German 
Studies
A “collection of questions” cannot and does not want to replace the doctor-patient conversation, but rather should serve as an orientation and motivational aid. The personal conversation is and will remain the indispensable basis for a good doctor-patient relationship.
Many scientific studies have shown that “informed patients” were less afraid of the cancer and were overall more satisfied with the medical care.
Question:
What is a medical study and how is it created?
Answer:
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 harmless for the patient and has advantages over other drugs or concepts. Clinical studies are therefore imperative to make progress in cancer treatment and to develop the best and most effective therapeutic strategies for patients.
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 federal authorities 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.
Question:
What are the benefits of participating in a study?
Answer:
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 the oncologist M. Gnant (for the study: click here) was able to prove in a study that breast cancer patients 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.
Question:
What questions should I ask my attending physician about a clinical trial?
Answer:
First of all, it should be emphasized once again: 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 B. after studies of the German study groups AGO (Working Group for Gynecological Oncology) and NOGGO (North-East German Society for Gynecological Oncology).