International Clinical Trials
What is a clinical trial?
A clinical trial is scientific research. It investigates whether a new drug can be approved or proven drug therapy concepts can be optimized in clinical routine. Clinical trials are used to test the efficacy and safety of new procedures or drugs. The methodological structure of a study depends on the question to be investigated.
In Germany testing of a new drug takes place in four successive stages (study phases). The Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) or Federal Institute for Drugs and Medicines provides an overview of this.
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 prerequisites that are defined for each study (both inclusion and exclusion criteria).
What can clinical trials do for me?
Clinical trials are essential to achieve progress in cancer treatment. They are also essential to develop the best and most effective treatment strategies for patients. Participation in clinical trials can be beneficial (quality attribute & prognostic factor). In your individual case, talk to your physician about current studies.
Pro:
- even more intensive support and monitoring
- treatment according to the latest therapy concepts, new chances
- important contribution for other women and science, the more comprehensive the data, the greater the significance and knowledge gained from the study and the subsequent optimization of the therapy
Contra
- inclusion and exclusion criteria defined in the study protocol, as these serve to precisely limit the group of patients involved and also as a safety measure for the patient
- certain concomitant diseases may also exclude
- depends on the individual case
Important questions before particapting in a clinical trial
- What is the aim or the research question of the study?
- What is the study design, i.e. the methodological structure of the study?
- Can I freely choose the type of treatment, or is there randomization?
- What are the arguments that this new approach could be beneficial? Are there any preliminary studies?
- What are my possible benefits from participating in this specific study?
- What are the possible risks for me in participating in a study?
- What additional burdens will I face if I participate in a study, compared to the usual treatment?
- Will I incur any costs as a result of participating in the study, such as travel costs to the study site?
- Will my health insurance cover the treatment costs within the study?
- What obligations do I have if I participate in the study?
- What happens if I want to discontinue the therapy in the study?
- What treatment alternatives are available in my situation?
- Who is financing the study?
Your physician will help you to answer these questions.
