Why studies are so important for patients and how to properly inform yourself.
Clinical studies are important in demonstrating the effectiveness and safety of medical treatments. At the same time, most studies are an attractive additional offer for patients. So why you should consider participating in a study, we try to discuss with the following article. To do this, we have used and answered the most frequently asked questions about studies.
For information on participating in a gynecological study at the Charité, please visit us on our study portal:
What is a study anyway?
A study is a scientific investigation that must be carried out before a drug or therapeutic concept can be approved or become routine clinical practice.
A study has to prove that a drug or a therapy concept is effective and safe for the patient and has advantages over other drugs or concepts. Clinical studies are therefore absolutely necessary in order to achieve progress in cancer treatment and to be able to develop the best and most effective therapy strategies for patients.
How is a study created?
Before a study can begin, strict scientific and legal requirements must be met. The study protocol, in which the most important features of the study are described and defined, is drawn up by various »experts« in the respective field using the latest scientific data, then assessed by an independent ethics committee and finally submitted to the state authority for approval. In order to conduct a study, patient insurance must also be taken out in the event that damage occurs that can be traced back to the study therapy.
What are the benefits of participating in a study?
Patients who take part in clinical studies receive “special care”. You will receive the latest therapy concepts, the verification and application of which are only possible within the scope of the scientific study. As early as 2000, the Austrian working group led by oncologist M. Gnant was able to prove in a study that patients with breast cancer who are treated under study conditions live significantly longer than patients who do not take part in studies. One of the reasons for this is the even more intensive care and monitoring of patients in clinical studies. Studies are therefore a quality feature of the treating clinic or practice.
Please ask about the possibility of participating in an innovative study so that you have more therapy options and can participate in the necessary improvement in the success rates of cancer therapy for ovarian, fallopian tube and peritoneum cancer.
The German study group AGO (Working Group for Gynecological Oncology) was also able to clearly show in various analyzes that study participation is a quality feature of a clinic or practice and that the connection to a study center alone can offer a survival advantage.
The therapy of cancer of the ovaries, fallopian tubes and peritoneum should preferably be carried out in the context of clinical studies in order to improve the data situation for the patients and to give them early access to the latest innovative cancer therapies.
What are my rights and obligations in the context of a study?
There are clearly defined rights and obligations associated with participating in a scientific study. If a patient falls ill or injures herself as a result of participating in a clinical examination, adequate treatment will be provided (in accordance with the provisions of the applicable Medicines Act). In accordance with the statutory provisions, patients are additionally insured against possible health disorders caused by the therapy during the clinical trial.
However, in order to maintain the insurance cover it is necessary:
- to start other medical treatment during the duration of the examination only with the consent of the investigator (of course, this does not apply to emergencies; in this case, however, the investigator must be informed).
- to take all appropriate measures to clarify the cause and scope as well as to reduce the damage
- to instruct the treating physicians, health or social insurers, at the request of the patient insurer, to prepare reports on the damage to health and also to authorize them to provide information
How will my personal data be handled?
Data and information from your medical records, which provide information about the course of the disease and certain test results, are recorded and evaluated anonymously as part of the scientific investigation. You are assured in writing that all persons and organizations involved will treat the information received with the utmost confidentiality. You will not be identifiable as a person in any report of this clinical examination.
The data processing is carried out strictly in accordance with the statutory provisions of data protection. All participants have the right at any time to find out about the type and extent of the data transmitted from their doctors.
What questions should I ask my attending physician about a clinical trial?
Regardless of this, scientific studies represent the best therapy option for patients, as they not only receive a special quality of therapy and are under special observation, but also make an important contribution to other women and to science so that the therapy can be further optimized.
Participation in clinical studies is strongly recommended as it is a basic requirement for further therapy optimization.
Important questions are:
- Who is in charge of the clinical study? Who is my contact person?
- What is the aim of the present study?
- What other centers are participating in this study?
- When did the study start, when does it end?
- Which substances will I get in the study?
- How effective are the substances? What is their side effect profile?
- What additional examinations — outside of the routine — are carried out as part of this study?
- Am I allowed to continue taking my previous medication during this study?
- What rights and obligations do I have if I take part in this investigation?
- Will my family doctor be informed about this study?
For example, ask about studies by the German study groups AGO (Working Group for Gynecological Oncology) and NOGGO (North-East German Society for Gynecological Oncology).