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Clinical research. The path of a drug from history to pharmacologic research

DOI: https://doi.org/10.29296/25879979-2023-07-07

E.S. Zhuravleva
Separate Medical Division «CoMed» LLC «Ligand Research», Moscow, [email protected]

In the article we will touch upon the history of the emergence of clinical trials of medicines and the need for these trials, we will analyze why evidence-based medicine is needed. Let’s look into the history of clinical trials, in what years and how the drug trials were conducted, on what animals. We will learn how science evolved to prove the detrimental effects of drugs widely used in a certain period of time, as well as the discovery of insulin therapy as a factor that reduces the risk of death. Clinical scientific research with human participants is necessary, it is conducted to assess the efficacy and safety of a new medicinal product or to expand the indications for the use of an already known medicinal product. The procedure of registration of a new medicinal product is carried out by the state in order to determine the quality of the new medicine, its benefits and possible risks of use. Let us consider in detail the scheme of registration of medicinal products. All clinical trials of medicinal products for medical use are conducted in one or several medical organizations in accordance with the rules of good clinical practice, in accordance with the fundamental ethical principles of the Declaration of Helsinki and other normative documents regulating the protection of rights, safety and health of the tested (volunteer) patient over the interests of science and society. There are 4 phases of clinical trials, which will be discussed in detail in the article.

clinical trials
patient safety.

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