What is a clinical study?

A clinical trial is usually a carefully planned, global project, the purpose of which is to test new, previously unused methods of diagnosis or treatment, which in glass or animal studies seem to have a high chance of being highly effective. Clinical studies include the testing of drugs, diagnostic procedures, surgical procedures, and medical equipment.

Without conducting a clinical trial, it is not possible to introduce any medicine, medical equipment, or diagnostic method to the market. Also, innovative methods of performing surgical procedures require objective confirmation of effectiveness in a large group of patients. Only well-planned and phased clinical studies with the participation of people allow for the continuous development of medicine and the improvement of diagnostic and treatment techniques.
Participation in clinical studies

Participation in clinical studies

A clinical study can last from several weeks to several years. All visits to the center, appointments with the physician, diagnostic tests, and drug administration are planned in detail in terms of course and frequency. Depending on the type of medicine and examination, visits and administration of medicines may take place every 1, 2, 4, or 8 weeks. During participation in a clinical trial, the patient's health and well-being are always put first, and any change in well-being and test results are carefully monitored by the entire study team.

A patient who wants to take part in the study should first read the study information form in detail, including the study plan, diagnostic procedures, and visit schedule. This is an essential element before deciding to start the treatment because signing the consent to participate in the study means the need to appear at the Center for all visits indicated in the consent and to observe the medical recommendations.

Before the administration of drugs, as part of a clinical trial begins, it is necessary to carefully confirm that it does not pose a threat to the patient's health and life and that the intensity of the symptoms of the disease is high enough to confirm its efficacy. Therefore, it is necessary to first take a thorough medical history, perform blood tests and other diagnostic tests, and regularly keep a diary of the symptoms of the disease.

Patients taking part in the trial of new drugs can tell the physician or study staff at any time that they no longer want to participate in a clinical trial, without having to give any specific reason. Making such a decision by the patient does not affect in any way the quality of basic medical care he has received so far from his treating physician. This only involves the discontinuation of treatment as part of a clinical trial and the cessation of the obligation to report to the facility within the predefined deadlines.

Medical visits, diagnostic tests, and treatment as part of a clinical study are completely free of charge for the participating patients. In most clinical studies, it is also possible to apply for reimbursement of travel costs to the facility where the trial is conducted.

Our clinical studies and biological agents

At the Melita Medical Center, we try to treat our patients in accordance with the latest available knowledge and technology, also using the developing methods of treatment.

Hence, our patients can count on treatment under clinical studies with the latest drugs, even before they are marketed, but already at the stage where the safety profile is known. We also conduct numerous studies in which the efficacy of biological drugs approved for the treatment of other autoimmune diseases is compared (e.g. guselkumab), or drugs of the same ‘family’ as those already approved for treating patients with the given clinical entity are investigated (e.g. brepocitinib and ritlecitinib versus tofacitinib). The biological treatment programs at our facility are designed for patients suffering from ulcerative colitis, Crohn's disease, eosinophilic esophagitis, and non-alcoholic steatohepatitis.

As part of clinical studies, we also treat patients with reflux esophagitis, but not using biological agents.

Our clinical studies and biological agents