Clinical studies and COVID-19
Clinical trial of a medicinal product:
These clinical trials serve to investigate the efficacy and safety of drugs, for example as vaccines, treatment of infection or treatment of secondary diseases. An application for clinical trials must be submitted to the BASG and the responsible ethics committee. You can find all further information on the application modalities here.
Clinical trial of a medical device and performance evaluation of an in-vitro diagnostic device:
These Clinical Trials serve to investigate the performance and safety of medical devices and in-vitro diagnostic (IVD) agents, for example as tests for viral infection or viral antibodies. An application for a clinical trial or performance evaluation must be submitted to the BASG and the responsible ethics committee. All further information on the application modalities can be found here.
Compassionate use of a drug:
Compassionate use offers the possibility of providing patients with unapproved drugs when there is no adequate treatment is available and when they are not suitable for inclusion in a clinical trial. An application for Compassionate Use must be submitted to the BASG. All further information on the application modalities can be found here.
All applications for clinical trials or compassionate use with relevant products are validated and evaluated as a priority. The legal and scientific requirements for the protection of patients still apply.
A "Heilversuch" is the administration of an unauthorised product to a specific individual patient within the framework of therapeutic freedom. It is therefore also referred to as "Named Patient Use".
Named Patient Use is not clinical research, but serves solely for medical treatment. A systematic collection of data on the safety and efficacy of a medicinal product within the framework of a "Heilversuch" is therefore not permitted and is only possible within the framework of a clinical trial.
In Austria, the conduct of a "Heilversuch" is not subject to authorisation by or notification to the authorities, but is the personal responsibility of the treating physician! Further information on the difference between Compassionate Use vs. Named Patient Use can be found here.
Further information on the supply of drugs for COVID-19 therapy outside of clinical trials and compassionate use can be found here.