This content is relevant for:Coronavirus / Medical Biotechnology / Pharmaceuticals
Your company is already operating in Germany and you would now like to export worldwide?
After the outbreak of the Covid-19 pandemic, medical researchers around the world engaged in a rapid, large-scale response to develop urgently needed treatments for the infection. Clinical studies play a key role in bringing research progress to patients.
Germany has been a very active location in the clinical development of drugs and other treatments.
As of October 14, 2020, there were 97 Covid-19 clinical studies registered at sites in Germany. Forty-seven percent are interventional studies (i.e. clinical trials). Nineteen of these trials are in Phase III or II/III. Because many of the treatment approaches for Covid-19 are based on drugs already approved for other indications, a large number of development projects are already at an advanced stage.
Forty-six percent of the clinical trials are industry sponsored, with the remainder being mostly carried out by the over 40 university hospitals in Germany. These clinical trials highlight the degree to which the global Coronavirus response is a team effort: On average, 2.5 parties per trial are involved either as sponsors or as collaborators, and sometimes as part of an international collaboration.
Clinical research in Germany pursues a broad range of therapeutic approaches: One-third of the trials investigate drugs with anti-inflammatory or immunomodulatory function, many of which are aimed at alleviating the pulmonary symptoms resulting from the body's immune response to the virus. These pharmaceuticals are mostly compounds already approved for another indication that are now being repurposed for Covid-19 treatment.
Thanks to their head start in development, these assets have the potential to be available for routine use relatively fast.
Thirty percent of the trials investigate products that tackle SARS-CoV-2 directly rather than addressing the symptoms: examples being antivirals, such as remdesivir, and vaccines (including convalescent plasma). This includes RNA vaccines that were developed in Germany and have made headlines worldwide: CureVac's Covid-19 vaccine is currently studied in a Phase IIa trial in South and Central America. The mRNA immunisation is developed in collaboration with the Coalition for Epidemic Preparedness Evaluation, an organization that received additional funding as part of the German economic stimulus package in June.
BioNTech's BNT162 vaccine is also being evaluated in a Phase II/III trial in numerous sites in the US and other countries. Its development is carried out in collaboration with Pfizer and Fosun Pharma, and early data from the ongoing trial might be available as early as October 2020.
Other trials evaluate a variety of other interventions including
Nearly all of the registered clinical trials at sites in Germany are still ongoing, and more than half of them are expected to complete data collection before the end of 2020. Collectively, the enrollment of over 93,000 volunteers is planned across all clinical studies in Germany – that is over 950 persons per trial on average.
Thanks to its population size and excellent healthcare infrastructure, Germany is a very attractive clinical research location - not only during a pandemic response.