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Handbook of Neuroemergency Clinical Trials
 
 

Handbook of Neuroemergency Clinical Trials, 1st Edition

 
Handbook of Neuroemergency Clinical Trials, 1st Edition,Wayne Alves,Brett Skolnick,ISBN9780126480825
 
 
 

Alves   &   Skolnick   

Academic Press

9780126480825

9780080454351

360

260 X 184

Summarizes the state-of-the-practice of clinical trials in neurological emergencies.

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Key Features

* Presents new perspectives on acute neuroemergency clinical trials
* Includes insights from clinical pharmacology and industry perspectives
* Discusses historical lessons learned from early and recent trials in acute neuroscience populations

Description

During the 1990’s, scientific advances in understanding the mechanisms and pathophysiology of acute central nervous system injury were offset by a history of disappointing results from Phase III clinical trials of novel neuroprotective drugs. Numerous novel compounds were “tested,” and seemingly fell by the wayside. This book is intended to focus on novel therapies and the unique challenges their intended targets pose for the design and analysis of clinical trials. The authors explore the issues facing research in this area and the strategies that might lead to future success in this critical area of unmet medical need. It represents a compendium of information gained from over 20 years of clinical trial experience in areas of acute neurology and neurosurgery. From the knowledge of clinical assessment using standardized tools, to the intricate design of difficult hyper-acute neuroemergencies trials, the reader will benefit from the authors’ perspectives.

Readership

Researchers involved with the design of neuroemergency clinical trials, at research labs in universities, hospitals, major pharmaceutical (e.g., Astra Zeneca, GSK), biotechnology companies involved in these clinical areas.

Wayne Alves

Dr. Alves is Vice President of Clinical Operations at Evoke Pharmaceuticals, Inc. in Solana, California. He has held academic positions conducting basic clinical research in neuroemergency populations, and has served as consultant to numerous companies seeking to develop novel drugs.

Affiliations and Expertise

Valeant Pharmaceuticals Inc., Costa Mesa, CA, USA

Brett Skolnick

Dr. Skolnick is a Clinical Associate Professor of Neurosurgery at North Shore-LIJ School of Medicine in Manhasset, New York. He has a broad based experience with development responsibilities in neurology that includes Intracerebral hemorrhage, traumatic brain injury and stroke as well as more recently in the area of inflammation having worked on the development of multiple monoclonal antibodies in Psoriasis, Rheumatoid Arthritis, Crohn’s disease and Ulcerative Colitis. Dr. Skolnick has previously worked as a clinical development consultant to pharmaceutical companies with a focus on early novel drug development.

Affiliations and Expertise

Novo Nordisk Pharmaceuticals, Inc., Princeton, NJ, USA

Handbook of Neuroemergency Clinical Trials, 1st Edition

  • Foreword
  • Acknowledgments
  • Introduction
  • Chapter 1: Acute Ischemic Stroke
    • Publisher Summary
    • STROKE THROMBOLYSIS
    • ANTITHROMBOTIC DRUGS
    • NEUROPROTECTIVE DRUGS IN ACUTE ISCHEMIC STROKE
    • STUMBLING FROM THE BENCH TO BEDSIDE
    • FUTURE STROKE TRIALS: THE STROKE THERAPY ACADEMIC INDUSTRY ROUNDTABLE
    • CONCLUSIONS
  • Chapter 2: Subarachnoid Hemorrhage
    • Publisher Summary
    • ETIOLOGY, EPIDEMIOLOGY, AND NATURAL HISTORY
    • DIAGNOSIS, DEFINITION OF SUBPOPULATIONS, AND OUTCOMES ASSESSMENT
    • CURRENT MANAGEMENT OF ANEURYSMAL SAH
    • NOVEL, INVESTIGATIONAL, AND FAILED THERAPEUTICS
    • BIOLOGICAL MARKERS, SURROGATE ENDPOINTS, AND OUTCOMES
    • WHY DO SO MANY CLINICAL TRIALS FAIL?
    • EMERGENT CLINICAL TECHNOLOGIES AND METHODOLOGIES
    • CONCLUSION
  • Chapter 3: Spontaneous Intracerebral Hemorrhage
    • Publisher Summary
    • WHY ACUTE ICH CLINICAL TRIALS ARE DIFFICULT
    • ANIMAL MODELS: RELEVANT ISSUES FOR CLINICAL DEVELOPMENT PROGRAMS
    • EPIDEMIOLOGY AND NATURAL HISTORY
    • DIAGNOSIS AND SUBPOPULATIONS
    • CURRENT DISEASE MANAGEMENT
    • ISSUES IN CLINICAL PROTOCOL DEVELOPMENT
    • OUTCOMES
    • EFFICACY EVALUATION
    • GOLD STANDARD MEASURES
    • SURROGATE ENDPOINTS
    • SAFETY EVALUATION
  • Chapter 4: Traumatic Brain Injury
    • Publisher Summary
    • HISTORICAL CONTEXT OF TRAUMATIC BRAIN INJURY CLINICAL TRIALS
    • DRUG DEVELOPMENT PROGRAMS FOR TRAUMATIC BRAIN INJURY
    • TRAUMATIC BRAIN INJURY DRUGS AND TREATMENTS
    • EARLY CLINICAL TRIALS OF DRUGS AND BIOLOGICS FOR TRAUMATIC BRAIN INJURY
    • WHY HAVE TRAUMATIC BRAIN INJURY CLINICAL TRIALS PROVED DIFFICULT?
    • CURRENT ENVIRONMENT OF TRAUMATIC BRAIN INJURY DRUG DEVELOPMENT
    • KEY ISSUES IN TRAUMATIC BRAIN INJURY CLINICAL TRIALS DESIGN AND ANALYSIS
    • IMPROVED CLASSIFICATIONS OF TRAUMATIC BRAIN INJURY POPULATIONS
    • DAMAGE AND OUTCOME MEASURES
    • SHAPE OF OUTCOME DISTRIBUTION
    • PHARMACOKINETIC—PHARMACODYNAMIC CORRELATIONS
    • CENSORING TREATMENT POPULATIONS
    • CONCLUSION
  • Chapter 5: Acute Seizures and Status Epilepticus
    • Publisher Summary
    • DEFINITIONS
    • ANIMAL MODELS: RELEVANT ISSUES FOR CLINICAL DEVELOPMENT PROGRAMS
    • EPIDEMIOLOGY AND NATURAL HISTORY
    • MECHANISMS OF DISEASE AND PATHOLOGY
    • DIAGNOSIS AND SUBPOPULATIONS
    • CURRENT DISEASE MANAGEMENT AND CONTROVERSIES
    • ISSUES IN CLINICAL PROTOCOL DEVELOPMENT
    • OUTCOME MEASURES
    • SURROGATE ENDPOINTS
    • SAFETY EVALUATION
    • CONCLUSION
  • Chapter 6: Clinical Trials in Neuro-Ophthalmology
    • Publisher Summary
    • OPTIC NEURITIS TREATMENT TRIAL
    • ISCHEMIC OPTIC NEUROPATHY DECOMPRESSION TRIAL
    • Outcomes of IONDT
    • Results of Clinical Severity Measures
  • Chapter 7: Brain Resuscitation
    • Publisher Summary
    • EPIDEMIOLOGY AND NATURAL HISTORY
    • DIAGNOSIS AND SUBPOPULATIONS
    • CURRENT DISEASE MANAGEMENT
    • ISSUES OF CLINICAL THERAPEUTIC PROTOCOL DEVELOPMENT
    • OUTCOMES OF RESUSCITATION
    • GOLD AND SILVER STANDARDS
    • CONCLUSION
  • Chapter 8: Clinical Trials in Brain Injury After Cardiac Arrest
    • Publisher Summary
    • EPIDEMIOLOGY
    • RESEARCH AND PRACTICE INITIATIVES
    • PATHOPHYSIOLOGY
    • SECONDARY BRAIN INJURIES AFTER CARDIAC ARREST
    • FUTURE DIRECTIONS
    • CLINICAL EDUCATION AND TRIAL NETWORKS
  • Chapter 9: Efficient Dose-Response Finding Strategies for Acute Neuroemergency Treatments
    • Publisher Summary
    • BACKGROUND: THE ASTIN STUDY
    • GENERALIZED ADAPTIVE DOSE ALLOCATION TOOL
    • EFFICACY AND FUTILITY
    • SIMULATING A STROKE TRIAL
    • WHAT WE NEED TO BE ABLE TO SIMULATE
    • WHAT WE LEARN FROM SIMULATING
    • THE PROBLEMS OF SIMULATING
    • ADAPTIVE ALLOCATION
    • WHAT NEXT?
    • ACKNOWLEDGMENT
  • Chapter 10: Biostatistical Issues in Neuroemergency Clinical Trials
    • Publisher Summary
    • INHERENT HETEROGENEITY OF NEUROEMERGENCY POPULATIONS
    • CLINICAL TESTING OF NOVEL DRUGS AND TREATMENTS
    • DIAGNOSIS AND SUBPOPULATIONS
    • DOSING AND TIMING CONSIDERATIONS
    • KEY DESIGN FEATURES OF NEUROEMERGENCY TRIALS
    • HANDLING MULTIPLICITY OF ENDPOINTS
    • PRECISION OF OUTCOME MEASURES
    • VARIATION IN PROGNOSTIC FACTORS
    • WIN-NO WIN RULES
    • STATISTICAL PLANNING CONSIDERATIONS
    • SELECTION BIAS
    • MINIMIZING POTENTIAL SOURCES OF BIAS
    • APPROACHES TO RANDOMIZATION
    • HANDLING INCOMPLETE DATA
    • SEQUENTIAL ANALYSIS AND STOPPING RULES
    • DATA ANALYSIS CONSIDERATIONS
    • UNRESOLVED BIOSTATISTICAL ISSUES
    • CONCENTRATION-OUTCOME RELATIONSHIPS
    • SURROGATE ENDPOINTS
    • ADAPTIVE TRIAL DESIGNS
    • ARE LARGE PRAGMATIC TRIALS NECESSARY?
  • Chapter 11: Data Safety and Monitoring Board: Role in Acute Neurological Trials
    • Publisher Summary
    • BACKGROUND ON DATA SAFETY MONITORING BOARDS
    • DSMBs IN NEUROEMERGENCIES
    • DSMB CHARTER
    • INTERACTIONS
  • Chapter 12: Role of a Project Medical Officer in Acute Neuroemergency Clinical Trials
    • Publisher Summary
    • PMO QUALIFICATIONS
    • ASSESSMENT OF STUDY FEASIBILITY
    • STUDY DESIGN AND IMPLEMENTATION
    • REVIEW OF CRF AND CRF GUIDELINES
    • PROVIDING MEDICAL INPUT TO REGULATORY/ETHICS AND IRBS
    • THERAPEUTIC TRAINING FOR SPONSOR’S STAFF
    • SITE SELECTION
    • MEDICAL SUPPORT AT INVESTIGATOR’S MEETING
    • MANAGING EMERGING SITE ISSUES DURING ENROLLMENT
    • MANAGING SITE INITIATION PROCESS AND BOOSTER ACTIVITIES
    • GUIDING SAE AND CRF COMPLETION ISSUES
    • CODING OF MEDICAL EVENTS FOR AES AND SAES
    • WRITING/CONTRIBUTING TO THE CLINICAL TRIAL REPORT
    • SUPPLEMENTING SPONSOR’S STAFF AT REGULATORY MEETINGS
    • SUMMARY
  • Chapter 13: Ethical Considerations in Neuroemergency Clinical Trials
    • Publisher Summary
    • THE CONCEPT OF RISK
    • THE CONCEPT OF BENEFIT
    • STUDY DESIGN CONSIDERATIONS
    • EVALUATION OF A THERAPEUTIC HYPOTHESIS
    • USE OF PLACEBO CONTROL SUBJECTS
    • STATUTORY BASIS OF CURRENT CLINICAL TRIALS REGULATIONS
    • GENERAL ROLE OF THE INSTITUTIONAL REVIEW BOARD
    • OVERVIEW OF HUMAN SUBJECTS PROTECTION REGULATIONS
    • INFORMED CONSENT PROCEDURES
    • WAIVER OF CONSENT
    • EMERGENCY RESEARCH CONSENT WAIVER
    • RESEARCH INVOLVING CHILDREN
    • OTHER CONSENT MECHANISMS
    • DEFERRED CONSENT
    • IRB KNOWLEDGE OF LOCAL CONDITIONS
    • FINANCIAL COMPENSATION ISSUES
    • IMPORTANT RESOURCES FOR RESEARCH ETHICS TRAINING
  • Chapter 14: Industry Perspective on Drug Development
    • Publisher Summary
    • SELECTION OF PHARMACOLOGICAL TARGETS AND NECROSIS VERSUS APOPTOSIS
    • ANIMAL MODELS
    • CONTROLLED CONDITIONS OF THE ANIMAL EXPERIMENT VERSUS CLINICAL CHAOS
    • TIME WINDOW, GLUCOSE, TEMPERATURE, AND BRAIN COMPOSITION
    • UNMET MEDICAL NEEDS AND DRUG DEVELOPMENT
    • RISKS TO NEUROTHERAPEUTIC DRUG DEVELOPERS
    • ECONOMICS OF CNS DRUG DEVELOPMENT
    • FACTORS INFLUENCING ECONOMIC FEASIBILITY IN CNS DRUG DEVELOPMENT
    • COSTS OF DEVELOPMENT
    • INDUSTRIAL INVESTMENT AND PRODUCTIVITY
    • DECREASED RESEARCH PRODUCTIVITY
  • Chapter 15: Regulatory Perspective
    • Publisher Summary
    • INVESTIGATIONAL NEW DRUG APPLICATIONS
    • COMMUNICATING WITH THE FDA
    • ROLE OF THE CORE DATA SHEET
    • FAST TRACK DEVELOPMENT PROGRAMS
    • ACCELERATED APPROVAL
    • SUBPART E PROGRAMS
    • PRIORITY REVIEW
    • WAIVER OF PROSPECTIVE INFORMED CONSENT
    • ORPHAN PRODUCT DESIGNATION
    • IMAGING PROTOCOLS
    • HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT PRIVACY REGULATIONS
    • LICENSE APPLICATION PROCESS
    • POSTAPPROVAL ISSUES: MARKETING, PATIENT REGISTRIES, ADVERTISING, AND PROMOTIONAL MATERIALS
    • CONCLUSION
  • Index
 
 
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