Frequently asked questions about clinical trials
What you should know before taking part in a trial
What is a clinical trial?
Important things first
- Testing a new medicine takes place in four consecutive stages (trial phases). The Federal Institute for Drugs and Medical Devices provides an overview.
- Taking part in a clinical trial offers opportunities, but also involves risks. Trial participants must be informed about both in advance.
- Patients who take part in a trial must meet requirements defined for each trial (both inclusion and exclusion criteria).
Important questions before taking part in a trial
- What is the aim or research question of the trial?
- What is the trial design, i.e. the methodological structure of the trial?
- Can I choose the type of treatment freely, or is there a random allocation?
- What arguments suggest that this new approach could be beneficial? Are there preliminary studies?
- What potential benefits might I gain from taking part in the trial?
- What potential risks do I face by taking part in the trial?
- What additional burdens will I face by taking part in the trial compared with standard treatment?
- Will I incur any costs as a result of taking part in the trial, such as travel costs to the trial site?
- Will my health insurance cover the treatment costs within the trial?
- What obligations do I take on if I participate in the trial?
- What happens if I want to stop the therapy in the trial?
- What treatment alternatives are available in my situation?
- Who funds the trial?
What do I need to consider when taking part in a trial?
Benefits of taking part in a trial
- even more intensive care and monitoring
- as a rule, treatment according to the latest therapy concepts
- an important contribution for other women and for science. The more extensive the data available, the greater the informative value and insights gained from the trial and the subsequent optimisation of therapy.
Reasons against taking part in a trial
Rights and obligations when taking part in a trial
Rights
In accordance with legal provisions, patients are insured during the clinical trial against possible health impairments caused by the therapy. This includes appropriate treatment of the health impairments.
Obligations (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 health damage, all appropriate measures must be taken to clarify the cause and extent and to mitigate the damage. Treating physicians, health or social insurers may, at the request of the patient insurer, be commissioned to prepare reports on the health damage and also be authorised to provide information.
What happens to my personal data?
Personal data and information from your medical records provide information about the course of the disease and about certain examination results. These are recorded in pseudonymised form as part of the scientific study and analysed in compliance with strict data protection laws.
Can I withdraw my participation in the trial?
You can withdraw your participation in the trial at any time, as participation in a trial is a voluntary and individual decision and remains so even after consent has been given. You do not have to fear any disadvantages in treatment if you discontinue the trial.
How do scientific studies work?
Phase I trials: as a rule, these are used to test a new therapy in healthy volunteers for dosage, tolerability and side effects.
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 determined.
Phase III trials: again assess efficacy and tolerability of the active substance in an expanded patient cohort. They also examine whether the new treatment is equivalent, superior or inferior to standard therapy (or treatment with a placebo).
Phase IV trials: are large studies conducted after a medicine has been approved to review and optimise real-world care.
What defines a trial centre?
The care and treatment of cancer patients should always be carried out in centres certified for this purpose. Certified cancer centres are characterised, among other things, by strong involvement in current trials. At www.oncomap.de you can search for certified cancer centres in your area. For modern clinics, engagement in research and science is now a hallmark of quality and a distinguishing feature. This guarantees patients optimal therapy and strengthens Germany’s reputation as a clinical location internationally. Ask your treating doctor about current trials. In addition, you can find current trials on ovarian, fallopian tube and peritoneal cancer here.
Path to approval in Germany
In Germany, the path to approval of a medicine or therapy concept is as follows:
Comprehensive scientific study:
- Efficacy of the medicine
- the advantages over standard therapies
- Safety (including side effects)
Approval and conduct of a scientific study:
- Random allocation of trial participants into two groups
- Group 1 (the so-called experimental group) receives the medicine being tested
- Group 2 (the so-called control group) is treated with the standard established for this disease (for diseases for which there is no standard treatment yet, the comparison is against a so-called placebo, i.e. a treatment without an active substance).
- Trials must meet strict scientific, legal and ethical requirements in order to be approved.
- Clinical trials must be conducted according to internationally defined quality criteria (ICH-GCP, International Conference on Harmonisation-Good Clinical Practice). In this way, reliable data can be generated and the greatest possible benefit for patients can be guaranteed.
