How is the PROCEDURE OF A CLINICAL STUDY?
After a personal pre-study discussion with one of the doctors of the study, an initial screening is carried out. The physician inquires the patient's medical history. Then a first thorough examination is made, in which it is determined whether the patient actually suffers from the disease to be investigated. In addition, it is to be excluded that there are health risk factors or other diseases which are opposed to participation in the study.
On the basis of this examination, the doctor finally determines whether the subject can participate in the study. This ensures that the therapy is carried out only with suitable subjects and can therefore lead to usable results.
In this interview, the participants will also be informed in detail about benefits and possible risks of the study. There is adequate insurance cover.
At the start of the actual clinical trial, the participant receives the test preparation which has to be used in the prescribed form. At regular intervals, follow-up examinations will be scheduled, usually taking place more frequently than the normal dermatologist visits at the beginning of the treatment. This way, we want to ensure that the preparation to be tested is used successfully and does not cause harmful side effects.
In some studies, the participants also maintain a patient journal in which certain data needs to be noted regularly, such as time of administration, subjective and objective state of health and medical visits.
After the prescribed treatment time, a final control examination is carried out. The health condition is documented in detail and compared with the status at the beginning of the study. The participants are then monitored for a certain additional time. This is a further check whether the treatment was successful.
At the end of the study the participant receives a doctor's report for possible further treatment by the doctor or dermatologist. If at a later stage a follow-up study suitable for the clinical picture is carried out, subjects can also participate in this.
As a general rule, anyone who no longer wishes to participate in the course of the study can revoke his consent at any time without giving reasons and terminate the participation. This should be discussed in advance with the investigator.
On the basis of this examination, the doctor finally determines whether the subject can participate in the study. This ensures that the therapy is carried out only with suitable subjects and can therefore lead to usable results.
In this interview, the participants will also be informed in detail about benefits and possible risks of the study. There is adequate insurance cover.
At the start of the actual clinical trial, the participant receives the test preparation which has to be used in the prescribed form. At regular intervals, follow-up examinations will be scheduled, usually taking place more frequently than the normal dermatologist visits at the beginning of the treatment. This way, we want to ensure that the preparation to be tested is used successfully and does not cause harmful side effects.
In some studies, the participants also maintain a patient journal in which certain data needs to be noted regularly, such as time of administration, subjective and objective state of health and medical visits.
After the prescribed treatment time, a final control examination is carried out. The health condition is documented in detail and compared with the status at the beginning of the study. The participants are then monitored for a certain additional time. This is a further check whether the treatment was successful.
At the end of the study the participant receives a doctor's report for possible further treatment by the doctor or dermatologist. If at a later stage a follow-up study suitable for the clinical picture is carried out, subjects can also participate in this.
As a general rule, anyone who no longer wishes to participate in the course of the study can revoke his consent at any time without giving reasons and terminate the participation. This should be discussed in advance with the investigator.