دورية أكاديمية
Possibilities of adaptive design implementation in clinical trials of next-in-class drugs
| العنوان: | Possibilities of adaptive design implementation in clinical trials of next-in-class drugs |
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| المؤلفون: | N. V. Vostokova, Yu. A. Trakhtenberg, E. A. Smolyarchuk, A. A. Svistunov |
| المصدر: | Ведомости Научного центра экспертизы средств медицинского применения, Vol 0, Iss 4, Pp 36-41 (2018) |
| بيانات النشر: | NEICON ISP LLC, 2018. |
| سنة النشر: | 2018 |
| المجموعة: | LCC:Medicine (General) |
| مصطلحات موضوعية: | 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, Medicine (General), R5-920 |
| الوصف: | 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 innovative products. The results of phase II-III clinical trials are illustrated by three investigational products of different pharmacological classes, including a DPP-4 inhibitor (Diabetes mellitus type 2), factor Xa inhibitor (VTE prevention in orthopedic surgery), and NNRTI (HIV). A two-stage «seamless» adaptive design was developed for the clinical trials. In all the three studies the non-inferiority hypothesis was tested versus the standards of care. The adaptive design in DPP-4 inhibitor study made it possible to assess the efficacy and safety of two consecutive treatment regiments (mono- and combination therapy). The optimal doses for factor Xa inhibitor and NNRTI were selected at Stage 1, and their efficacy and safety were tested at Stage 2. The non-inferiority vs. standards of care was successfully demonstrated for all investigational products. The introduction of the adaptive design resulted in the optimization of the clinical programs of the next-in-class drugs. |
| نوع الوثيقة: | article |
| وصف الملف: | electronic resource |
| اللغة: | Russian |
| تدمد: | 1991-2919 2619-1172 35258640 |
| Relation: | https://www.vedomostincesmp.ru/jour/article/view/104; https://doaj.org/toc/1991-2919; https://doaj.org/toc/2619-1172 |
| URL الوصول: | https://doaj.org/article/7b352586409f406fa3edce2a38faff25 |
| رقم الأكسشن: | edsdoj.7b352586409f406fa3edce2a38faff25 |
| قاعدة البيانات: | Directory of Open Access Journals |
Full Text Finder | تدمد: | 19912919 26191172 35258640 |
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