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Study Participation
Many patients want to actively support cancer research and may also have unfinished business with the disease. Studies offer a good opportunity to do so, as they are the only way to improve treatment methods.
What is behind a clinical trial or participation in a study? A clinical trial is a planned scientific research project in which new treatment options, drugs, therapeutic procedures, or diagnostic tests are investigated. The aim is to improve cancer treatment, develop new therapeutic options, and increase the quality of life of patients. Studies are an important component of medical research: without the participation of patients, new therapies could not be tested or further developed.
To ensure that the results of clinical trials can make a valuable contribution to new treatment options for future generations of patients, clinical trials must follow strict rules. They are supervised by specially trained physicians, scientists, and research teams. Each study is supervised by an investigator. This person is responsible for the overall management of the study and bears all responsibilities, especially in studies with multiple trial centers or participating sites. Each study has a precisely defined goal and a clear procedure: it is precisely specified who can participate, how the treatment is carried out, and which safety checks are planned at which times.
All studies are subject to ethical review before they begin and must be approved by the Federal Institute for Drugs and Medical Devices (BfArM). This also ensures that our study participants are protected as best as possible.
Why should you participate in a study?
Before a new drug or procedure is tested on patients, it undergoes extensive testing to ensure its basic safety. Only the study can show whether a new therapy is equivalent or superior to established procedures. For example, side effects may not yet be fully known.
It is important that studies are only conducted in accredited clinics or research centers with experienced staff and in compliance with strict national and international guidelines (Good Clinical Practice, or GCP for short).
In this context, the trial phase is also crucial: early studies involve more uncertainties, while late studies build on previous research and provide a clearer picture of efficacy and risks.
Participating in a study can have advantages, e.g.:
- Access to new therapies that are not otherwise available
- Intensive medical care during the study
- Opportunity to contribute to research to help future patients
But there are also risks, e.g.:
- Unknown side effects may occur
- The therapy may not work better than standard therapy
It is crucial to make an informed decision before potentially participating in a study.
Talk to your treating physician to find out whether participating in a study might be an option for you. Participation in a study is always voluntary, without exception, and can be discontinued at any time without affecting the actual treatment.
What types of studies and study phases are there?
Clinical studies can differ in terms of the type of therapy and the study phase. They serve to test the safety, efficacy, and potential risks of new treatment methods.
Types of studies
- Therapy studies:
These studies examine how well new drugs, combinations of therapies, or treatment methods work and how well they are tolerated. The aim is to further improve the treatment of cancer.
- Diagnostic studies:
These studies investigate new methods for the early detection, diagnosis, or monitoring of cancer—for example, new imaging techniques or blood tests.
- Therapy-accompanying and follow-up studies:
These studies address issues related to quality of life, mental health, nutrition, exercise, or the long-term effects of cancer treatment—in other words, how patients can be best supported during and after therapy.
- Registry or observational studies:
These studies collect data from patients without changing their treatment. The aim is to better understand how cancer progresses in practice and which factors influence the course of the disease.
Not all studies are “clinical” in the strict sense. Epidemiological studies, for example, observe large population groups without applying new therapies. A distinction is made here between interventional and non-interventional studies.
Interventional studies actively intervene in the treatment of patients to test the efficacy, safety, or tolerability of a new therapy, drug, or treatment method. In non-interventional studies, on the other hand, no new treatment is applied, with the aim of collecting data on progression, side effects, or quality of life without changing medical care.
Clinical Cancer Registry
In addition to researching the incidence and risk factors for cancer, the University Cancer Center Hamburg (UCC Hamburg) has set itself the goal of ensuring the existing quality of oncological care. An important tool for this is the Clinical Cancer Registry of the UCC Hamburg. It collects information on the quality of treatment, which can be used to develop and review measures for quality improvement.
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Study phases:
- Phase I – Initial studies in humans
In oncology, drugs are tested exclusively on people with cancer. The aim of this phase is to find out how a new drug behaves in the body, what dosage is effective, and how well it is tolerated. New therapies, radiation techniques, surgical procedures, and medical devices are also tested in this phase.
- Phase II – Efficacy and initial results
In phase II, the study is extended to more patients for the first time, as initial safety data is already available. The focus here is on the efficacy of the therapy. How is the new drug distributed in the body, how is it excreted, what concentrations occur in tumor tissue, blood, cerebrospinal fluid, and urine, and how does the body metabolize the drug? At the same time, the type, duration, and frequency of side effects continue to be closely monitored in order to develop the safest possible treatment concept.
- Phase III – Large-scale efficacy studies
Phase III involves a large number of patients because the therapy has already been thoroughly investigated. The aim of these studies is to comprehensively test the efficacy and risks. The results of this phase are decisive in determining whether a therapy can be approved and used as standard treatment. Above all, there must be a clear advantage over standard therapy.
- Phase IV – Application studies after approval
Phase IV examines whether an already approved drug is suitable for new clinical pictures. The results are reviewed by the drug regulatory authority and can be included in the package insert so that future patients can safely benefit from the new application.
New diagnostic procedures are only used in medical practice once their reliability has been proven in studies. Medical devices such as CT scanners, radiation equipment, and surgical lasers are also tested in clinical trials for performance and safety.
Who conducts studies and who pays for them?
Clinical studies are financed in different ways. Some studies are supported by companies—for example, pharmaceutical companies that manufacture new drugs. Other studies are funded by independent funding organizations, the Federal Ministry of Education and Research (BMBF), research communities, or private foundations such as German Cancer Aid.
The following distinctions are made:
- Industry or pharmaceutical studies:
These are usually financed and organized by pharmaceutical companies. They often involve the development and approval of new drugs. - Non-commercial studies (IITs – Investigator Initiated Trials):
These studies are initiated by doctors or scientific institutions themselves – i.e., not by the pharmaceutical industry. They often examine practical issues, such as how existing therapies can be better combined or side effects reduced.
Clinical trials are conducted at various institutions, such as university hospitals, research facilities, private practices, or pharmaceutical companies. The same legal and ethical requirements apply to all study initiators and locations.
What does Good Clinical Practice (GCP) mean?
Good Clinical Practice refers to internationally recognized ethical and scientific quality standards for the planning, conduct, documentation, and reporting of clinical trials involving human subjects. The aim of GCP is to ensure the protection of trial participants, the security of data, and the scientific reliability of results.
Clinical trials are regulated by:
Clinical trials may only be conducted in facilities that meet these high quality standards.
Current Trials at UCC Hamburg
The UCC Hamburg conducts interventional clinical trials for drug development and numerous studies in the areas of mental health, lifestyle, and aftercare. The trials are managed by our trial center in collaboration with our partners in the UCC Hamburg network.
Further information:
Do you have any questions or would you like to make an appointment? Here you will find our contact details for UCC Hamburg.
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