Possibilities of adaptive design implementation in clinical trial of next-in-class drugs
IPHARMA article "Possibilities of adaptive design implementation in clinical trial of netx-in-class drugs" has been published in The Bulletin of the Scientific Center for Expert Evaluation of Medicinal Products has published (4, 2016).
The article investigates the possibility of streamlining the methodology of clinical studies of next-in-class drugs by implementing an adaptive design. The results of clinical trials are illustrated by three investigational products of diffrent pharmacological classes, including a DPP-4 inhibitor (Diabetes mellitus type 2), factor Xa inhibitor (VTE prevention in orthopedic surgery), and NNTRI (HIV).
Vostokova N.V., Executive Director, PharmD Trakhtenberg J.A., Medical Director, MD, PhD
I. M. Sechenov First Moscow State Medical University Smolyarchuk E.A., Associate professor of the Department of Clinical Pharmacology and Internal Medicine Propaedeutics, PhD Svistunov A.A., First Vice-Rector—Vice-Rector for Innovation Policy and International Activities, MD, professor