Procedure of a clinical study

Clinical studies always follow a similar pattern.

If you inform us that you are interested in participating in a study, you will receive information from one of our investigators. He will inform you, for example, as to what exactly is being investigated and what it means for you exactly. He will explain to you the possible discomfort as well as the benefits you can expect from participating in the study. He will inform you of the insurance coverage of all participants and about your right to end participation in the study at any time without giving reasons. Then you can take your time and decide for or against participation. If you decide you wish to participate, the procedure is as follows . . .

Initial examination:

The physician will examine you thoroughly and establish if you can actually participate in the study. He will examine in particular whether you are suffering from the disease involved in the study and if there are any health risks involved for you or you have any other diseases that the participant must not have. This initial examination serves to keep the risk for you as a participant as low as possible, and to ensure that the study provides useful results.

Course of the Clinical Study:

And now the actual study begins. In some studies it may be your task to keep a patient diary. This would record, for example, the time of taking drugs,and any physical reactions. To ensure that your participation contributes to better treatment for patients concerned, it is very important that you carry out tasks exactly as instructed by the physician.

You are now examined at specific intervals. These examinations usually take place more frequently and are much more exact than normal examinations. They are to ensure that the item being tested is doing you good. If you no longer wish to participate in the study, you can revoke your consent without specifying any reason, and discontinue participation. However, it is important that you inform your physician of such a decision immediately, and do not simply discontinue taking the study drug.

The Final Examination:

At the end of the planned treatment period you will be thoroughly examined again by one of our physicians. Your state of health will be recorded precisely, and compared with your condition at the start of the study.