Handbook of Neuroemergency Clinical Trials, Second Edition, focuses on the practice of clinical trials in acute neuroscience populations, or what have been called neuroemergencies. Neuroemergencies are complex, life-threatening diseases and disorders, often with devastating consequences, including death or disability. The overall costs are staggering in terms of annual incidence and costs associated with treatment and survival, yet despite their significance as public health issues, there are few drugs and devices available for definitive treatment. The book focuses on novel therapies and the unique challenges their intended targets pose for the design and analysis of clinical trials.
This volume provides neurologists, neuroscientists, and drug developers with a more complete understanding of the scientific and medical issues of relevance in designing and initiating clinical development plans for novel drugs intended for acute neuroscience populations. The editors provide the best understanding of the pitfalls associated with acute CNS drug development and the best information on how to approach and solve issues that have plagued drug development.
1. Introduction - p. xv 2. Part I. Acute Ischemic Stroke - p. xix 3. Chapter 1. Acute Ischemic Stroke - p. 3 4. Chapter 2. Subarachnoid Hemorrhage - p. 23 5. Chapter 3. Clinical Trials in Spontaneous Intracerebral Hemorrhage - p. 47 6. Chapter 4. Imaging Biomarkers in Stroke Trials - p. 65 7. Part II. Traumatic Brain Injury - p. 82 8. Chapter 5. Traumatic Brain Injury - p. 85 9. Chapter 6. Improving Approaches to Evaluate Efficacy and Safety of Drugs for Traumatic Brain Injury - p. 111 10. Chapter 7. Brain Imaging in Traumatic Brain Injury - p. 127 11. Chapter 8. The Use of Blood-Based Biomarkers to Improve the Design of Clinical Trials of Traumatic Brain Injury - p. 139 12. Introduction - p. 139 13. Summary of Search of Clinical Trials in Traumatic Brain Injury Using Biomarkers - p. 142 14. Surrogate Endpoints and Selection of Central Nervous System–Specific Protein Biomarkers for Severe Traumatic Brain Injury Diagnostics - p. 148 15. Discussion - p. 154 16. Prospects and Pathways for Incorporation of Blood-Based Biomarkers Into the Design of Clinical Trials for Traumatic Brain Injury - p. 156 17. Chapter 9. Biostatistical Issues in TBI Clinical Trials - p. 167 18. Part III. Seizure Emergencies - p. 185 19. Chapter 10. Acute Seizures and Status Epilepticus - p. 189 20. Overview - p. 189 21. Diagnosis and Definition of Status Epilepticus - p. 189 22. Classification of Status Epilepticus - p. 190 23. Animal Models: Relevant Issues for Clinical Development Programs - p. 192 24. Epidemiology and Natural History - p. 195 25. Mechanisms of Disease and Pathology - p. 200 26. Diagnosis and Subpopulations - p. 201 27. Current Disease Management and Controversies - p. 205 28. Issues in Clinical Protocol Development - p. 211 29. Outcome Measures - p. 217 30. Surrogate Endpoints - p. 220 31. Safety Evaluation - p. 221 32. New Trials and Potential Challenges - p. 222 33. Conclusion - p. 222 34. Chapter 11. Posttraumatic Seizures - p. 231 35. Part IV. Nontraumatic Neuroemergencies - p. 243 36. Chapter 12. Neuroemergencies in Critical Care Patients - p. 247 37. Chapter 13. Neuroemergency Clinical Trials: Migraine - p. 267 38. Chapter 14. Acute Visual Deficits - p. 281 39. Part V. Devices for Neuroemergencies - p. 302 40. Chapter 15. Implications for New Trials in Acute Ischemic Stroke in the New Era of Endovascular Therapy - p. 305 41. Part VI. Key Issues in Neuroemergency Clinical Trials - p. 313 42. Chapter 16. The Role of a Project Medical Officer in Acute Neuroemergency Clinical Studies - p. 317 43. Chapter 17. Regulatory Considerations - p. 329 44. Chapter 18. Military Perspectives on Brain Injuries: Implications on Clinical Trials - p. 361 45. Index - p. 369
Handbook of Neuroemergency Clinical Trials, Second Edition, focuses on the practice of clinical trials in acute neuroscience populations, or what have been called neuroemergencies. Neuroemergencies are complex, life-threatening diseases and disorders, often with devastating consequences, including death or disability. The overall costs are staggering in terms of annual incidence and costs associated with treatment and survival, yet despite their significance as public health issues, there are few drugs and devices available for definitive treatment. The book focuses on novel therapies and the unique challenges their intended targets pose for the design and analysis of clinical trials.
This volume provides neurologists, neuroscientists, and drug developers with a more complete understanding of the scientific and medical issues of relevance in designing and initiating clinical development plans for novel drugs intended for acute neuroscience populations. The editors provide the best understanding of the pitfalls associated with acute CNS drug development and the best information on how to approach and solve issues that have plagued drug development.
1. Introduction - p. xv 2. Part I. Acute Ischemic Stroke - p. xix 3. Chapter 1. Acute Ischemic Stroke - p. 3 4. Chapter 2. Subarachnoid Hemorrhage - p. 23 5. Chapter 3. Clinical Trials in Spontaneous Intracerebral Hemorrhage - p. 47 6. Chapter 4. Imaging Biomarkers in Stroke Trials - p. 65 7. Part II. Traumatic Brain Injury - p. 82 8. Chapter 5. Traumatic Brain Injury - p. 85 9. Chapter 6. Improving Approaches to Evaluate Efficacy and Safety of Drugs for Traumatic Brain Injury - p. 111 10. Chapter 7. Brain Imaging in Traumatic Brain Injury - p. 127 11. Chapter 8. The Use of Blood-Based Biomarkers to Improve the Design of Clinical Trials of Traumatic Brain Injury - p. 139 12. Introduction - p. 139 13. Summary of Search of Clinical Trials in Traumatic Brain Injury Using Biomarkers - p. 142 14. Surrogate Endpoints and Selection of Central Nervous System–Specific Protein Biomarkers for Severe Traumatic Brain Injury Diagnostics - p. 148 15. Discussion - p. 154 16. Prospects and Pathways for Incorporation of Blood-Based Biomarkers Into the Design of Clinical Trials for Traumatic Brain Injury - p. 156 17. Chapter 9. Biostatistical Issues in TBI Clinical Trials - p. 167 18. Part III. Seizure Emergencies - p. 185 19. Chapter 10. Acute Seizures and Status Epilepticus - p. 189 20. Overview - p. 189 21. Diagnosis and Definition of Status Epilepticus - p. 189 22. Classification of Status Epilepticus - p. 190 23. Animal Models: Relevant Issues for Clinical Development Programs - p. 192 24. Epidemiology and Natural History - p. 195 25. Mechanisms of Disease and Pathology - p. 200 26. Diagnosis and Subpopulations - p. 201 27. Current Disease Management and Controversies - p. 205 28. Issues in Clinical Protocol Development - p. 211 29. Outcome Measures - p. 217 30. Surrogate Endpoints - p. 220 31. Safety Evaluation - p. 221 32. New Trials and Potential Challenges - p. 222 33. Conclusion - p. 222 34. Chapter 11. Posttraumatic Seizures - p. 231 35. Part IV. Nontraumatic Neuroemergencies - p. 243 36. Chapter 12. Neuroemergencies in Critical Care Patients - p. 247 37. Chapter 13. Neuroemergency Clinical Trials: Migraine - p. 267 38. Chapter 14. Acute Visual Deficits - p. 281 39. Part V. Devices for Neuroemergencies - p. 302 40. Chapter 15. Implications for New Trials in Acute Ischemic Stroke in the New Era of Endovascular Therapy - p. 305 41. Part VI. Key Issues in Neuroemergency Clinical Trials - p. 313 42. Chapter 16. The Role of a Project Medical Officer in Acute Neuroemergency Clinical Studies - p. 317 43. Chapter 17. Regulatory Considerations - p. 329 44. Chapter 18. Military Perspectives on Brain Injuries: Implications on Clinical Trials - p. 361 45. Index - p. 369
