Clinical studies

The course of a clinical trial is subject to strict international standardization. Before the start of the study, the objectives of the study are formulated in a study protocol and the exact procedure is determined. In addition, safeguards for possible risks for trapped patients are developed. The study design must then be approved by the responsible ethics committee.

High demands are also placed on the scientific procedure. For example, in comparative therapy studies it is very important that sufficient and comparable patients participate. The exact number of participants required must be calculated by a mathematician. In order to avoid distortions, the participating patients are usually randomly divided into different groups (randomisation). Before participating in a study, patients must be fully informed and sign a consent form.

Clinical trials are classified as follows: In Phase I, a therapy is applied to humans for the first time and its tolerability is investigated. In the next step, phase II, the findings will be tested on a larger group of patients with the aim of determining the optimal dosage for the new treatment. In the Phase III study, a large group of patients is then tested to determine whether the new active substance or the new procedure is actually superior to the established treatment.

If you are interested in participating in a clinical trial, you will first be informed and educated by a physician.

At the same time you will receive an information sheet containing all essential information.

Only after you have given your written consent to participate in the study can you be included in the study.

Before, during and after the study you will be thoroughly examined by a doctor. This includes a complete physical examination, laboratory examination of blood and urine as well as an ECG and possibly a lung examination. You can take the values obtained in this way with you for your family doctor.

Participation in clinical trials as a volunteer is a responsible activity without which medical progress is not possible.

Subjects are healthy individuals or patients who volunteer to test new substances or medical devices in a clinical trial. All drugs or medical devices approved in Germany must undergo the legally prescribed clinical trials before approval in order to prove the quality, safety and efficacy of the new treatment principle.

For your participation in a clinical trial you will be paid an expense allowance, which is calculated from the time spent and the travel costs.

Surely you will only make yourself available as a volunteer if your integrity is taken care of during the study.

Every precaution shall be taken to minimise the risk:

• Compliance with all legal and voluntary protection regulations and close cooperation with the responsible ethics committee.
• Ongoing medical monitoring and control before, during and after study participation.
• Emergency guidance system in the hospital and emergency training of all study supervisors.
• The statutory insurance cover exists.
• The protection of your personal data is guaranteed.

In this phase, a drug is tested in studies with up to 100 participants.

Phase II trials are only open to patients who show the symptoms or disease to be treated by the new drug. In addition to the efficacy and harmlessness of the new drug, the tolerability and the relationship between the dose taken and the desired therapeutic effect are documented.

In phase III, the newly developed drug is tested in larger patient groups in comparison to an already approved drug or a placebo. In addition to tolerability and efficacy, side effects are of particular interest in Phase III. If the new drug is to be prescribed as long-term therapy for chronic diseases, patients must be treated over several months or years in Phase III trials.

If the drug is approved by the German or European authorities, the drug can be sold in pharmacies. Phase IV studies are being conducted to gain further experience with the drug and, in particular, to assess its tolerability over a long period of time.