Clinical Trials in the Neurosciences (Frontiers of Neurology and Neuroscience)

"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."--BOOK JACKET Cover......Page 1 1 Title Page.pdf......Page 2 1 Title Page......Page 14 2 Introduction......Page 26 3 Evolution of Clinical Trials in Neurology......Page 29 4 Role of Animal Studies in the Design of Clinical Trials......Page 34 5 Translating Interventions from Ischemic Stroke Models to Patients The View in 2009......Page 59 6 Scaling Up from Animal to Human Studies......Page 64 7 FDA Requirements for Preclinical Studies......Page 71 8 Phase I-II - Design and Analysis......Page 75 9 Biomarkers in Neurology......Page 79 10 FDA Investigational New Drug Requirements......Page 86 11 European Union Regulatory Requirements......Page 90 12 Adaptive Clinical Trials......Page 95 13 Design and Analysis Plans......Page 100 14 Behavioral-Neuropsychological Outcomes and Quality of Life Endpoints......Page 102 15 Clinical Endpoints......Page 117 16 Data Management and Quality Assurance......Page 122 17 Multidisciplinary Trial Design......Page 130 18 Design and Analysis Issues......Page 138 19 Strategies for Recruiting and Retaining Minorities......Page 142 20 Informed Consent and HIPAA......Page 145 21 Committees for Multicenter Clinical Trials......Page 148 22 Interim Monitoring of Clinical Trials......Page 151 23 Medical Monitoring......Page 155 24 Budgets for Clinical Trials......Page 157 25 Institutional Review Boards and Ethical Issues in Randomized Clinical Trials......Page 160 26 Financial Conflict of Interest......Page 165 27 Clinical Trials in Progressive Neurological Diseases......Page 168 28 Genetics in Clinical Trials......Page 176 29 Randomized Clinical Trials in Children......Page 182 30 Neurological Emergencies......Page 187 31 Neurological Emergencies......Page 198 32 Gene Therapy Clinical Trials in the Human Brain......Page 204 33 Magnetic Resonance Imaging for Surrogate Outcomes and Patient Selection......Page 213 34 Computed Tomography......Page 217 35 Positron Emission Tomography Imaging......Page 221 36 Clinical Research Training Opportunities and Elements......Page 227 37 Appendix......Page 230 38 Author Index......Page 232 39 Subject Index......Page 233