Principles and Practice of Emergency Research Response

Table of Contents

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   Book Overview
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   Chapter 1 1 Introduction
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   Chapter 2 2 Clinical Research on Infectious Diseases: An Overview
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   Chapter 3 3 Guiding Principles for Emergency Research Response
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   Chapter 4 4 Ethics of Pandemic Research
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   Chapter 5 4.1 In Practice: Vaccine Efficacy and Safety Testing—An Ethical Case for Individual Randomization
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   Chapter 6 4.2 In Practice: Research Ethics Committee Review in Public Health Emergencies
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   Chapter 7 5 Health Emergency Research amid Global Inequities: Some Considerations for Researchers
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   Chapter 8 6 Meeting Regulatory Criteria and Seeking Licensure: Medicines Development Before and During Public Health Emergencies
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    Chapter 9 7 Research, Sample, and Data Sharing During Outbreaks, Pandemics, and Beyond
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    Chapter 10 8 Building Biomedical Research Capacity in Low- and Middle-Income Countries: Why It Matters and Some of the Barriers to Success
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    Chapter 11 9 Laboratory Needs for Research Response
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    Chapter 12 10 Understanding How and Where Pathogens Emerge: Preparedness and Response for Zoonotic Diseases
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    Chapter 13 11 Accelerating Diagnostic Innovation for Pandemic Control
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    Chapter 14 12 Vaccine Candidates for Novel Pathogens
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    Chapter 15 12.1 In Focus: Novel Manufacturing Platforms for Pandemic Preparedness and Emergency Response
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    Chapter 16 13 Accelerating Vaccine Development: The 100 Days Mission
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    Chapter 17 14 Accelerating Development of Therapeutics for Preparedness, Response, and a More Secure World
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    Chapter 18 14.1 In Practice: RECOVERY Trial
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    Chapter 19 15 ACTIV: A U.S. Public-Private Partnership Responds to COVID-19
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    Chapter 20 15.1 In Practice: Leveraging an Integrated National Health System for Research Response—The UK National Institute for Health Research Respiratory Translational Research Collaboration
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    Chapter 21 16 Challenges for Emergency Research Response and Preparedness in Fragile, Weak, and Failed Nation States
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    Chapter 22 16.1 In Practice: Responding to an Infectious Disease Outbreak amid a Humanitarian Emergency
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    Chapter 23 17 Integrating Clinical Research into Ebola Response: Liberia Case Study
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    Chapter 24 17.1 In Practice: Integration of Clinical Research and Patient Care in the DRC PALM Ebola Therapeutics Trial
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    Chapter 25 18 Good Participatory Practice: Social Mobilization, Communications, and Community Engagement
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    Chapter 26 18.1 In Practice: Building Community Engagement for Clinical Research Response
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    Chapter 27 18.2 18.2 In Practice: Adapting Social Analytics for Research Response
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    Chapter 28 19 Understanding and Reporting the Natural History of an Infectious Disease
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    Chapter 29 20 Turning Research Results into Clinical Practice Guidelines in Public Health Emergencies
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    Chapter 30 21 Epidemiologic Research in the Setting of Outbreak Response
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    Chapter 31 21.1 In Focus: The Impact and Mechanisms of Superspreading
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    Chapter 32 22 Vaccine Trial Designs
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    Chapter 33 22.1 In Focus: Ring Trial Design
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    Chapter 34 23 Data and Safety Monitoring of Clinical Trials During Public Health Emergencies
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    Chapter 35 23.1 In Practice: Monitoring the PALM Ebola Therapeutics Study in the Democratic Republic of the Congo
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    Chapter 36 24 Mathematical Modeling for Emergency Response: Using Models to Inform and Direct Response Priorities and Shape the Research Agenda
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    Chapter 37 25 Models in the COVID-19 Pandemic
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    Chapter 38 25.1 Case Study: Modeling Fractional-Dose Emergency Vaccination Campaigns for Yellow Fever
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    Chapter 39 26 Social Science Evidence for Outbreak and Pandemic Response: Rapid Research and Analytics for Public Health Emergencies
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    Chapter 40 27 A Global Framework for Research Preparedness and Response
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    Chapter 41 28 Financing Emergency Research Response During Infectious Disease Outbreaks: Lessons from the World Bank and Other International Financial Institutions
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    Chapter 42 29 International Collaboration to Advance Research Preparedness and Response
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    Chapter 43 30 Organizational Partnerships for Preparedness and Response to Emerging and Re-emerging Infectious Diseases
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    Chapter 44 30.1 In Focus: Research and Medical Humanitarian NGOs
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    Chapter 45 30.2 In Practice: Building and Maintaining Preparedness for a Rapid Research Response in Indonesia
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    Chapter 46 31 Operational Recommendations for Streamlining Emergency Research Responses to Pandemics
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    Chapter 47 32 Launching a Clinical Research Operation
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    Chapter 48 32.1 Case Study: Clinical Research Communications during an Outbreak: Media Outreach Supporting Liberia–U.S. Research Partnership
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    Chapter 49 32.2 In Focus: Clinical Trial Insurance and Indemnification
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    Chapter 50 33 Ethical Review of Clinical Research During an Emergency Response
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    Chapter 51 33.1 In Practice: Ethical Review During Emergencies: The Liberian Experience
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    Chapter 52 33.2 In Practice: Independent Monitoring of Emergency Response Clinical Trials
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    Chapter 53 33.3 In Practice: Capacity Building for Research Ethics Review in Low- and Middle-Income Countries
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    Chapter 54 34 Information and Communications Technology to Support Research in Low-Resource Settings
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    Chapter 55 35 Data Management in Emergency Response Research
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    Chapter 56 36 Safety and Pharmacovigilance in Emergency Research Response
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    Chapter 57 37 Supply and Logistics for Clinical Research in Low-Resource Settings
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    Chapter 58 38 Pharmaceutical Management
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    Chapter 59 39 Cold Chain and Electrical Power for Emergency Research Response
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    Chapter 60 40 Selecting and Opening a Clinical Research Site in a Low-Resource Setting
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    Chapter 61 40.1 In Practice: Improving Patient Care in the Field: The CUBE Isolation Unit
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    Chapter 62 41 Management of Security for Clinical Trials During Emergencies
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    Chapter 63 42 Locally Hired Staff for Clinical Research Sites in Low-Resource Settings