HISTORICAL ANALYSIS OF GOOD CLINICAL PRACTICE DEVELOPMENT AND ESTABLISHMENT
DOI:
https://doi.org/10.11603/2312-0967.2022.3.13340Keywords:
Good clinical practice, clinical trials, medicines, historical analysis, ethical principlesAbstract
The aim of the work. To determine the historical aspect of Good Clinical Practice (GCP) key stages of development and establishment.
Materials and Methods. In the research the results of the analysis of scientific and special literature of historical development and strengthening of requirements for clinical trials, as well as such research methods as historical, systematic, analytic-comparative, logical analysis and generalization were used.
Results and Discussion. Based on the study of the historical chronology of GCP development, five stages of this process have been identified: I. VI cent. BC – XI cent. – attention to the maintenance of ethical principles in the relationship between the doctor and patient, use of control group in a food experiment, and the emergence of first rules for drug testing; II. XVI cent. – XIX cent. – first experiments with humans’ participation, which are the basis for the modern approaches to clinical research; III. beginning of XX cent. – 40s of the XX cent. – gradual formation and strengthening of the requirements for pharmaceuticals, food products and cosmetics, regarding labeling, compounds, safety and informational support; IV. 40s of the XX cent. – 80s of the XX cent. – numerous attempts to regulate the requirements of clinical trials (Nuremberg Code, Universal Declaration of Human Rights, International Covenant on Civil and Political Rights, International Covenant on Economic, Social and Cultural Rights, Declaration of Helsinki and others); V. 80s of the XX cent. – today – adoption by WHO and the Council of International Organizations of Medical Sciences the single international document on the conduction of biomedical research involving humans. Implementation of the GCP Guidelines in 1997 with subsequent amendments and editions.
Conclusions. The analysis of GCP requirements development, shows that the elevant historical events and their consequences led to the understanding of the need to control and regulate the process of clinical trials. The GCP guidelines are based on the key provisions of the Declaration of Helsinki and the Nuremberg Code, thus the GCP requirements fully protect the health and safety of the subjects, participating in clinical trials.
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