Frequently asked questions about clinical trials
Things to know before participating in a trial
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More InformationWhat is a clinical trial?
First things first
- A new drug is tested in four successive stages (study phases). The Federal Institute for Drugs and Medicines provides an overview.
- Participation in a clinical trial opens up opportunities, but also entails risks. Study participants must be informed about both in advance.
- Patients participating in a study must fulfill requirements that are defined for each study (both inclusion and exclusion criteria).
Characteristics of a clinical trial
- First application on humans
- about 10 to 30 test subjects
- in oncology, usually patients with advanced disease
Important questions before participating in a study
- What is the aim or question of the study?
- What is the study design, i.e. the methodological structure of the study?
- Can I choose the type of treatment freely, or is there a random decision?
- What arguments suggest that this new approach could be beneficial? Are there any preliminary studies?
- What are the possible advantages of participating in a study?
- What are the possible risks for me when participating in a study?
- What additional burdens will I face if I take part in the study compared to the usual treatment?
- Will I incur any costs as a result of participating in the study program, such as travel costs to the study location?
- Will my health insurance cover the treatment costs within the study?
- What obligations do I enter into if I take part in the study?
- What happens if I want to stop the therapy in the study?
- What treatment alternatives are there in my situation?
- Who is funding the study?
What do I have to consider when participating in a study?
Advantages of participating in a study
- Even more intensive support and monitoring
- Generally treatment according to the latest therapy concepts
- important contribution for other women and for science. The more comprehensive the data, the greater the informative value and knowledge gained from the study and the subsequent optimization of the therapy.
Reasons not to participate in the study
Rights and obligations when participating in a study
Rights
In accordance with the statutory provisions, patients are insured against possible health problems caused by the therapy during the clinical trial. This includes adequate treatment of the health problems.
Obligations (in order to obtain insurance cover)
Other medical treatments may only be carried out with the consent of the investigator (except in emergencies). In the event of damage to health, all appropriate measures must be taken to clarify the cause and extent of the damage and to mitigate it. At the request of the patient’s insurer, the attending physicians, health insurers or social insurers may be instructed to draw up reports on the damage to health and to authorize them to provide information.
What happens to my personal data?
Personal data and information from your medical records provide information about the course of your illness and certain examination results. This data is recorded in pseudonymized form as part of the scientific investigation and stored in compliance with the strict data protection laws.
Can I withdraw my participation in the study?
You can withdraw from the study at any time, as participation in a study is a voluntary and individual decision and remains so even after consent has been given. You do not have to fear any treatment disadvantages if you withdraw from the study.
It is important that you consider what exactly you want to revoke. Do you only want to end the therapy? Do you want to stop the entire data collection? This is because even after the therapy has ended, valuable information is still collected in the so-called follow-up, which can provide information on the effectiveness and safety of the therapy or further questions.
How do scientific studies work?
Phase I studies: are generally used to test a drug to be tested on healthy volunteers for dosage, tolerability and side effects. In the case of cancer drugs, the drug is tested in this phase on a very small group of patients under controlled conditions.
Phase II trials: test the efficacy and tolerability of a new therapy in somewhat larger patient cohorts. Here, the therapy concept is first reviewed and the appropriate dose is found.
Phase III trials: re-examine the efficacy and tolerability of the active substance in an expanded patient population. They also investigate whether the new treatment is equivalent, superior or inferior to standard therapy (or treatment with a placebo).
Phase IV studies: are large studies after approval of a drug to test and optimize the standard of care.
What makes a study center?
The care and treatment of cancer patients should always be carried out in certified centers. Certified cancer centers are characterized, among other things, by their strong involvement in current studies.
You can search for certified cancer centers in your area at www.oncomap.de. For modern clinics today, commitment to research and science is a quality and distinguishing feature. This guarantees patients the best possible treatment and is a convincing argument internationally for Germany as a hospital location.
Talk to your doctor about current studies. You can also find current studies on ovarian, fallopian tube and peritoneal cancer here.
Approval procedures in Germany
The approval process for a medicinal product or therapy concept in Germany is as follows:
Detailed scientific investigation:
- Efficacy of the medicinal product
- the advantages over standard therapies
- Safety (e.g. side effects)
Approval and procedure of a scientific investigation:
- Random allocation of study participants to two groups
- Group 1 (so-called test group) receives the drug to be tested
- Group 2 (so-called comparison group) is treated with the standard established for this disease (for diseases for which there is no standard treatment to date, the comparison is made against a so-called placebo, i.e. a treatment without active substance).
- Studies must meet strict scientific, legal and ethical requirements in order to be approved.
- Clinical trials must be conducted in accordance with internationally defined quality criteria (ICH-GCP, International Conference on Harmonization-Good Clinical Practice). In this way, reliable data can be compiled and patients can be guaranteed the greatest possible benefit.
