The investigation plan for clinical studies names certain acceptance and non-acceptance criteria for participating, such as e.g. age, gender, nature and stage of illness, treatment made so far, and potential additional illnesses. Some studies are also looking for healthy participants. Prior taking of certain medicine can be of importance, too. These criteria serve the patients‘ safety and correctness of findings.

A new treatment not yet accessible to the broader public might be applied to the participants. This might be a great chance for seriously ill patients in particular. Moreover, they can make use of medical treatment brought uptodate with medical knowledge. Medical care is much tighter and more intensive than outside studies. Last but no least, participants contribute to medical progress thus helping other patients.

Security of participants has top priority when carrying out clinical studies. In Europe, it is ensured by the guidelines of GCP (Good Clinical Practice) and detailed instructions. According to these, low doses are tested to start with that will be gradually increased. By doing permanent and careful checking, investigators make sure that side effects are realized at once and that treatment is stopped immediately in case of need. Before starting a study, qualified national institutions such as the ethic‘s committee, check whether patients might be exposed to risks that cannot be justified medically. Even during the course of a study, the ethic’s committee could withdraw its approval e.g. due to side effects arising.

An application for approval has to be made with the Federal Institute for drugs and medical products (BfArM) for each clinical study. This can only be done after completion of a comprehensive pharmacological and toxicological investigation. This application contains the results of pre-clinical studies, investigation plan, patients‘ information, declaration of approval as well insurance confirmation. All documents are being checked with a view to their harmlessness, understandability and legal points of view. Moreover, the documents and qualification of investigators and study centres is checked by the competent ethic’s committee consisting of medical experts, a jurist and a medical layman. Only upon receipt of the ethic’s committee’s and federal institution’s approval, a study can start. 

Before a participant declares his approval, he will be exactly informed by the investigator regarding the course of the study, the use and the risks related thereto. This information is given to the participant in written form, too. Of course, the patient has the possibility to clarify all his questions with the doctor. The participant will also be informed about passing of data within a study which are absolutey confidential and subject to data protection.