Clinical studies
In our Clinical Department of Gastroenterology, Hepatology, Infectious Diseases and Endocrinology, we conduct ongoing Phase I - IV clinical trials to improve treatment options for our patients. Clinical trials are carried out to test how effective, tolerable and safe a drug is or to compare different treatment or examination methods. In order to answer scientific questions and improve medical treatment, we conduct studies in the areas of hepatology, chronic inflammatory bowel diseases, gastrointestinal tumor diseases, liver transplantation and endocrinology. Our functional areas of sonography and endoscopy also carry out clinical studies in order to develop new diagnostic and therapeutic procedures. Our Clinical Department is involved in numerous national and international multicenter studies and also has many years of experience in conducting its own IITs (investigator initiated trials).
Our study outpatient clinics
If you are interested in treatment within a clinical trial, please contact the relevant specialist outpatient clinic:
- Outpatient hepatology: Study outpatient clinic → Tel. 0511 532-3850, -3779, -5702
- Chronic inflammatory bowel diseases → Tel. 0511 532- 3160
- Transplant outpatient clinic for liver → Tel.: 0511 532-6306
- Gastroenterological oncology outpatient clinic → Tel. 0511 532-6779
- Endocrinology outpatient clinic → Tel. 0511 532-4148
Senior Consultant Head of Clinical Studies
Prof. Dr. med. Katja Deterding
Tel.: 0511 532 3850; - 3779; - 5702
Have we piqued your interest?
In order to give you the opportunity to inform yourself in advance about the conduct of clinical trials, we would like to provide you with some information below.
What is a clinical trial?
Before a new drug is admitted for prescription, proof of its efficacy and safety must be provided. Doctors and Clinical Departments that conduct clinical trials have special expertise in this area and must demonstrate certain qualifications. For new drugs, there are strict regulations and defined procedures that must be followed before they can be used on patients.
There are different types of drug trials. Once a new active ingredient has been developed, it is first tested intensively in the laboratory and then on animals. Only if this active ingredient has proven itself there and has been shown to be safe may it then be tested on humans. These studies are then divided into phase I, phase II, phase III and phase IV:
In phase I studies, a therapy is applied to humans for the first time. In this phase, the tolerability of a drug is tested. Healthy volunteers test the active substance in this phase for tolerability and how the active substance is absorbed in the body, what concentrations of the active substance are reached in the blood and how the active substance is broken down and excreted in the body.
In phase II studies, the new drug is used on patients for the first time. This phase examines whether the drug is effective, whether it is well tolerated and which dosage is best for treating the disease. The optimal dosage range for the drug is then determined based on the results of the phase II trials.
Phase III studies are the final step in testing the efficacy and safety of a drug on a large number of patients worldwide before admission. In this phase, particular attention is paid to rarely occurring side effects. If the drug has also proven its efficacy and safety in this phase, the manufacturer can apply to the authorities for admission of the drug. As soon as the authorities have approved the drug, it can be prescribed by a doctor on a prescription.
Phase IV studies are conducted to gain further experience with the approved drug and to assess its tolerability over a long period of time. Furthermore, it is often investigated whether the drug can be used for patients with certain concomitant diseases or how it can possibly be combined with other drugs.
The course of a clinical trial is subject to strict international guidelines. Before a clinical trial begins, it is reviewed by an ethics committee. The ethics committee weighs up the benefits and potential risks of a study. The ethics committee also checks the qualifications of the medical staff and the medical facility where the study is to be conducted. Only after reviewing all documents does the ethics committee give its approval to conduct a clinical trial.
Before inclusion in a clinical trial, all patients receive patient information or a declaration of consent. This explains in detail the aim, procedure, benefits and risks as well as possible side effects of a clinical trial. As a patient, you will be given sufficient time to decide whether or not to participate in a clinical trial. If you have decided to participate, you confirm this by signing the declaration of consent.
The inclusion examination will then check whether you meet the inclusion criteria for the clinical trial. If all inclusion criteria are met and no exclusion criteria were found, you will then be examined at the appointments specified in the study protocol. During these check-ups, we will check whether you tolerate the medication well and whether any side effects occur. The patient's state of health will be monitored particularly carefully during participation in the study.
In the context of a clinical study, it is ensured that no one other than the treating medical staff can recognize from the data collected in the study from which person the data originates. The patient is given a pseudonym in the study under which all data is collected. Strict data protection regulations apply to the storage and analysis of clinical data. In addition, all persons involved in the study are subject to a duty of confidentiality.
Randomization means that the study participants are randomly assigned to the treatment groups planned in a clinical trial. This is to ensure an objective allocation and to guarantee that not only the "sicker" or "older" patients are grouped together in one of the study groups. Otherwise, the results of the individual treatment groups would not be comparable.
In some studies, placebos that do not contain an active ingredient are also used as a control group for the new drug, so that actual drug effects can be differentiated. These studies are double-blinded, which means that neither you as the patient nor the medical staff treating you know whether you are receiving the correct medication or a placebo during the clinical trial. The blinding prevents personal impressions and expectations or external influences from distorting the study results.