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Менеджмент / Management

Несоблюдение режима приема изучаемого препарата как причина недостоверных результатов клинического исследования / Non-adherence as the reason for unreliable results of a clinical study

DOI: http://dx.doi.org/10.21518/1561-5936-2019-4-46-50

О.Г. Мелихов, к.м.н., А.О. Татаренко, Институт клинических исследований, Москва

В статье рассматриваются причины несоблюдения пациентами режима приема изучаемого препарата (non-compliance) в ходе клинического исследования и способы оценки соблюдения графика лечения. Определяется влияние данного нарушения протокола на результаты исследований и стоимость разработки препаратов. Приводится математическое обоснование необходимости увеличения размера выборки с учетом возможных отклонений от протокола. 

O.G. Melikhov, Cand. of Sci. (Med.), A.O. Tatarenko, Institute of Clinical Trials, Moscow

The article describes sources of drug non-compliance in clinical trials and methods of assessment of compliance. Protocol violations in terms on non-adherence to study treatment and their effect on study results and on costs of drug development are discussed. Sample size calculation considering possible non-compliance and protocol deviations presented.

Источники / References

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Ключевые слова: клинические исследования, соблюдение режима приема исследуемого препарата, достоверность данных, clinical studies, clinical research, clinical trials, drug compliance, study treatment adherence, quality of data, reliability of data

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