Possibilities of adaptive design implementation in clinical trials of next-in-class drugs

Possibilities of adaptive design implementation in clinical trials of next-in-class drugs

The article investigates the possibility of streamlining the methodology of clinical studies of next-in-class drugs by implementing an adaptive design. Next-in-class drugs are original drugs with known biological targets, similar in structure and mode of action to already existing well-established i...

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Bibliographic Details
Main Authors: N. V. Vostokova, Yu. A. Trakhtenberg, E. A. Smolyarchuk, A. A. Svistunov
Format: Article
Language:Russian
Published: Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) 2018-02-01
Series:Регуляторные исследования и экспертиза лекарственных средств
Subjects:
адаптивный дизайн
лекарственные препараты
препараты «next-in-class»
гипотеза неуступающей эффективности (non-inferiority)
клинические исследования ii-iii фазы
adaptive design
drugs
next-in-class drugs
non-inferiority hypothesis
phase ii-iii clinical trials
Online Access:https://www.vedomostincesmp.ru/jour/article/view/104

Internet

https://www.vedomostincesmp.ru/jour/article/view/104

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