Абрамович Михаил Львович (RU),Плоскирева Антонина Александровна (RU)
申请号：
RU2014139162
公开号：
RU2014139162A
申请日:
2014.09.29
申请国别(地区):
RU
年份:
2016
代理人:
摘要：
A method of evaluating the efficacy and safety of therapy in clinical trials, including the evaluation of the obtained clinical or clinical laboratory values, expressed in numeric format, with respect to the reference values and the calculation of the relative frequency of deviations from the reference values for the patient group over time (e.g., up to beginning study therapy, during the therapy, after the treatment course completion), characterized in that assesses the reliability difference relative frequencies show deviations teley before therapy and at follow-up visit (during or after therapy) so that if in the control (during or after therapy) visit significantly lower relative frequency deviation indicators patients from the reference values in the group compared with the original data, it is It says about the effectiveness and safety of applied therapy, and if follow-up visit was significantly higher relative frequency deviations of parameters of patients from the reference values in the group compared to the initial visit, it svidete lstvuet the ineffectiveness of applied therapy (disease progression, complications) or adverse reactions to the study drug, and if at the control visit significant differences in relative frequency deviation indicators patients from the reference values compared with the original data has been received, it is regarded as no effect of active clinical or clinical and laboratory data of the studied drug.Способ оценки эффективности и безопасности терапии при проведении клинических исследований, включающий в себя оценку полученных клинических или клинико-лабораторных показателей, выраженных в числовом формате, по отношению к референсным значениям и расчет относительных частот отклонений от референсных значений для группы пациентов в динамике (например, до начала изучаемой терапии, в процессе терапии, после завершения курса лечения), отличающийся тем, что проводится оценка достоверности разности относительных частот отклоне
