What is clinical research?
Clinical research includes all scientific studies that are performed in humans, with the aim of increasing our biological or medical knowledge.
The goal of clinical research is to benefit patients by constantly increasing our knowledge.
Clinical research involves patient volunteers who have received clear, correct, and complete information about the study.
There are three types of studies:
- Interventional studies (category 1) involve an intervention in an individual that is not justified by his or her normal care. These studies primarily investigate new medications, but also other types of interventions such as surgical procedures or medical devices.
- Interventional studies with minimal risks and constraints (category 2) can include minimally invasive interventions or procedures from a decreed list. They may also involve studies of healthcare products under normal use conditions.
- Noninterventional studies (category 3) do not alter patient care, all procedures and products are in regular use, and there are no extra or unusual diagnostic, treatment, or monitoring procedures. These are observational studies.
How can I participate in a clinical study?
If you are eligible for an ongoing study at our facility (evaluation of a medication, technique, or device or disease monitoring) your doctor is likely to offer you the chance to participate in it after having explained the objectives of the study.
How do I agree to participate?
Your doctor or one of his or her collaborators will explain to you in detail the scientific objectives of the study, as well as how your participation will contribute to medical progress. During this consultation, you will be given an information sheet. This document will present the study objective, the products (or techniques) studied, and the expected risks/benefits. After giving you adequate time to reflect and answering all of your questions, your freely given, written, informed consent or decision to not opt out will be collected.
Will I be treated differently than other patients?
Whether or not you decide to participate in the study, the medical care that you receive will come from the same department and be delivered by the same medical staff. If you participate in a clinical trial, you will receive specific monitoring, particularly to evaluate the tolerance and efficacy of the treatment or technique that is being studied.
If it appears that your participation in the study is no longer in your best interests, the doctor can withdraw you from the study at any time.
Do I have to participate in the study after I have signed the consent form?
You are free to withdraw your consent and leave the study at any time. This will have no effect on your medical care.