Clinical research
Testing before implementation
Clinical trials are an important stage in the testing and launch of medicines, including vaccines, for mass use.
Regulation and safety of research
According to the Law of Ukraine “On Medicinal Products”, a clinical trial is a research work, the purpose of which is any study involving a human subject designed to identify or confirm clinical, pharmacokinetic, pharmacodynamic and other effects, including distribution, absorption, metabolism and excretion of the medicinal product(s), detection of adverse reactions, in order to assess safety and efficacy.
It is important to note that one of the goals of the state policy to promote clinical trials is to ensure the quality, safety and efficacy of medicines, including the creation and implementation of the latest technologies to ensure patient access to innovative treatments.
Final stages of research
Phase III trials involve studying the safety and efficacy of the drug, and based on the data obtained, a decision is made on its registration and entry into pharmacy sales.
In the fourth phase, a study is conducted to monitor adverse reactions in accordance with the pharmacovigilance system, improve dosage regimens, use among different age groups, etc.
Ethics Commission
An Ethics Committee (EC) has been established at theIVMEDMedical Center, which includes leading medical specialists from theIVMEDClinic, as well as specialists from other clinical institutions, as well as biologists and scientists, lawyers, public representatives, etc., who oversee the observance of the rights, safety, well-being of the patients under study (healthy volunteers), ethical and moral principles of clinical trials.
Thus, clinical trials of medicines are conducted by our doctors only after a mandatory assessment of the ethical and moral and legal aspects of the clinical trial program by the Ethics Committee.
Regulatory framework for research
The basic document on the implementation of ethical aspects of clinical trials is the Declaration of Helsinki, developed in 1964 by the World Medical Association, and its latest (10th) revision in 2024. Based on this declaration, countries develop their own regulatory documents.
In Ukraine, clinical trials are regulated by
- Order of the Ministry of Healthcare of Ukraine No. 690 “On Approval of the Procedure for Conducting Clinical Trials of Medicinal Products and Examination of Clinical Trial Materials” dated September 23, 2009,
- Model Regulation “On Ethics Committees at Medical and Preventive Care Institutions Conducting Clinical Trials” of September 23, 2009, No. 690,
- as amended by Order No. 523 of the Ministry of Health of Ukraine dated 12.07.2012, the Law of Ukraine “On Medicinal Products” of 2022, and in accordance with the requirements of Directive 2001/20/EC of the European Parliament and of the Council of the EU,
- ICH (International Conference on Harmonization for Registration of Pharmaceuticals) GCP.
Conditions for patient engagement
A prerequisite for conducting trials is obtaining written consent from the patient (an adult with legal capacity) or his/her representative after receiving full information about the clinical trial.
Minors may participate in clinical trials only if the medicinal product is intended for the treatment of pediatric diseases, or to optimize the dosage (or dosing regimen) for minors, and only after completion of clinical trials in groups of adults with legal capacity, and after informing the guardianship and custody authorities at the place of permanent residence.
Restrictions related to the social status of minors are also taken into account, as well as the need to obtain an additional decision from the pediatric committee.
All specialists of the clinic "IVMED" who participate in clinical trials are certified specialists in this field and carry out research practice in accordance with the international standard of good clinical practice (GCP "Good Clinical Practice").
Advantages of IVMED
Diagnostic tests, the choice of treatment, medications, programs - everything is adapted to your individual indicators and circumstances.
