Principles and Practice of Emergency Research Response
portes grátis
Principles and Practice of Emergency Research Response
Smith, Peter G.; McNay, Laura A.; Lurie, Nicole; Higgs, Elizabeth S.; Fallah, Mosoka P.; Sorenson, Robert A.
Springer International Publishing AG
09/2024
1100
Dura
Inglês
9783031484070
15 a 20 dias
Descrição não disponível.
Section I. Pandemic Preparedness and Research Response: A Necessary New Field.- 1. Introduction.- 2. Clinical Research on Infectious Diseases.- 3. Guiding Principles for Emergency Research Response.- Section II. Norms for Emergency Research Response.- 4. Ethics of Pandemic Research.- 4.1. In Practice: Vaccine Efficacy and Safety Testing - An Ethical Case for Individual Randomization.- 4.2. In Practice: Research Ethics Committee Review in Public Health Emergencies.- 5. Health Emergency Research amid Global Inequities.- 6. Meeting Regulatory Criteria and Seeking Licensure.- 7. Research, Sample, and Data Sharing During Outbreaks, Pandemics, and Beyond.- Section III. Preparedness for Emergency Research Response.- 8. Building Biomedical Research Capacity in Low- and Middle-Income Countries.- 9. Laboratory Needs for Research Response.- 10. Understanding How and Where Pathogens Emerge.- 11. Accelerating Diagnostic Innovation for Pandemic Control.- 12. Vaccine Candidates for Novel Pathogens.-12.1. In Focus: Novel Manufacturing Platforms for Pandemic Preparedness and Emergency Response.- 13. Accelerating Vaccine Development.- 14. Accelerating Development of Therapeutics for Preparedness, Response, and a More Secure World.- 14.1. In Practice: The RECOVERY Trial.- Section IV. Research Response.- 15. ACTIV: A U.S. Public-Private Partnership Responds to COVID-19.- 15.1. In Practice: Leveraging an Integrated National Health System for Research Response.- 16. Challenges for Emergency Research Interventions in Fragile, Weak, and Failed Nation States.- 16.1. In Practice: Responding to an Infectious Disease Outbreak amid a Humanitarian Emergency.- 17. Integrating Clinical Research into Ebola Response: Liberia Case Study.- 17.1. In Practice: Integration of Clinical Research and Patient Care in the DRC PALM Ebola Therapeutics Trial.- 18. Good Participatory Practice. Social Mobilization, Communications, and Community Engagement.- 18.1. In Practice: Building Community Engagement for Clinical Research Response.- 18.2. In Practice: Adapting Social Analytics for Research Response.- 19. Understanding and Reporting the Natural History of an Infectious Disease.- 20. Turning Research Results into Clinical Practice Guidelines in Public Health Emergencies.- Section V. Methodology for Research Response.- 21. Epidemiological Research in the Setting of Outbreak Response.- 21.1. In Focus: The Impact and Mechanisms of Superspreading.- 22. Vaccine Trial Designs.- 22.1. In Focus: Ring Trial Design.- 23. Data and Safety Monitoring of Clinical Trials During Public Health Emergencies.- 23.1. In Practice: Monitoring the PALM Ebola Therapeutics Study in the Democratic Republic of the Congo.- 24. Mathematical Modeling for Emergency Response.- 25. Models in the COVID-19 Pandemic.- 25.1. Case Study: Modeling Fractional-Dose Emergency Vaccination Campaigns for Yellow Fever.- 26. Social Science Evidence for Outbreak and Pandemic Response.- Section VI. Governance, Institutions, and Partnerships.- 27. A Global Framework for Research Preparedness and Response.- 28. Financing Emergency Research Response during Infectious Disease Outbreaks.- 29. International Collaboration to Advance Research Preparedness and Response.- 30. Organizational Partnerships for Preparedness and Response to Emerging and Re-Emerging Infectious Diseases.- 30.1. In Focus: Research and Medical Humanitarian NGOs.- 30.2. In Practice: Building and Maintaining Preparedness for a Rapid Research Response in Indonesia.- Section VII. Research Operations.- 31. Operational Recommendations for Streamlining Emergency Research Responses to Pandemics.- 32. Launching a Clinical Research Operation.- 32.1. In Practice: Clinical Research Communications During an Outbreak.- 32.2. In Focus: Clinical Trial Insurance and Indemnification.- 33. Ethical Review of Research During an Emergency Response.- 33.1. In Practice: Ethical Review During Emergencies - The Liberian Experience.- 33.2. In Practice: Independent Monitoring of Emergency Response Clinical Trials.- 33.3. In Practice: Capacity Building for Research Ethics Review in Low- and Middle-Income Countries.- 34. Information and Communications Technology to Support Research Low-Resource Settings.- 35. Data Management in Emergency Response Research.- 36. Safety and Pharmacovigilance in Emergency Research Response.- 37. Supply and Logistics for Clinical Research in Low-Resource Settings.- 38. Pharmaceutical Management.- 39. Cold Chain and Electrical Power for Emergency Research Response.- 40. Selecting and Opening a Clinical Research Site in a Low-Resource Setting.- 40.1. In Practice: Improving Patient Care in the Field - The CUBE Isolation Unit.- 41. Management of Security for Clinical Trials During Emergencies.- 42. Locally Hired Staff for Clinical Research Sites in Low-Resource Settings.
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Bioethics;public health;medical NGO;ODA;international assistance;emergency response;health system;global health;humanitarian response;open access;COVID-19;SARS-CoV-2;ebola;zoonotic;clinical research;preparation;health security
Section I. Pandemic Preparedness and Research Response: A Necessary New Field.- 1. Introduction.- 2. Clinical Research on Infectious Diseases.- 3. Guiding Principles for Emergency Research Response.- Section II. Norms for Emergency Research Response.- 4. Ethics of Pandemic Research.- 4.1. In Practice: Vaccine Efficacy and Safety Testing - An Ethical Case for Individual Randomization.- 4.2. In Practice: Research Ethics Committee Review in Public Health Emergencies.- 5. Health Emergency Research amid Global Inequities.- 6. Meeting Regulatory Criteria and Seeking Licensure.- 7. Research, Sample, and Data Sharing During Outbreaks, Pandemics, and Beyond.- Section III. Preparedness for Emergency Research Response.- 8. Building Biomedical Research Capacity in Low- and Middle-Income Countries.- 9. Laboratory Needs for Research Response.- 10. Understanding How and Where Pathogens Emerge.- 11. Accelerating Diagnostic Innovation for Pandemic Control.- 12. Vaccine Candidates for Novel Pathogens.-12.1. In Focus: Novel Manufacturing Platforms for Pandemic Preparedness and Emergency Response.- 13. Accelerating Vaccine Development.- 14. Accelerating Development of Therapeutics for Preparedness, Response, and a More Secure World.- 14.1. In Practice: The RECOVERY Trial.- Section IV. Research Response.- 15. ACTIV: A U.S. Public-Private Partnership Responds to COVID-19.- 15.1. In Practice: Leveraging an Integrated National Health System for Research Response.- 16. Challenges for Emergency Research Interventions in Fragile, Weak, and Failed Nation States.- 16.1. In Practice: Responding to an Infectious Disease Outbreak amid a Humanitarian Emergency.- 17. Integrating Clinical Research into Ebola Response: Liberia Case Study.- 17.1. In Practice: Integration of Clinical Research and Patient Care in the DRC PALM Ebola Therapeutics Trial.- 18. Good Participatory Practice. Social Mobilization, Communications, and Community Engagement.- 18.1. In Practice: Building Community Engagement for Clinical Research Response.- 18.2. In Practice: Adapting Social Analytics for Research Response.- 19. Understanding and Reporting the Natural History of an Infectious Disease.- 20. Turning Research Results into Clinical Practice Guidelines in Public Health Emergencies.- Section V. Methodology for Research Response.- 21. Epidemiological Research in the Setting of Outbreak Response.- 21.1. In Focus: The Impact and Mechanisms of Superspreading.- 22. Vaccine Trial Designs.- 22.1. In Focus: Ring Trial Design.- 23. Data and Safety Monitoring of Clinical Trials During Public Health Emergencies.- 23.1. In Practice: Monitoring the PALM Ebola Therapeutics Study in the Democratic Republic of the Congo.- 24. Mathematical Modeling for Emergency Response.- 25. Models in the COVID-19 Pandemic.- 25.1. Case Study: Modeling Fractional-Dose Emergency Vaccination Campaigns for Yellow Fever.- 26. Social Science Evidence for Outbreak and Pandemic Response.- Section VI. Governance, Institutions, and Partnerships.- 27. A Global Framework for Research Preparedness and Response.- 28. Financing Emergency Research Response during Infectious Disease Outbreaks.- 29. International Collaboration to Advance Research Preparedness and Response.- 30. Organizational Partnerships for Preparedness and Response to Emerging and Re-Emerging Infectious Diseases.- 30.1. In Focus: Research and Medical Humanitarian NGOs.- 30.2. In Practice: Building and Maintaining Preparedness for a Rapid Research Response in Indonesia.- Section VII. Research Operations.- 31. Operational Recommendations for Streamlining Emergency Research Responses to Pandemics.- 32. Launching a Clinical Research Operation.- 32.1. In Practice: Clinical Research Communications During an Outbreak.- 32.2. In Focus: Clinical Trial Insurance and Indemnification.- 33. Ethical Review of Research During an Emergency Response.- 33.1. In Practice: Ethical Review During Emergencies - The Liberian Experience.- 33.2. In Practice: Independent Monitoring of Emergency Response Clinical Trials.- 33.3. In Practice: Capacity Building for Research Ethics Review in Low- and Middle-Income Countries.- 34. Information and Communications Technology to Support Research Low-Resource Settings.- 35. Data Management in Emergency Response Research.- 36. Safety and Pharmacovigilance in Emergency Research Response.- 37. Supply and Logistics for Clinical Research in Low-Resource Settings.- 38. Pharmaceutical Management.- 39. Cold Chain and Electrical Power for Emergency Research Response.- 40. Selecting and Opening a Clinical Research Site in a Low-Resource Setting.- 40.1. In Practice: Improving Patient Care in the Field - The CUBE Isolation Unit.- 41. Management of Security for Clinical Trials During Emergencies.- 42. Locally Hired Staff for Clinical Research Sites in Low-Resource Settings.
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