Clinical Trials in the Neurosciences

A properly designed and executed clinical trial that addresses an import question and delivers a definitive result can
change the practice of medicine worldwide. This book encompasses a bench-to-bedside approach and serves as an excellent
guidance for translating preclinical studies to early phase I/II and phase III trials. In the first part, the book
covers preclinical science with respect to animal models of various neurological diseases, FDA requirements for
preclinical studies, translation of animal to patient studies and scaling up from animal to human studies. In the
second part, the design of phase I/II trials and the use of biomarkers as surrogate endpoints are discussed. With
regard to phase III trials, FDA and European requirements, specific design issues, relevant clinical endpoints as well
as data management and quality are examined. Topics specific to multicenter trials, such as design, recruitment of
special populations, monitoring, ethical and consent issues are also covered. Finally, genetics, gene therapy, imaging
and surgical devices are reviewed.

This publication is highly recommended to clinician researchers, such as neurologists, neurosurgeons, pediatric
neurologists and neonatologists, who want to design and conduct clinical trials in the neuroscience, but also to
nurses, research coordinators and clinical pharmacologists.