ISBN-10:
0309457769
ISBN-13:
9780309457767
Pub. Date:
07/26/2017
Publisher:
National Academies Press

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Overview

The 2014—2015 Ebola epidemic in western Africa was the longest and most deadly Ebola epidemic in history, resulting in 28,616 cases and 11,310 deaths in Guinea, Liberia, and Sierra Leone. The Ebola virus has been known since 1976, when two separate outbreaks were identified in the Democratic Republic of Congo (then Zaire) and South Sudan (then Sudan). However, because all Ebola outbreaks prior to that in West Africa in 2014—2015 were relatively isolated and of short duration, little was known about how to best manage patients to improve survival, and there were no approved therapeutics or vaccines. When the World Heath Organization declared the 2014-2015 epidemic a public health emergency of international concern in August 2014, several teams began conducting formal clinical trials in the Ebola affected countries during the outbreak.

Integrating Clinical Research into Epidemic Response: The Ebola Experience assesses the value of the clinical trials held during the 2014—2015 epidemic and makes recommendations about how the conduct of trials could be improved in the context of a future international emerging or re-emerging infectious disease events.

Product Details

ISBN-13: 9780309457767
Publisher: National Academies Press
Publication date: 07/26/2017
Pages: 342
Product dimensions: 6.00(w) x 9.00(h) x 0.90(d)

Table of Contents

Acronyms and Abbreviations xxiii

Summary 1

Study Charge and Approach 2

Assessment of Ebola Clinical Trials 3

Ethics of Clinical Research During an Epidemic 6

Recommendations 8

Being Prepared: Launching Clinical Trials in an Epidemic 18

1 Introduction 19

Charge to the Committee and Study Scope 22

Study Methodology 24

Context of the 2014-2015 Ebola Epidemic 24

Organization of the Report 32

References 33

2 Conducting Clinical Research During an Epidemic 37

Early Debates About Use of Products 39

Planning Clinical Trials 43

Ethical Perspectives 52

Conclusions 72

References 75

3 Assessment of Therapeutic Trials 83

Discussion 96

References 108

4 Assessment of Vaccine Trials 113

Assessment of Trials 117

Overall Assessment of Vaccines 139

References 151

5 Strengthening Capacity for Response and Research 155

Capacity Challenges to Conducting Clinical Research 158

Integration of Research into Health Systems 183

References 190

6 Engaging Communities in Research and Response 199

Engaging Communities in Response 202

Engaging Communities in Research 205

The Role of Communication 214

Summary 217

References 219

7 Facilitating International Coordination and Collaboration 223

Inter-epidemic Period 225

During an Epidemic 236

Embedding Research into Response 246

Summary 247

References 248

Appendixes

A Study Approach and Methods 251

B Clinical Trial Designs 287

C Ethical Principles for Research with Human Subjects 297

D Biographical Sketches of Committee Members and Staff 301

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