These are programs of research on already used or new drugs, which are carried out in order to confirm their effectiveness, extend therapeutic indications and safety of use. Around the world, hundreds of thousands of patients each year participate in such studies. Approval for their conduct is issued by appropriate institutions: the independent Bioethics Committee, the Minister of Health, additionally the test is registered in the Central Register of Clinical Trials. These institutions constantly monitor clinical trials, ensuring their proper course.
The research is carried out by the Chief Researcher / Principal Investigator – a specialist doctor with the highest professional qualifications and experience in diagnosing and treating patients. Before treatment, each patient is informed in detail about the course of the study (medications taken, diagnostic tests performed, frequency of follow-up visits, duration of individual visits and the entire study, etc.) and gives their informed consent to participate in the clinical trial.
The introduction of innovative methods of treatment over several years has resulted in significant progress in the prevention and therapy of diseases that are an age-old problem in medicine. A patient participating in a clinical trial does not bear any costs of treatment and diagnostics provided by the clinical trial protocol. There is a possibility of reimbursement of travel costs to the center for individual control visits.
A person suffering from a specific disease and meeting the so-called inclusion criteria that are included in the study protocol. The decision about inclusion in a clinical trial is made by the attending physician-researcher who recruits patients for the trial.
Before deciding to enter a clinical trial, the patient should obtain as much information as possible about the trial in order to be able to give free, informed consent to participate in the clinical trial.
Each test has a precisely defined so-called inclusion criteria and exclusion criteria. They tell you what conditions must be met in order to be included in the study and what factors make it impossible to take part in the study. It should be very clearly stated that according to the requirements of Good Clinical Practice (GCP), only the attending physician (researcher) is entitled to include the participant in a clinical trial, so he will make the final decision.