How is a clinical trial organized?

Where do clinical trials take place?
Clinical trials take place in all kinds of hospitals and clinics, but mostly in academic hospitals. They are organized by researchers and doctors.

Where does the money come from?
The money to organize clinical trials comes from different sources, usually pharmaceutical companies, public funds from either university or national or international institutes or private funds from non-profit organizations.

What is the typical development of a clinical trial?
Usually, doctors propose their patients to participate in a clinical trial either right after the diagnosis or later during the treatment. Patients can also tell their doctors that they want to participate in clinical trials or can search for information on clinical trials that are recruiting patients.

Before participation, 2 major things have to be done:
1- Each clinical trial has its own criteria and all criteria must be respected, otherwise the participation in the clinical trial is not possible. Your doctor will have a checklist and will verify if all points can be ticked for you. Sometimes, this requires additional biological or radiological examinations.
2- You will have to give your informed consent before participating. Informed consent means that you agree to participate and have been informed of the goal of the clinical trial, its risks and your rights. Your doctor will explain this to you and will give you written information. Once you agreed to participate in the clinical trial, your doctor will ask you to sign an informed consent form. Throughout the study, you will be informed of all relevant information on the safety and efficacy of the treatment. One of your most important rights is to leave the clinical trial at any time without giving any reason and without any consequence on your treatment. You will be treated according to the established standards of care.

Once your doctor verified the checklist and you signed the informed consent form, you will enter the clinical trial.

The development of a clinical trial is based on a protocol. A protocol is a strict procedure that doctors and patients have to comply with in order to ensure the quality of the clinical trial. When you agreed to participate, you agreed to comply with this protocol. According to the protocol, you will have a list of appointments with your doctor and for radiological and biological exams. You will also have to report all effects you experienced with the treatment and sometimes you will have to fill in some questionnaires. You also may have to avoid certain type of drugs or food during the treatment. All the information will be collected into a special file and data will be saved into a secure database. All this information and your identity will be kept confidential.

The length of a clinical trial depends on its phase. The longest are phase III clinical trials where doctors will usually follow you for at least 5 years. The frequency of the appointments is often high the first year but lower afterwards, close to the frequency of the appointments for cancer patients not involved in the clinical trial.