Frequently Asked Questions about Clinical Trials
What to know before participating in a study
What is a clinical trial?
First things first
- The testing of a new drug takes place in four consecutive stages (study phases). The Federal Institute for Drugs and Medical Devices provides an overview.
- Participation in a clinical trial offers opportunities, but also carries risks. Participants must be informed about both beforehand.
- Patients participating in a study must meet requirements defined for each study (both inclusion and exclusion criteria).
Key questions before study participation
- What is the objective or 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 a random assignment?
- What arguments suggest that this new approach could be beneficial? Are there preliminary studies?
- What are my potential benefits from participating in a study?
- What are the possible risks for me when participating in a study?
- What additional burdens will I face when participating in a study, compared to usual treatment?
- Will I incur costs by participating in the study, such as travel expenses to the study site?
- Will my health insurance cover the treatment costs within the study?
- What obligations do I undertake if I participate in the study?
- What happens if I want to discontinue the therapy in the study?
- What treatment alternatives are there in my situation?
- Who funds the study?
What do I need to consider when participating in a study?
Benefits of Study Participation
- even more intensive care and monitoring
- generally, treatment according to the latest therapy concepts
- important contribution for other women and science. Because the more comprehensive the data, the greater the significance and knowledge gained from the study, and the subsequent optimizations of the therapy.
Reasons against study participation
Rights and Obligations of Study Participation
Rights
According to legal provisions, patients are insured during clinical trials against possible health disorders caused by the therapy. This includes adequate treatment of health disorders.
Obligations (to maintain insurance coverage)
Other medical treatments may only be performed with the consent of the principal 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 be commissioned by the patient’s insurer, upon request, to prepare reports on the health damage 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 the disease and certain examination results. These are recorded in pseudonymized form as part of the scientific investigation and evaluated in compliance with strict data protection laws.
Can I withdraw from the study?
You can withdraw from study participation at any time, as study participation 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 discontinue the study.
It is important to consider what exactly you wish to withdraw. Do you only want to end the therapy? Do you want to end the entire data collection? Because even after the therapy has ended, valuable information is still collected in the so-called follow-up, which can provide statements on the efficacy and safety of the therapy or other research questions.
How are scientific studies conducted?
Phase I Studies: generally serve to test a drug on healthy volunteers for dosage, tolerability, and side effects. For cancer drugs, in this phase, the drug is tested on a very small patient cohort and under controlled conditions.
Phase II Studies: test the efficacy and tolerability of a new therapy on slightly larger patient cohorts. Here, the therapy concept is first reviewed and the appropriate dose is found.
Phase III Studies: re-evaluate the efficacy and tolerability of the active substance in an expanded patient cohort. They also investigate whether the new treatment is equivalent, superior, or inferior to standard therapy (or a placebo treatment).
Phase IV Studies: are large studies conducted after a drug’s approval to test and optimize care standards.
What defines 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 strong involvement in current studies. You can search for certified cancer centers in your area at www.oncomap.de. For modern clinics, engagement in research and science is now a quality and distinguishing feature. This guarantees patients optimal therapy and internationally reinforces Germany’s reputation as a leading clinic location. Speak to your treating physician about current studies. Additionally, you can find current studies on breast cancer here.
The approval process for a drug or therapy concept in Germany is as follows:
Detailed scientific investigation:
- Efficacy of the drug
- the advantages over standard therapies
- Safety (including side effects)
Approval and procedure of a scientific investigation:
- Random allocation of study participants into two groups
- Group 1 (so-called experimental group) receives the drug to be tested
- Group 2 (so-called control group) is treated with the established standard for this disease (for diseases for which there is currently no standard treatment, 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 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 can be guaranteed to patients.
