FOR PATIENTS

FOR PATIENTS

A rich collection of information that every patient should be familiar with.

INTERNATIONAL PROGRAM

While planning a clinical trial a so-called sponsor, or a pharmaceutical company; the manufacturer of the future drug defines the goals of the study and the way it is implemented by constructing the so-called – study protocol, also prepares an accurate description of the test substance, take the results of all the performed preclinical and clinical studies, which it contains in the so-called Investigator’s brochure. These documents are subject to evaluation specifically for this designated organization – FDA / Food and Drug Administration / in the United States and / or established by the European Parliament EMEA / European Medicines Evaluation /. After obtaining its approval, the sponsor himself or through one of the companies set up for this purpose organizes a network of clinical trial centers that will carry out this study. Such a network must consist centers in many different countries in order to check the effect of the substance in various climatic and nutritional conditions, etc.

During the organization of a clinical trial in Poland, the organizing company must obtain the approval of the Bioethics Committee taking into account the well-being and safety of participants in clinical trials and the Central Register of Clinical Trials.

The Bioethics Committee supervises the study throughout its duration, gathers information about serious side effects (SAEs) that occurred during its course.

The sponsor collects data on the current state of health of study participants on an ongoing basis from all centers. These data, after an statistical processing indicate whether the tested substance was more effective and safe than the drug with which it was compared.

At the end of this process, the sponsor announces the results of research. Sends to the centers a data “deblocking” the test, i.e. information, which substances used in the study were accepted by every participant in the study.

CONTACT FORM FOR PATIENTS



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