for Drugs and Medical Devices (BfArM) is responsible for clinical trials with drugs and medical devices, while the Paul Ehrlich Institute (PEI) is responsible for vaccines, medicinal products containing antibodies, allergens for therapy and diagnostics, blood and blood products, tissue and medicinal products for gene therapy, somatic cell therapy and xenogenic cell therapy.

The German government invests in health care and biomedical research, providing EUR 1.2 billion for R&D projects in this sector through 2011.However, pharmaceutical companies fund 70% of all clinical trials performed in Germany.

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