Subjects

These pages contain information on clinical trials, what happens in them and how you can take part in one as a subject.

Clinical research and medical advances simply would not be possible without the subjects who volunteer for clinical trials. You can contact us at any time if you would like to be a subject in a trial.

You can find our questionnaire for registering as a subject here.

The trials for which we are currently seeking subjects are listed here.

What happens in a clinical trial

Before a subject takes part in a trial, they are first invited for a preliminary interview to give them detailed information about it. After giving the subject sufficient time to consider their decision and obtaining their written consent, a physical examination and, if applicable, further tests (e.g. bloods) can be used to determine whether they are capable of taking part in the relevant trial. The subject is then asked to come to our ward at the start of the trial, where an intravenous cannula is usually fitted and a blood sample taken. In a pharmacological trial, the participant will receive the first dose of the drug to be administered, which will either be the therapy being trialed or a comparator drug. In some cases, neither the physician nor the subject will know who has been placed at random in which group (“double-blind study”). Depending on the nature of the trial, several blood samples may be taken via the intravenous cannula and several doses of the drug may be administered as the trial progresses. The subject may need to fast during this time so as not to distort the results indicated by the blood samples. Additional checks, such as blood pressure, pulse, ECG and temperature, may also be carried out depending on the trial. This can take anywhere between a few hours and several days depending on the trial and may require the subject to stay on our dedicated ward for this period.

Some trials are conducted on an outpatient basis, where examinations are carried out without the subject needing to stay overnight on the ward.

Phases of clinical trials

Treating diseases more effectively requires developing new drugs and improving therapy using existing active substances, among other things. As well as investigations carried out in the laboratory or on animal models, testing on humans is ultimately crucial. This is done in so-called clinical trials. Put another way, therefore, a clinical trial means the scientific testing of drugs or medical devices on patients or other healthy subjects on a voluntary basis. This is the only way to prove whether the drug or medical device is safe and has a positive effect.

Before any new active ingredients, new combinations of active ingredients or new potential applications for known active ingredients can be approved by the authorities and adopted in practice, they must go through several phases of clinical trials on humans, and trial participants play an important role in this process.

The first time humans are subjected to such tests is known as a first-in-human (FIH) trial. This takes place in Phase I and involves a small number (10–50) of healthy, usually younger participants or, in exceptional cases, selected patients (e.g. for AIDS or cancer drugs). It is used to assess safety, tolerability and any side effects, to determine how the substance is absorbed, distributed and excreted, and to make initial estimates of what constitutes an effective dose.

In Phase II, the product being trialed is used for the first time in (a hundred to several hundred) patients, with investigations focusing on the therapeutic efficacy and the size of the dose to be administered as well as any side effects.

Once the first two phases have been successfully completed, the new drug is given to a larger number of patients (several hundred to several thousand) in Phase III in its final dosage and route of administration (e.g. as a tablet, lozenge or infusion). The aim is to prove or confirm a therapeutic benefit. To this end, the new drug is usually compared against other treatments that are already available, or a placebo (a “dummy drug”) is used as a comparator.

To be approved by the authorities (the Federal Institute for Drugs and Medical Devices (BfArM), the Paul Ehrlich Institute (PEI) or the EMA, which is the European regulatory authority), the efficacy and tolerability of the drug must be proven based on the overall study results. Only then will the drug be made available to all relevant patients outside of a trial environment.

Following approval, Phase IV trials are conducted to determine whether the long-term tolerability and quality of life offered by the new drug as well as its interactions and rare side effects continue to justify its day-to-day use when administered to a large number of patients.