Regulatory and Legal Regulation of the Organization and Conduct of Clinical Trials at the International Level to Guarantee Patient Safety

Clinical trials (CT) at the international level with human participation are necessarily subject to clear and comprehensive international ethical standards in approved documents that have been in force since 1964, in order to protect the human right to health and their safety. Since then, numerous regulatory documents in the field of CT have been developed in the world, which are based on the study of previous experience in compliance, primarily with patient safety rules, and are also constantly updated to include regulatory and organizational technologies in response to the challenges of the time or requests of society. The regulatory and legal documents on the conduct of clinical trials, which are given in the review article, are directive documents for many countries, even if a country did not participate in their development, in particular for Ukraine. The participation of the World Health Organization (WHO) is highlighted in many methodological materials for the possibility of implementing directives in WHO member countries, which indicates its leading position in public health research and interest in safety control for a person participating in clinical trials and patients. WHO combines partnerships of state bodies with intergovernmental bodies and non-governmental organizations providing medical care, foundations, clinical trials sponsors, research centers and pharmaceutical companies to achieve an effective result, as well as prevent violations of ethical norms, since research is related to health and can potentially bring participants not only benefit, but also harm. The article also highlights currently unsettled issues regarding current regulatory and legal acts that do not provide detailed formalization, and the solution of many problems of clinical trials remains at the discretion of the developer. International experience in regulating clinical trials shows that none of the regulatory systems is absolutely perfect, so it is necessary to constantly monitor its effectiveness and update it. Today, information on clinical trials is available only to the Regulatory Authorities of the European Union, the European Commission and national regulatory authorities, and leading clinical trial sponsor companies publish information about their studies only on their own websites, and there is no single pan-European information resource on clinical trials. It was found that the latest approach to global clinical trial regulation works in favor of leading transnational corporations by spreading patent law, which limits the right to conduct clinical trials by medium-sized and small pharmaceutical companies. The analysis of regulatory documents on the organization and conduct of clinical trials at the international level showed that the documents need to be improved and updated taking into account the challenges of the time regarding the spread of major human diseases.