What is a clinical trial?
CTO (Clinical Trials Office) coordinates applied clinical research. This is a form of scientific research that aims to improve the efficacy of current standard treatments, improve tolerability of existing therapies, or learn more about the mechanisms of a particular disease or identify and diagnose diseases more accurately.
Phases of clinical research
Once laboratory tests and animal experiments have yielded positive results, clinical trials are being considered and eventually implemented. Clinical trials usually consist of four distinct phases which are being completed consecutively. If serious deficiencies/side-effects occur during a phase, research plans can be modified or stopped definitively.
In phase 1, we investigate how a small group of patients tolerates and responds to a new treatment. We seek answers to questions such as "how should the new treatment be administered, how often and what is a safe dosage or treatment schedule?". Phase 1 research is mainly conducted on healthy volunteers. In oncology, however, only patients are eligible.
In the second phase, we want to find out whether a new treatment or new combination of treatments is effective for a particular type of disease. The effectiveness of the treatment is key, along with its safety. In this phase in oncology, we usually focus on a well-defined type of cancer.
In a phase 3 clinical study, a standard treatment is compared with a new treatment or a new combination of treatments, typically in a large group of patients. If the new treatment has satisfying results and if it is safe, an application for registration of the product/treatment is submitted based on all the phase 1, 2 and 3 studies.
When the previous studies have produced satisfying results, the treatment is officially registered. Doctors may now start prescribing the treatment. Phase 4 trials then look at long-term side effects or the effects in combination with other medications or treatments.
Safety
- Each clinical study must be conducted in accordance with the legislation and, if applicable, submitted to the relevant authorities, including the Federal Agency for Medicines and Health Products (FAMHP).
- An independent Medical Ethics Committee evaluates the study protocol to protect the general well-being, safety, dignity, rights and privacy of patients. Only when both the government and the Medical Ethics Committee have reported no shortcomings, may a study start.
- The investigators (doctors and staff) work in accordance with the ICH-GCP guidelines and existing legislation and adhere to the guidelines imposed by the study protocol.
- Both the doctors-specialists of the Oncology Centre and the CTO unit have an on-call system so you can reach a CTO staff member 24 hours a day. Moreover, you can call on the hospital's emergency service at any time.
- The doctors closely monitor each study patient and record all reactions. Moreover, there is an exchange of information between the different study sites and a continuous follow-up and communication with the sponsor of the study product.
Participate in oncology research
You can ask your doctor
Are you a patient and would you like to participate in a scientific study? There may be a clinical study that is of interest to you. You can ask your doctor.
Even if you are not yet receiving treatment at the oncology centre, and you have heard about a study being conducted at the GZA Hospitals through the media, you can discuss with your doctor whether you might be interested in participating in that study. You can also make the first contact with the Oncology Centre yourself for consultation.
Your doctor may ask you to participate in a medical scientific study. You will then receive information, both verbally and in writing. You do not have to decide immediately whether you want to participate or not. The choice is always yours. You should never feel any obligation to participate in any type of clinical study. This decision has no consequences for your further treatment.
The choice: participate or not
Participation is always and explicitly voluntary. Even once the research has started, you can always interrupt your participation for whatever reason. You have no obligations whatsoever. This decision has no consequences for your future treatment.
Before you make your decision, it is important to know and understand as much as possible about the study. It is the task of your care provider and the CTO staff to provide you with sufficient information. They will discuss with you the study product, the aim and course of the study, the benefits, possible side effects, etc.
Financial
Taking part in a clinical trial does not necessarily mean that your treatment will be free or more financially beneficial. You may be asked to pay for treatments and tests that you would also receive if you did not participate in the study (standard care). Treatments and tests specific for the study which would not have been performed if you did not participate in the study will be reimbursed by the sponsor of the study. Before the start of the study, we will discuss at length with you which examinations you will or will not have to pay for and which will be reimbursed by the sponsor of the study.
Privacy?
You will not be mentioned by name in the information collected during the study. This means that your direct identification data, such as your name and date of birth, will not be disclosed within the framework of the study. Your identity will be replaced by an identification code. The study doctor will store this identification code carefully. Every person accessing your data during the clinical trial is bound by professional secrecy or the obligation of confidentiality. Your identity will also remain confidential when the results are published.
Consent
If you decide to participate in the study, you will be asked to sign an informed consent form. This confirms that you have received the necessary information, that you understand this information and that you wish to participate of your own free will. Your doctor will also sign the form. Informed consent is not a binding contract, however. You are free to decide at any time to no longer take part. If you do so, be sure to inform your doctor.
The information leaflet provides more general information. It explains the purpose of the clinical trial, how the trial is conducted, what the advantages and disadvantages of taking part are, what happens to your data, etc. Do not hesitate to ask any additional questions you may have if you are unclear about certain matters.