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Clinical trials

The purpose of clinical trials is to examine the effectiveness of new ways of preventing, diagnosing and treating diseases. Until sufficient proof has been collected from many different studies, a new therapy remains an interesting prospect – nothing less, but also nothing more. However, the efficacy of a form of treatment must never be achieved at the expense of safety. In other words, the benefits of a therapy must always outweigh any possible detrimental effects. This is of decisive importance in all clinical trials.

Clinical trials are conducted according to a fixed sequence of stages, known as phases.

Preclinical studies are laboratory tests that are carried out before a new agent is tried out in humans. Substances under development that have potentially dangerous side effects or are not effective can already be identified and dropped at this point.
Phase I clinical trials are the first stage at which physicians study the active substance in humans. They test its safety and tolerability and how it behaves in the body. These studies are usually conducted on small groups of healthy test subjects.
In clinical trials II and III, large groups of patients are studied by physicians to determine the efficacy and safety of the new drug. Independent hospitals and physicians' practices in many countries are involved in clinical development.

Giving the general public access to information on clinical trials carried out on humans is normal procedure at Bayer HealthCare Pharmaceuticals. We publicize information on the status and the results of our own studies via Internet databases.