Clinical Research
Without clinical research there can be no new drugs. It normally takes between 10 and 15 years from
the discovery of a promising compound right through to drug approval. The term “clinical trial” refers to
the final stages in the drug development process when a new drug or medical device is tested on
human beings.
Clinical research is concerned not only with the discovery and development of entirely new drugs,
but also with the constant improvement of existing treatments and the reduction of their side effects.
A new medication can only be licensed once its benefits, efficacy and tolerance have been proven in a
series of clinical trials. These clinical trials are conducted under strictly controlled conditions, in line with
numerous national and international regulatory guidelines, which ensure that the interests and safety
of patients always come first.
On successful completion of the trial cycle, the drug manufacturer files an application to the relevant
authorities (e.g. Federal Institute for Drugs and Medical Devices (BfArM) or the European Drug Approvals Authorities).
In addition to ensuring the safety of patients, quality assurance guidelines and regulations exist to ensure the validity of data collected in clinical trials. “Good Clinical Practice” (GCP), the Helsinki Declaration issued by the World Health Organization and EU recommendations stipulate minimum standards that clinical studies methods have to meet, and require that all findings, observations and conclusions are completely accountable.