About clinical trials

A clinical trial is every trial conducted with participation of people in order to discover or confirm clinical, pharmacological, including pharmacodynamic effects of action of one or many therapeutic products being tested, or in order to identify undesired effects of one or a larger number of examined therapeutic products, or to investigate absorption, distribution, metabolism and elimination of one or a larger number of examined therapeutic products, having in mind their safety and effectiveness; (definition under art.2 item 2 of the Pharmacy Act, Journal of Laws, Dz.U.2017 item 2211).

Clinical trials are aimed at finding new methods of treatment as well as of new drugs to combat known diseases. Every drug, wound dressing or medical procedure which is released to be used on a medical market, undergoes three phases of clinical trials.

• In Phase 1 a trial is conducted on a small number of healthy persons or sick patients in case of a drug for incurable disease. In the trial of Phase 1 the safety is verified, along with effectiveness of a drug being tested, as well as its impact on an organism. Such a trial is conducted mainly in laboratories.
• In phase 2 a clinical trial is conducted on a larger number of patients suffering from a given disease, on whom effectiveness of an examined drug for a specific disease is checked, along with the safety of a drug being tested. Also, an effective dose of the examined drug is specified by a comparison with the so-called placebo, administered as part of a trial to a group of patients. Trials of phase 2 are conducted in centers specializing in given diseases.
• Clinical trial of Phase 3 is conducted on a very large number of patients. Main objectives of a trial of this phase include: first and foremost, evaluation  of safety and effectiveness of a given drug, specification of appropriate dosage to be used in therapy, evaluation  of undesired incidents, i.e. counterindications to use of this drug in patients with a given disease or comparison of clinical trials results with standard methods of treatment.
• Trials of phase 3 last even for several years. After a completion of a trial and obtaining of a good result one can apply for registration of a new drug for a given disease.
• Clinical trial of Phase 4 constitutes the so-called trial following the registration and release of a given drug to the market. Such a trial lasts for a relatively long time and is conducted on a large number of patients in order to confirm effectiveness, safety as well as undesired incidents, for example, effects after many years of using a given substance or undesired interaction with other substances used by a patient.

Safety of conducted clinical trials in the Osteomed Medical Center:
In our Center every clinical trial is conducted pursuant to the ICH-GCP guidelines (Principles of Good Clinical Practice developed by International Conference of Harmonization of Good Clinical Practice).