Integrating Clinical Research into Epidemic Response: The Ebola Experience

by National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Board on Global Health, Committee on Clinical Trials During the 2014-2015 Ebola Outbreak

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

Editorial Reviews

Reviewer: Michael Anthony Pentella, BS, MS, PhD (University of Iowa College of Public Health)
Description: This book is a consensus report from the Committee on Clinical Trials During the 2014-2015 Ebola Outbreak, which was formed by the National Academies of Sciences, Engineering, and Medicine. The report reviews the scientific and ethical issues related to clinical trial design, conduct, and reporting.
Purpose: This consensus report serves as a historical record of the events occurring during the 2014-2015 epidemic. It reviews the challenges to clinical research that the epidemic presented in order to understand what happened and recognizes difficulties in study design and implementation during the epidemic. The purpose of the report is to improve the clinical research process for the next epidemic. This is extremely worthwhile, since much can be learned from clinical trials during an epidemic of Ebola or other rarely occurring yet deadly infectious disease. This book meets the objectives of the committee by presenting the findings of the committee, conclusions and recommendations that will be useful in the future.
Audience: While the authors do not indicate the intended audience, there is a wide audience of practitioners in global health, public health, clinical research, therapeutics research, vaccine research, emergency response, and students. The committee co-chairs and committee members are all experts in the field.
Features: The focus of this book is the clinical trials for investigational therapeutic and vaccine candidates for Ebola conducted during the 2014-2015 epidemic in Guinea, Liberia, and Sierra Leone. The first chapter reviews the history of Ebola with special emphasis on the epidemic of 2014-2015 and the response to the epidemic. The authors describe the charge to the committee and the study scope. The second chapter deals with conducting clinical research during an epidemic since research is not seen as the primary challenge, but secondary to the public health emergency issues. Assessment of therapeutic and vaccine trials are dealt with in the third and fourth chapters. The authors describe study design and discuss why specific designs were selected and provide the results of the studies. In chapter 5, the authors describe the importance and need to strengthen capacity for response and research based on the Ebola epidemic experience. In chapter 6, the important aspect of engaging communities in research and response are reviewed. The authors conclude in chapter 7 with a discussion of the importance of facilitating international coordination and collaboration. To perform clinical research during the epidemic was a tremendous accomplishment that required the collaboration of many researchers, governments, scientific review boards, and communities to work under very tight timelines. There are many lessons to be learned from the Ebola epidemic experience and this book successfully describes the scientific accomplishments and future challenges. Each chapter ends with a summary conclusion and is well referenced. The book has many tables, figures, summary boxes, and other graphics, including some in color, that make it an easier reading experience. Four appendixes describe the meetings that were held and provide biographies of the committee members.
Assessment: As someone who worked in public health in the United States during the Ebola epidemic of 2014-2015, I found this book very interesting. It provided me with a larger perspective of the important work that was occurring to have effective therapeutics and prevent future epidemics through vaccination. While the focus is the Ebola epidemic, many of the lessons learned can be applied to future outbreaks of emerging pathogens. This book is unique because of the process to examine the experience and make recommendations for the future.

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