Clinical Trials

Medical research projects focus on various new treatment options. Based on the fact that these clinical trials require much experience, they are usually done at university hospitals or at a center for tumor diseases. The trials take place in consecutive phases:

Phase I: In this first phase, only few patients take part in testing new drugs or substances that have been previously tested only in the laboratory and in animal models. Patients participating in a clinical trial at such an early phase usually have no other treatment option any more, thus testing a new therapy implies a chance for fighting their cancer.

Phase II: In this second phase, several hundreds of patients take part. The new treatment option or the new drugs or substances are to be further tested, especially regarding tolerance. The results of this phase will determine whether or not the testing will be continued. In case a new drug proves to be effective already in phase II and if no other treatment option exists so far, a market authorization can be given.

Phase III: In this third phase, several thousands of patients take part. The new therapy is further tested and judged and is compared to present therapies. The market authorization of a new drug will be given after the ending of phase III, if adequate results are on hand.

Phase IV: This fourth phase takes place after the market authorization of a drug, in order to further control and secure the treatment.

Before starting a clinical trial, extensive precautionary measures have to be taken. Only a physician experienced in clinical trials is allowed to lead the study. A strict study protocol determines the guidelines for the clinical trial, and the ethics committee of the university has to approve it before the trial can actually start. This ethics committee consists of scientists, physicians, church representatives and other responsible persons. First priority is always to ensure the protection of the participant, to assure data privacy and medical confidentiality. After discussing all questions, the participant has to sign an informed consent document. Still every participant may withdraw from the trial at any time and without giving any reason. Participating in a clinical trial always implies a best possible and extensive medical care based on high international standards.

According to the random principle, the participants get divided in one standard group and one control group. The drugs of both groups are neutrally packed. If neither patient nor physician knows of which group the patient is part of, this study is called double-blind. If only the patient is unaware of which group he is part of, this is called single-blind.

Here you will find various links to current studies on colorectal cancer.

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