Abstract
The most important role of the assessment of undesirable events of drugs takes a special significance in clinical trials when it is important to specify, identify and comprehensively assess the indirect influence of drugs because such information will be the basis for the further stages of clinical trials, as well as future directions of pharmacovigilance. According to the Ukrainian rules of conducting the clinical trial (order #690 from 23 Sept., 2009) adverse reactions (ARs) are considered as those that at least have a causal relationship between medicinal product administrations. At the same time determination of adverse event (AE) is not so definite because sometimes there may be abnormalities, which may appear without drug administration. The analysis of documentation of 17 clinical trials has been performed in order to determine the definitions of AE/AR regarding assessment, registration and control of undesirable manifestations while conducting the clinical trial of new drugs and bioequivalence studies of drugs. As a result of this analysis the discrepancies in the synchronization of information concerning the understanding and assessment of AE/AR among all participants of clinical trials and bioequivalence studies have been found. The corresponding algorithms of the abnormality assessment have been developed by the study investigator with the purpose of the accurate data entry into the case report forms and source documents. These algorithms help to conduct the comprehensive analysis of AE/AR, minimize the number of mistakes during data entry and make the standards of the data entry process, data capture and AE/AR assessment in accordance with international requirements. The implementation of such algorithms in the system of work of the site unit will improve the work of the monitor, as well as the investigator who is responsible for data capture, monitoring and data entry while conducting the clinical trial.
Highlights
The most important role of the assessment of undesirable events of drugs takes a special significance in clinical trials when it is important to specify, identify and comprehensively assess the indirect influence of drugs because such information will be the basis for the further stages of clinical trials, as well as future directions of pharmacovigilance
According to the Ukrainian rules of conducting the clinical trial adverse reactions (ARs) are considered as those that at least have a causal relationship between medicinal product administrations
At the same time determination of adverse event (AE) is not so definite because sometimes there may be abnormalities, which may appear without drug administration
Summary
The most important role of the assessment of undesirable events of drugs takes a special significance in clinical trials when it is important to specify, identify and comprehensively assess the indirect influence of drugs because such information will be the basis for the further stages of clinical trials, as well as future directions of pharmacovigilance. The corresponding algorithms of the abnormality assessment have been developed by the study investigator with the purpose of the accurate data entry into the case report forms and source documents These algorithms help to conduct the comprehensive analysis of AE/AR, minimize the number of mistakes during data entry and make the standards of the data entry process, data capture and AE/AR assessment in accordance with international requirements. У настанові з належної клінічної практики запропоновано поняття побічної дії та побічного явища, які дозволяють відокремити негативні непередбачувані реакції від несприятливих медичних проявів під час застосування препарату [8, 9]. У процесі проведення досліджень ЛЗ на здорових добровольцях, зазвичай це І фаза КВ та дослідження біоеквівалентності, досить часто виникають ситуації, коли представник спонсора може невірно інтерпретувати поняття ПР/ПЯ, наведені в GCP, або навіть взагалі не передбачати можливості виникнення ПЯ у добровольців до моменту введення препарату [7, CLINICAL PHARMACY. Метою роботи стало створення алгоритму для оцінки дослідником/монітором відхилень від нормальних показників, використання якого дозволить проводити своєчасний моніторинг та оцінку небажаних явищ (ПР/ПЯ), що виникають у пацієнтів/добровольців у будь-який момент клінічного випробування
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