New treatment techniques or drugs must be carefully tested before they are regularly used on patients. For such clinical studies, there are strict requirements and defined procedures that must be followed in Germany. At our clinic, we conduct various such studies that either aim to perfect surgical procedures or optimize existing treatment approaches.
So, during your stay, we may ask you whether you would like to participate in a particular clinical study.
Your participation is voluntary. You can be absolutely sure that you will not be exposed to any unnecessary risks and that the entire course of the study will be constantly monitored by specialists. By participating, you would contribute to better treatment for patients suffering from the same disease in the future.
The causes of a large number of diseases are still not fully understood or are still unknown. Thanks to the almost complete decoding of the human genome, we are now able to track down the triggers and causes of various diseases. In the long term, this will allow us to develop better methods for preventing, detecting and treating diseases.
In order to study the correlations, we need tissue samples of healthy and diseased tissue, because only there can the actual changes be observed. If you have surgery, we would use parts of the removed tissue for research purposes. Of course, we need your consent for this. Therefore, before the operation we will talk to you and answer your questions. We thank you in advance for your valuable support.
In addition to patient care, research is one of our central tasks. The Department of General, Visceral and Transplant Surgery is very active in both clinical and basic research. Our goal is to transfer knowledge gained from basic research to all areas of patient care - from prevention to diagnostics and therapy.
Results from surgical clinical studies provide the basis for possible future therapy recommendations. If you would like to inform yourself and/or your patients about ongoing studies or even current study results, you can find information both on our websites and by contacting our study center directly. With the Clinical Study Center Surgery, the Clinic for General, Visceral and Transplant Surgery offers a large number of patients who are operated on in our clinic the opportunity to participate in a study and thus benefit from new therapy concepts.
Each year, approximately 400 patients are treated within the framework of clinical studies according to protocol; in the area of liver and kidney transplants alone, this number is currently over 40. Any study participation and the associated examinations for follow-up are noted accordingly in the discharge report, so that you are informed about the study participation of your patients and any queries can be clarified directly.
Should questions arise in the further course of treatment in relation to the study, you can contact us at the times indicated below.
KSC conducts both scientifically initiated studies (IIT = Investigator Initiated Trial) and contract studies for industry. The basis for conducting the studies are the criteria of Good Clinical Practice (GCP) and the applicable regulations such as AMG and MPG.
All studies are based on international guidelines such as ICH-GCP and the German Medicines Act and Medical Devices Act. Before patients can be included in a study, it must be reviewed by the Ethics Committee of Heidelberg University.
Studies developed by scientists can originate from the company's own clinic as well as from other clinics.