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Abstract

ANTINEOPLASTIC DRUGS: A FOCUS ON FEATURES OF REGISTRATION, IMPROVING THE QUALITY OF CLINICAL TRIALS USING A PATIENT-CENTERED LOGISTICS APPROACH

Elena Litvinova*, Olga Posilkina, Svitlana Kovalenko and Anastasiia Lisna

ABSTRACT

The aim of the work is to analyze and summarize existing scientific approaches and mechanisms for fast-track approvals, improving the quality of antineoplastic drugs clinical trials using a patient-centered logistics approach. Materials and methods: Databases of the Internet, such as PubMed, the Food and Drug Administration, the European Medicines Agency, State Expert Center of the Ministry of Health of Ukraine were used. The retrospective, logical, and graphical methods of research, as well as the content analysis were applied. Results: One of the main problems of antineoplastic drugs authorization is often significant uncertainty about the degree of clinical benefit of new drugs when entering the market. In order to improve the quality of clinical research in the authorization of antineoplastic drugs, post-marketing studies with clinically significant endpoints and a representative composition of participants, pharmacovigilance, are of great importance. Within clinical research, endpoints should be clinically relevant, sensitive to therapy, well measurable and interpretable. A comprehensive evaluation of performance indicators allows an adequate assessment of the ratio of the expected benefit to the possible risk of using antineoplastic drugs. The introduction of a patient-centered logistics approach, including the use of modern information technologies, social networks, crowdsourcing, patient self-education, personalized medicine in clinical trials of antineoplastic drugs also contributes to improving their quality during authorization. Conclusions: The analysis of the most acceptable endpoints and the use of a patient-centered logistics approach is becoming increasingly important in clinical trials of antineoplastic drugs, contributing to an increase in the efficiency and quality of research.

Keywords: quality assurance, patient-centered logistics approach, clinical trials, antineoplastic drugs.


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