基本説明
Represents a compendium of information gained from over 20 years of clinical trial experience in the area of acute neurology and neurosurgery.
Full 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.
Contents
ForewordAcknowledgmentsIntroductionChapter 1: Acute Ischemic Stroke Publisher SummarySTROKE THROMBOLYSISANTITHROMBOTIC DRUGSFUTURE STROKE TRIALS: THE STROKE THERAPY ACADEMIC INDUSTRY ROUNDTABLECONCLUSIONSChapter 2: Subarachnoid Hemorrhage Publisher SummaryETIOLOGY, EPIDEMIOLOGY, AND NATURAL HISTORYNOVEL, INVESTIGATIONAL, AND FAILED THERAPEUTICSBIOLOGICAL MARKERS, SURROGATE ENDPOINTS, AND OUTCOMESEMERGENT CLINICAL TECHNOLOGIES AND METHODOLOGIESCONCLUSIONChapter 3: Spontaneous Intracerebral Hemorrhage Publisher SummaryWHY ACUTE ICH CLINICAL TRIALS ARE DIFFICULTANIMAL MODELS: RELEVANT ISSUES FOR CLINICAL DEVELOPMENT PROGRAMSEPIDEMIOLOGY AND NATURAL HISTORYDIAGNOSIS AND SUBPOPULATIONSCURRENT DISEASE MANAGEMENTOUTCOMESEFFICACY EVALUATIONGOLD STANDARD MEASURESSURROGATE ENDPOINTSSAFETY EVALUATIONChapter 4: Traumatic Brain Injury Publisher SummaryDRUG DEVELOPMENT PROGRAMS FOR TRAUMATIC BRAIN INJURYTRAUMATIC BRAIN INJURY DRUGS AND TREATMENTSWHY HAVE TRAUMATIC BRAIN INJURY CLINICAL TRIALS PROVED DIFFICULT?DAMAGE AND OUTCOME MEASURESPHARMACOKINETIC-PHARMACODYNAMIC CORRELATIONSCENSORING TREATMENT POPULATIONSCONCLUSIONChapter 5: Acute Seizures and Status Epilepticus Publisher SummaryDEFINITIONSANIMAL MODELS: RELEVANT ISSUES FOR CLINICAL DEVELOPMENT PROGRAMSEPIDEMIOLOGY AND NATURAL HISTORYDIAGNOSIS AND SUBPOPULATIONSCURRENT DISEASE MANAGEMENT AND CONTROVERSIESOUTCOME MEASURESSURROGATE ENDPOINTSSAFETY EVALUATIONCONCLUSIONChapter 6: Clinical Trials in Neuro-Ophthalmology Publisher SummaryOPTIC NEURITIS TREATMENT TRIALISCHEMIC OPTIC NEUROPATHY DECOMPRESSION TRIALOutcomes of IONDTResults of Clinical Severity MeasuresChapter 7: Brain Resuscitation Publisher SummaryEPIDEMIOLOGY AND NATURAL HISTORYDIAGNOSIS AND SUBPOPULATIONSCURRENT DISEASE MANAGEMENTGOLD AND SILVER STANDARDSCONCLUSIONChapter 8: Clinical Trials in Brain Injury After Cardiac Arrest Publisher SummaryEPIDEMIOLOGYRESEARCH AND PRACTICE INITIATIVESPATHOPHYSIOLOGYSECONDARY BRAIN INJURIES AFTER CARDIAC ARRESTFUTURE DIRECTIONSCLINICAL EDUCATION AND TRIAL NETWORKSChapter 9: Efficient Dose-Response Finding Strategies for Acute Neuroemergency Treatments Publisher SummaryBACKGROUND: THE ASTIN STUDYGENERALIZED ADAPTIVE DOSE ALLOCATION TOOLEFFICACY AND FUTILITYSIMULATING A STROKE TRIALADAPTIVE ALLOCATIONWHAT NEXT?ACKNOWLEDGMENTChapter 10: Biostatistical Issues in Neuroemergency Clinical Trials Publisher SummaryDIAGNOSIS AND SUBPOPULATIONSDOSING AND TIMING CONSIDERATIONSWIN-NO WIN RULESSTATISTICAL PLANNING CONSIDERATIONSSELECTION BIASHANDLING INCOMPLETE DATASEQUENTIAL ANALYSIS AND STOPPING RULESDATA ANALYSIS CONSIDERATIONSUNRESOLVED BIOSTATISTICAL ISSUESCONCENTRATION-OUTCOME RELATIONSHIPSSURROGATE ENDPOINTSADAPTIVE TRIAL DESIGNSARE LARGE PRAGMATIC TRIALS NECESSARY?Chapter 11: Data Safety and Monitoring Board: Role in Acute Neurological Trials Publisher SummaryDSMBs IN NEUROEMERGENCIESDSMB CHARTERINTERACTIONSChapter 12: Role of a Project Medical Officer in Acute Neuroemergency Clinical Trials Publisher SummaryPMO QUALIFICATIONSSTUDY DESIGN AND IMPLEMENTATIONTHERAPEUTIC TRAINING FOR SPONSOR'S STAFFSITE SELECTIONMANAGING EMERGING SITE ISSUES DURING ENROLLMENTMANAGING SITE INITIATION PROCESS AND BOOSTER ACTIVITIESGUIDING SAE AND CRF COMPLETION ISSUESSUMMARYChapter 13: Ethical Considerations in Neuroemergency Clinical Trials Publisher SummarySTUDY DESIGN CONSIDERATIONSEVALUATION OF A THERAPEUTIC HYPOTHESISINFORMED CONSENT PROCEDURESEMERGENCY RESEARCH CONSENT WAIVERRESEARCH INVOLVING CHILDRENOTHER CONSENT MECHANISMSDEFERRED CONSENTFINANCIAL COMPENSATION ISSUESIMPORTANT RESOURCES FOR RESEARCH ETHICS TRAININGChapter 14: Industry Perspective on Drug Development Publisher SummaryANIMAL MODELSTIME WINDOW, GLUCOSE, TEMPERATURE, AND BRAIN COMPOSITIONUNMET MEDICAL NEEDS AND DRUG DEVELOPMENTINDUSTRIAL INVESTMENT AND PRODUCTIVITYDECREASED RESEARCH PRODUCTIVITYChapter 15: Regulatory Perspective Publisher SummaryINVESTIGATIONAL NEW DRUG APPLICATIONSCOMMUNICATING WITH THE FDAFAST TRACK DEVELOPMENT PROGRAMSACCELERATED APPROVALSUBPART E PROGRAMSPRIORITY REVIEWORPHAN PRODUCT DESIGNATIONIMAGING PROTOCOLSHEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT PRIVACY REGULATIONSLICENSE APPLICATION PROCESSPOSTAPPROVAL ISSUES: MARKETING, PATIENT REGISTRIES, ADVERTISING, AND PROMOTIONAL MATERIALSCONCLUSIONIndex
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