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During the research projects conducted by KO-MED, the patient's safety is the most important. Special procedures and constant health monitoring serve this purpose.
About clinical trials

Clinical trials are large-scale research projects aimed at introducing new drugs to the pharmaceutical market. They provide patients with access to innovative pharmaceuticals, which are a chance to cure various diseases. At the same time, they allow pharmaceutical companies to verify whether and how the healing process works using the tested product. Therefore, clinical trials allow the assessment of the effects, absorption, distribution and metabolism of a pharmaceutical product, first and foremost in the consideration of the patient’s well-being and safety.

Over the centuries, the development of medicine has contributed to the fact  that today people can reasonably expect to live much longer than their ancestors. Many previously incurable illnesses can nowadays be successfully treated with a properly selected drug. Our immunity has significantly improved, because dozens of  diseases are prevented thanks to widespread vaccination. Each of these pharmaceutical products which play such an important  part in prolonging average life expectancy has passed through the stage of clinical trials. They were all tested and improved before they could become available to patients. In the past, however, this process of testing and trials did not take place in such a strictly regulated way and according to such high safety standards. Today’s clinical trials methodology means that introducing pharmaceuticals to the market takes place with mutual benefits for the patient and for science.

Clinical trials are divided into stages, thanks to which patients receive pharmaceuticals thoroughly verified in terms of safety. It is assumed that only 1 out of 10,000 discovered molecules with therapeutic effects will eventually go on the market. It usually takes 10-15 years to monitor their therapeutic effects.

Phases of clinical trials
The individual phases of clinical trials are under strict control of scientists and physicians. In addition, the entire clinical trial project must comply with legal standards (linked to the Patient Rights and Responsibilities), which have been defined in the European Union and in Poland.
Basic trials
Conducted in the laboratory
Pre-clinical trials
Without the involvement of human organisms
Phases of clinical trials 0-IV
With the participation of human organisms
Basic trials
Conducted in the laboratory
Pre-clinical trials
Without the involvement of human organisms
Phase 0
With the participation of 10-15 healthy volunteers in specialized centres
Phase I
With the participation of 80-100 healthy volunteers in specialized centres
Phase II
With the participation of 50–300 patient volunteers in specialized centres
Phase III
With the participation of several hundred - several thousand patients in specialized centres
Phase IV
With the participation of several hundred patients in specialized centres
Objective
Determination of the safety of effect
Objective
Understanding the mechanism of action
Objective
Determination of the safety of effect on a healthy human organism
Objective
Determination of dosage and adverse reactions
Objective
Confirmation of efficacy and safety of treatment in ailing patients
Objective
Preparation of medical documentation indispensable for the introduction of the medicine
Objective
Determination of long-term action of the medicine and estimation of therapy costs