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Integrating Clinical Research into Epidemic Response: The Ebola Experience (2017)

Chapter: Appendix A: Study Approach and Methods

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Suggested Citation:"Appendix A: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Integrating Clinical Research into Epidemic Response: The Ebola Experience. Washington, DC: The National Academies Press. doi: 10.17226/24739.
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Appendix A

Study Approach and Methods

In response to a request by the Office of the Assistant Secretary for Preparedness and Response, the National Institute of Allergy and Infectious Disease, and the Food and Drug Administration of the U.S. Department of Health and Human Services, the National Academies of Sciences, Engineering, and Medicine’s Committee on Clinical Trials During the 2014–2015 Ebola Outbreak was charged with exploring the scientific and ethical issues related to clinical trials conducted in Guinea, Liberia, and Sierra Leone between 2014 and 2015. The committee’s final report will inform guidelines and best practices for the design, conduct, and reporting of clinical trials in response to a future outbreak.

COMMITTEE EXPERTISE

The National Academies formed a committee of 16 experts to conduct an 18-month study to deliberate and respond to the statement of task. The committee was composed of individuals with expertise in clinical trial investigations and ethics review committees experience, international health law, regulatory and health systems oversight, public engagement and local/ community and cultural perspectives, biostatistics and clinical trial design, clinical infectious disease science and case management, crisis management, and emergency preparedness and response. Representation included U.S., European, and African participants as well as a consultant on clinical trial methodology, Janet Darbyshire.

Suggested Citation:"Appendix A: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Integrating Clinical Research into Epidemic Response: The Ebola Experience. Washington, DC: The National Academies Press. doi: 10.17226/24739.
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MEETINGS AND INFORMATION-GATHERING ACTIVITIES

The committee deliberated from January to December 2016, during the course of which it held six in-person meetings (February, March, June, August, September, and November). The February, March, June, and August meetings included portions open to the public, and the open session agendas for those sessions appear below. The committee meetings in September and November were held only in closed session.

To inform its deliberations the committee gathered information through a variety of mechanisms: (1) three 3-day workshops with open public sessions; (2) one 2-hour webinar in May with international regulators; (3) one open public comment session during its June meeting; (4) systematic literature reviews of the scientific, ethical, social, and anthropological issues and other pertinent background research; (5) solicitation and consideration of written statements from stakeholders and members of the public through the committee’s Current Projects System website and committee e-mail; and (6) personal communication between committee members and staff and individuals who have been directly involved in or have special knowledge of the issues under consideration.

IDENTIFYING WEST AFRICAN EXPERTS FOR A LOCAL PERSPECTIVE

The committee held a 2-day public workshop in August 2016 in Monrovia, Liberia, where it spoke with local experts from Guinea, Liberia, and Sierra Leone knowledgeable about scientific research, ethical review and pharmaceutical regulations, Ebola clinical care, survivors of Ebola, and social mobilization and gathered their input on a wide range of topics related to the committee’s charge, including (1) the clinical trials conducted during the Ebola outbreak, (2) ethical and social implications of clinical trials being conducted in the three countries, (3) the role of the community in implementing clinical trials, and (4) inter-epidemic planning. Participants for this public workshop were identified through conversations with committee members, anthropologists who worked in country, suggestions from trial sponsors, and published news and literature discussing pertinent players during the Ebola outbreak. This meeting included an open public comment session during which input was invited from any interested parties.

TRIAL ANALYSIS

As part of the statement of task, the committee was asked to assess the scientific validity of the information that arose as a result of the clinical trials conducted during the 2014–2015 Ebola outbreak. While numerous

Suggested Citation:"Appendix A: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Integrating Clinical Research into Epidemic Response: The Ebola Experience. Washington, DC: The National Academies Press. doi: 10.17226/24739.
×

attempts to study investigational agents occurred in West Africa during this time including through compassionate use, observational studies, and other investigations of therapies that lacked sufficient detail on protocol or results—the trials assessed by the committee were chosen based on the trial location (Guinea, Liberia, or Sierra Leone) and on whether or not a formal clinical trial was conducted. The committee reviewed the trials based on available trial results in the literature as well as on other publications or presentations that addressed the scientific, ethical, and logistical considerations of each trial team.

LITERATURE AND PRESS REVIEW

The committee and staff conducted a literature search that was concentrated on journals found in the following databases: Medline, Embase, PubMed, Scopus, Web of Science, Anthropology Plus, Proquest, African Journals Online, African Index Medicus, ClinicalTrials.gov, and Northern Light. Broad search terms were used to cast as wide a net as possible. The articles obtained by use of the search terms were reviewed for their relevance to the committee’s charge. Other targeted literature reviews were conducted throughout the committee’s deliberations as novel issues arose.

Clinical Trial Design and Conduct

Search Parameters:

  • Date range: all years
  • International, English only

Databases:

  • Scopus
  • Web of Science
  • Embase and Medline
  • Proquest
  • Northern Light

Search Strategy:

Adaptive Clinical Trials

  • TITLE-ABS (“clinical trial” AND (“adaptive randomized trial” OR “adaptive trial” OR “platform trial*” OR “new Bayesian” OR “Bayesian adaptive” OR “Bayesian meta-analysis”))

Historical Controls

  • TITLE ((“historical”) AND (“randomized clinical trial” OR “randomized trial” OR rct OR “clinical trial”))
Suggested Citation:"Appendix A: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Integrating Clinical Research into Epidemic Response: The Ebola Experience. Washington, DC: The National Academies Press. doi: 10.17226/24739.
×

Clinical Trials During Outbreaks

  • TITLE-ABS((“infectious disease” or ebola or cholera or AIDS or HIV or “avian flu” or “avian influenza” or MERS or “Middle East respiratory syndrome” or “Marburg virus” or “viral haemorrhagic fever” or Legionnaires or “meningococcal disease” or “acute haemorrhagic fever syndrome” or SARS or “severe acute respiratory syndrome”)) w/10 outbreak and “clinical trial*”)

Ethics of Randomization

  • TITLE ((ethics OR ethical) AND randomization) OR ABS ((ethics OR ethical) AND randomization) AND TITLE-ABS-KEY (“high risk” OR “infectious disease” OR “high mortality”))

Informed Consent

  • (informed consent or consent or informed decision).mp. AND (understanding or comprehension or retention or knowledge or awareness or recall).mp. AND (biomedical research or clinical research or clinical trials or randomi*ed controlled clinical trials or random allocation trials or intervention trials).mp. AND Africa/ OR (lowincome countr* or developing countr* or vulnerable populations or disadvantaged populations or underserved populations).mp.

Clinical Trials in Developing Countries

  • randomization and ethics and (Asia or Africa or Thailand or “developing countr*”)

Anthropology

Search Parameters:

  • Date range: all years;
  • International, English only

Databases:

Search Strategy:

Compassionate Use

  • Search terms: compassionate use, undue inducement, standard of care Ebola, community engagement, informed consent

Community Acceptance of Clinical Trials

  • Search terms: Ebola, therapeutic misconception, consent, community engagement, clinical trial, Ebola treatment unit, vaccination, consent, surveillance, quarantine
Suggested Citation:"Appendix A: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Integrating Clinical Research into Epidemic Response: The Ebola Experience. Washington, DC: The National Academies Press. doi: 10.17226/24739.
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PUBLIC COMMITTEE MEETING AGENDAS

Meeting 1: Washington, DC; February 22–23

Public Workshop of the Committee on Clinical Trials During the 2014–2015 Ebola Outbreak

First Committee Meeting
February 22–23, 2016
Keck Center: 500 Fifth Street, NW
Washington, DC 20001
Room 100

Day 1
Monday, February 22

CLOSED COMMITTEE SESSION
8:00 a.m.–4:00 p.m.

OPEN SESSION

4:00 p.m. Opening Remarks to Public Audience
  • Gerald Keusch, Committee Co-Chair, Professor of Medicine and International Health, Boston University Schools of Medicine and Public Health
  • Keith McAdam, Committee Co-Chair, Emeritus Professor of Clinical and Tropical Medicine, London School of Hygiene & Tropical Medicine

4:05 p.m. Delivery of Study Charge and Q&A/Discussion with Committee
Objectives:
  • Receive study background and charge from the U.S. National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIH–NIAID).
  • Discuss task with the sponsor and determine scope of committee’s work (i.e., what is in and what is out).
  • Clarify issues identified by the committee and seek answers to questions.
  • Discuss report audience and expected products.
Suggested Citation:"Appendix A: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Integrating Clinical Research into Epidemic Response: The Ebola Experience. Washington, DC: The National Academies Press. doi: 10.17226/24739.
×
Moderators: Gerald Keusch and Keith McAdam, Committee Co-Chairs
Sponsor Panelists:
  • Tony Fauci, Director, NIAID
  • Cliff Lane, Deputy Director for Clinical Research and Special Projects; Director, Division of Clinical Research, NIAID
5:00 p.m. ADJOURN Open Session
Day 2
Tuesday, February 23
OPEN SESSION
9:00 a.m. Opening Remarks to Public Audience
  • Gerald Keusch, Committee Co-Chair, Professor of Medicine and International Health, Boston University Schools of Medicine and Public Health
  • Keith McAdam, Committee Co-Chair, Emeritus Professor of Clinical and Tropical Medicine, London School of Hygiene & Tropical Medicine

9:05 a.m. Delivery of Study Charge and Q&A/Discussion with Committee
Objectives:
  • Receive study background and charge from the Office of the Assistant Secretary for Preparedness and Response (ASPR) and the U.S. Food and Drug Administration (FDA).
  • Discuss task with the sponsor and determine scope of committee’s work (i.e., what is in and what is out).
  • Clarify issues identified by the committee and seek answers to questions.
  • Discuss report audience and expected products.
Moderators: Gerald Keusch and Keith McAdam, Committee Co-Chairs
Suggested Citation:"Appendix A: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Integrating Clinical Research into Epidemic Response: The Ebola Experience. Washington, DC: The National Academies Press. doi: 10.17226/24739.
×
Sponsor Panelists:
  • Nicole Lurie, Assistant Secretary for Preparedness and Response, Office of the Assistant Secretary for Preparedness and Response (ASPR)
  • Luciana Borio, Acting Chief Scientist, U.S. Food and Drug Administration (FDA)

10:00 a.m. ADJOURN Open Session
CLOSED COMMITTEE SESSION
10:00 a.m. – 4:00 p.m.
Suggested Citation:"Appendix A: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Integrating Clinical Research into Epidemic Response: The Ebola Experience. Washington, DC: The National Academies Press. doi: 10.17226/24739.
×

Meeting 2: London, UK; March 22–24

Public Workshop of the Committee on Clinical Trials During the 2014–2015 Ebola Outbreak

Second Committee Meeting
March 22–24, 2016
British Medical Association
BMA House
Tavistock Square
London WC1H 9JP
United Kingdom

Day 1
Tuesday, March 22, 2016

Meeting Objectives:
  • Explore the design and implementation of clinical trials during the 2014–2015 Ebola outbreak.
  • Examine the cultural, public health, and ethical context surrounding the respective designs of Ebola clinical trials; highlight important takeaways for future trials in a similar emergency context.
  • Discuss the scientific and public health gains from clinical trials during the Ebola outbreak and identify lessons learned to improve a future international response to a public health emergency in a low-resourced country.
  • Consider the role of international bodies (governments, regulatory agencies, nongovernmental organizations, academicians, and others) in a rapid, robust, and sustained response.
9:45 a.m. Welcome by Committee Co-Chairs
  • Keith McAdam, Committee Co-Chair, Emeritus Professor of Clinical and Tropical Medicine, London School of Hygiene & Tropical Medicine
  • Gerald Keusch, Committee Co-Chair, Professor of Medicine and International Health, Boston University Schools of Medicine and Public Health
Suggested Citation:"Appendix A: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Integrating Clinical Research into Epidemic Response: The Ebola Experience. Washington, DC: The National Academies Press. doi: 10.17226/24739.
×
10:00 a.m. Opening Presentation: Presentation and Q&A
Bridging the Divide: Connecting Clinician, Patient, and Researcher
  • Ian Crozier, Infectious Disease Specialist, Physician
SESSION I – PERSPECTIVES ON THE COMMUNICATION OF CLINICAL RESEARCH DURING AN EMERGENCY
(60 min; 10-min panelist presentations followed by 30-min discussion and Q&A)
10:30 a.m. Objectives:
  • Explore the role of public trust and rumor management in the communication and implementation of clinical trials.
  • Examine how local understanding of existing clinical care and clinical research influence community acceptance of trials.
Moderator: Sheila Davis, Chief Nursing Officer, Partners In Health
Panelists:
  • James Fairhead, Chair, Social Anthropology, University of Sussex
  • Heidi Larson, Senior Lecturer, London School of Hygiene & Tropical Medicine
SESSION II – CLINICAL TRIAL DESIGN AND IMPLEMENTATION: REFLECTIONS ON THE CLINICAL TRIALS CONDUCTED DURING THE 2014–2015 EBOLA OUTBREAK
(Session II will consist of three panels and extend after lunch; speakers are encouraged to stay throughout the entire session)
Objectives:
  • Discuss the considerations that were taken into account in the design of the trial (i.e., meeting scientific and ethical standards, health systems infrastructure, time to trial launch, public opinion, need of the affected population, etc.).
Suggested Citation:"Appendix A: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Integrating Clinical Research into Epidemic Response: The Ebola Experience. Washington, DC: The National Academies Press. doi: 10.17226/24739.
×
  • Discuss any alternative trial designs considered leading up to implementation of the trial; explore why particular designs were selected.
  • Explore the role of the trialist, if any, in selecting the interventions used in the EVD trials; discuss the considerations that go into advancing experimental compounds into clinical trials.
  • Discuss the trial results, where available, and explore the scientific and public health value in the data derived from each study. What, if anything, would you do differently next time to achieve greater gains from trials?
Moderators: Janet Darbyshire, Emeritus Professor of Epidemiology, University College London; and Abdel Babiker, Professor of Epidemiology and Medical Statistics, Medical Research Council Clinical Trials Unit, University College London
11:30 a.m. Overview Presentation (20 mins):
  • Peter Smith, Professor, London School of Hygiene & Tropical Medicine
11:50 a.m. Panel 2A. Vaccine Trials Conducted During the Ebola Outbreak
(60 min; 10-min panelist presentations followed by 40-min discussion and Q&A)
Panelists:
  • Johan van Hoof, Global Therapeutic Area Head, Infectious Diseases and Vaccines, Janssen Research & Development, LLC – EBOVAC-Salone
  • Ana Maria Henao-Restrepo, Medical Officer at the Initiative for Vaccine Research (IVR), Department of Immunization Vaccines and Biologicals, WHO – Guinea Ring Vaccine
12:50 p.m. LUNCH
Suggested Citation:"Appendix A: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Integrating Clinical Research into Epidemic Response: The Ebola Experience. Washington, DC: The National Academies Press. doi: 10.17226/24739.
×
1:50 p.m. Panel 2B. Therapeutic Trials Conducted During the Ebola Outbreak
(85 min; 10-min panelist presentations followed by 45-min discussion and Q&A)
Panelists:
  • Trudie Lang, Professor, University of Oxford
  • John Whitehead, Emeritus Professor, Lancaster University – RAPIDE-BCV, TKM-Ebola
  • Annick Antierens, Medical Department, Médecins Sans Frontières
  • Johan van Griensven, Professor, Institute of Tropical Medicine–Antwerp – Ebola-Tx
  • France Mentre, Professor of Biostatistics, Université Paris Diderot, Paris, France – JIKI
3:15 p.m. BREAK
3:30 p.m. Panel 2C. Panel Reflections and Considerations for the Design of Clinical Trials
(60 min; 10-min panelist presentations followed by 40-min discussion and Q&A)
Objectives:
  • Discuss lessons learned and explore how future approaches to clinical trials in a public health emergency may be similar and/or different.
  • Identify innovative approaches to research in emergency contexts; consider options that facilitate flexible and accelerated approaches.
  • Consider whether adjustments to research standards in an outbreak are appropriate.
Panelists:
  • Peter Smith, Professor, London School of Hygiene & Tropical Medicine
  • Geneviève Chêne, Professor, University of Bordeaux
Suggested Citation:"Appendix A: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Integrating Clinical Research into Epidemic Response: The Ebola Experience. Washington, DC: The National Academies Press. doi: 10.17226/24739.
×
SESSION III – PUBLIC HEALTH CONTEXT
(30 min; 10-min panelist presentation followed by 20-min discussion and Q&A)
4:30 p.m. Objectives:
  • Explore strategies for how different stakeholders (for example, nongovernmental organizations, clinicians, health ministers, and international researchers) could work together to address a public health emergency.
  • Consider how best incorporate research into the public health response in the event of an outbreak in a low-resource setting.
  • In the context of a public health emergency in a low-resource setting, examine where international organizations can best cooperate and invest to build sustainable in-country clinical research systems.
  • Discuss lessons learned from other outbreak situations (e.g., severe acute respiratory syndrome [SARS]) and explore how those experiences could have informed the Ebola response, reflect on strategies for applying lessons learned in the future.
Moderator: David Peters, Professor, Johns Hopkins Bloomberg School of Public Health
Panelist:
  • David Heymann, Head of the Centre on Global Health Security, Chatham House
5:00 p.m. ADJOURN
Suggested Citation:"Appendix A: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Integrating Clinical Research into Epidemic Response: The Ebola Experience. Washington, DC: The National Academies Press. doi: 10.17226/24739.
×

Day 2
Wednesday, March 23, 2016

SESSION IV – ETHICAL CONSIDERATIONS IN THE CONDUCT OF CLINICAL TRIALS DURING AN EMERGENCY

(60 min; 10-min presentations followed by 40-min discussion)

10:00 a.m. Objectives:
  • Explore how the ethical principles for clinical trial conduct are applied in a low-resource outbreak setting, consider:
    • Scientific validity and health value of the study
    • Fair subject selection and subject respect
    • Risk–benefit ratio; equipoise
    • Informed consent
  • Discuss how a public health emergency may impact the ethical considerations involved in clinical trial design and conduct—explore what, if any of the principles are inviolable.
Moderator: Olayemi Omotade, Professor of Pediatrics and Child Health, University of Ibadan
Panelists:
  • François Hirsch, Senior Research Director, Institut national de la santé et de la recherche médicale (Inserm)
  • Jonathan Montgomery, Professor of Health Care Law, University College London, Chair, Nuffield Council on Bioethics
CLOSED SESSION – COMMITTEE ONLY
11:15 a.m.–1:25 p.m.
SESSION V – PREPARING FOR AND FINANCING CLINICAL TRIALS
(60 min; 10-min panelist presentations followed by 40-min discussion and Q&A)
1:30 p.m. Objectives:
  • Explore how the broader research community can work together during the inter-epidemc period to prepare for and improve the execution of clinical trials.
Suggested Citation:"Appendix A: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Integrating Clinical Research into Epidemic Response: The Ebola Experience. Washington, DC: The National Academies Press. doi: 10.17226/24739.
×
  • Identify the biggest local and international roadblocks in designing and implementing clinical trials in West Africa. Discuss how international bodies be better situated to respond next time.
  • Consider methods to develop a sustainable research system, e.g., standard implementable clinical trial protocols, training local research staff, establishing regional health technologies and infrastructure.
  • Moderator: Fred Wabwire-Mangen, Associate Professor of Epidemiology and Public Health, Makerere University
Panelists:
  • Jimmy Whitworth, Professor, London School of Hygiene & Tropical Medicine
  • Marguerite Koutsoukos, Director Ebola and HIV programs, GlaxoSmithKline (GSK)
CLOSED SESSION – COMMITTEE ONLY
2:35 p.m.–3:15 p.m.
OPEN SESSION
3:30 p.m. Q&A with Jeremy Farrar, Director, Wellcome Trust
4:00 p.m. ADJOURN
Suggested Citation:"Appendix A: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Integrating Clinical Research into Epidemic Response: The Ebola Experience. Washington, DC: The National Academies Press. doi: 10.17226/24739.
×

Day 3
Thursday, March 24, 2016

SESSION VI – ETHICAL AND SCIENTIFIC CONSIDERATIONS FOR PRIORITIZING RESEARCH DURING OUTBREAKS
(60 min; 10-min panelist presentations followed by 40-min Q&A)

10:00 a.m. Objectives:
  • Explore what evidence is needed when evaluating potential treatment options to determine the most viable candidates for further development and advancement to clinical trials.
  • Discuss how, in the context of an international emerging or re-emerging infectious disease event, clinical trials can best be prioritized.
  • Explore the common goals and trade-offs in health care and clinical research.
Moderator: Alex John London, Professor, Carnegie Mellon University
Panelists:
  • Miles Carroll, Head of Research Microbiology Service, Public Health England (PHE)
  • Carel IJsselmuiden, Executive Director, Council on Health Research for Development (COHRED) Group, South Africa
11:00 a.m. ADJOURN
Suggested Citation:"Appendix A: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Integrating Clinical Research into Epidemic Response: The Ebola Experience. Washington, DC: The National Academies Press. doi: 10.17226/24739.
×

Meeting 3: Webinar; May 19

Public Webinar of the Committee on Clinical Trials During the 2014–2015 Ebola Outbreak

May WebEx Session: 2-Hour Webinar

May 19, 2016

REGULATORY CONSIDERATIONS

Meeting Objectives:
  • Discuss product regulators’ thinking about standards of evidence for approval of experimental products in a rapidly progressing infectious disease epidemic.
  • In situations involving multiple experimental agents at relatively early stages of development, consider how regulators should prioritize which agent to advance.
  • Identify the key considerations for prioritizing and implementing clinical trials when there is a limited supply of product available or (as in the waning of an outbreak) the potential for insufficient participants for a statistically valid analysis. Furthermore, is randomization imperative in this context?
  • Explore whether and how regulatory agencies, key funders, and other stakeholders in different countries can coordinate the assessment and implementation of clinical trials for experimental products during an infectious disease outbreak.
Panelists:
  • Robert Hemmings, Unit Manager, Statistics and Pharmacokinetics Unit, Medicines and Healthcare Products Regulatory Agency (MHRA), UK
  • Peter Marks, Director, Center for Biologics Evaluation and Research, U.S. FDA
  • Edward M. Cox, Director of Antimicrobial Products (OAP), U.S. FDA
  • Marco Cavaleri, Head of Anti-Infectives and Vaccines, European Medicine Agency
Suggested Citation:"Appendix A: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Integrating Clinical Research into Epidemic Response: The Ebola Experience. Washington, DC: The National Academies Press. doi: 10.17226/24739.
×
Hour 1: Welcome by Moderator and Speaker Introductions (5 min)
Moderator: Michelle Mello, Professor of Law and Professor of Health Research and Policy, Stanford University
Discussion: Standards of Evidence (45 min)
  • Each agency has 5 minutes for opening remarks followed by committee discussion and Q&A
Hour 2: Discussion: Prioritization and Collaboration (45 min)
  • Each agency has 5 minutes for opening remarks followed by committee discussion and Q&A
Open Discussion and Q&A with Committee (25 mins)
ADJOURN
Suggested Citation:"Appendix A: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Integrating Clinical Research into Epidemic Response: The Ebola Experience. Washington, DC: The National Academies Press. doi: 10.17226/24739.
×

Meeting 4: Washington, DC; June 13–15

Public Workshop of the Committee on Clinical Trials During the 2014–2015 Ebola Outbreak

Third Committee Meeting
June 13–15, 2016
Keck Center: 500 Fifth Street NW
Washington, DC 20001
Room 208

Day 1
Monday, June 13, 2016

Meeting Objectives:
  • Consider how to best align the missions and values of international stakeholders (governments, regulatory agencies, nongovernmental organizations, academic and industry researchers) to engender a rapid, robust, and sustained public health and research response.
  • Explore strategies and identify resources needed to effectively conduct clinical trials during an emergency without negatively impacting the public health and humanitarian response.
  • Discuss the ethical and scientific considerations in the design and implementation of clinical trials during the 2014–2015 Ebola outbreak; identify challenges and lessons learned, including issues around consent, community engagement, managing data, etc.
  • Explore the full economic impact of outbreaks, and discuss how sustainable funding for clinical research during public health outbreaks can be established and managed.
SESSION I – FOSTERING INTERNATIONAL COORDINATION AND COLLABORATION
Objectives:
  • Explore how nations with strong response capacity can work more effectively together under the leadership of international organizations like the WHO.
  • Consider how U.S. and other international institutions can cede the role of lead coordinating organization
Suggested Citation:"Appendix A: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Integrating Clinical Research into Epidemic Response: The Ebola Experience. Washington, DC: The National Academies Press. doi: 10.17226/24739.
×

for emergency response while still maintaining their autonomy.

8:30 a.m. Welcome by Committee Co-Chairs
  • Gerald Keusch, Committee Co-Chair, Boston University Schools of Medicine and Public Health
  • Keith McAdam, Committee Co-Chair, London School of Hygiene & Tropical Medicine
8:45 a.m. Opening Presentation: (15- to 20-min presentation followed by Q&A)
Lessons from Past Epidemics
  • Adel Mahmoud, Woodrow Wilson School of Public and International Affairs and Department of Molecular Biology, Princeton University
9:15 a.m. Moderator: Kathryn M. Edwards, Vanderbilt University School of Medicine
Panelists:

(90 min; 10-min opening remarks by each panelist, followed by discussion and Q&A)

  • Margaret A. Hamburg, Foreign Secretary, National Academy of Medicine
  • Inger K. Damon, Ebola Response Team Incident Commander, Centers for Disease Control and Prevention
10:45 a.m. BREAK
SESSION II – THE FEASIBILITY OF CLINICAL RESEARCH DURING HUMANITARIAN EMERGENCIES
Objectives:
  • Explore strategies and identify resources needed to effectively conduct clinical trials during an emergency without overburdening clinical care givers.
  • Consider the feasibility of using existing clinical care facilities established by NGOs/non-research-based organizations for research activities during an emergency.
  • Discuss approaches to bridge the divide between clinical care and medical research staff to find commonalities and improve the research response.
Suggested Citation:"Appendix A: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Integrating Clinical Research into Epidemic Response: The Ebola Experience. Washington, DC: The National Academies Press. doi: 10.17226/24739.
×
  • Consider how resources to support clinical trials in humanitarian emergencies might be prepositioned. Could there be a team of neutral ethics experts assembled to help low-resource countries review and approve trials when a myriad of requests are received?
11:00 a.m. Moderator: Janice Cooper, Liberia Mental Health initiative
Panelists:

(90 min; 10-min opening remarks by each panelist, followed by discussion and Q&A)

  • Nahid Bhadelia, Assistant Professor of Medicine, Director of Infection Control, National Emerging Infectious Disease Laboratories (NEIDL), Boston University
  • Peter Kilmarx, Deputy Director, Fogarty International Center, National Institutes of Health
  • Matthew Barnhart, Senior Science Advisor, Bureau for Global Health, USAID
12:30 p.m. LUNCH
SESSION III – THE ECONOMIC IMPLICATIONS OF OUTBREAKS
1:00 p.m. Objectives:
  • For low-resource countries with fragile economies, explore the full economic impact of outbreaks, including how low-income countries can best cope and how international assistance can be provided for recovery in the short term as well as the long term.
  • Discuss how sustainable funding for clinical research during public health outbreaks can be established and what an efficient mechanism for their allocation and use might be. How could the promising therapeutic and vaccine interventions be delivered, and who should pay?
  • Is there a reasonable source of sustainable funding for stockpiling interventions for emerging infectious diseases? How would such a fund be managed and by whom? What would be a workable mechanism for decision making about which products to store and when to release them?
Suggested Citation:"Appendix A: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Integrating Clinical Research into Epidemic Response: The Ebola Experience. Washington, DC: The National Academies Press. doi: 10.17226/24739.
×
Moderator: Gerald Keusch, Committee Co-Chair, Boston University Schools of Medicine and Public Health
Panelists:
(60 min; 10-min opening remarks by each panelist, followed by discussion and Q&A)
  • Ok Pannenborg, Retired Chief Health Advisor, World Bank
  • Mead Over, Senior Fellow, Center for Global Development
Suggested Citation:"Appendix A: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Integrating Clinical Research into Epidemic Response: The Ebola Experience. Washington, DC: The National Academies Press. doi: 10.17226/24739.
×

Day 2
Tuesday, June 14, 2016

SESSION IV – CLINICAL TRIALS CONDUCTED DURING THE 2014–2015 OUTBREAK

Objectives:
  • Discuss the considerations that were taken into account in the design of the trial (i.e., meeting scientific and ethical standards, health systems infrastructure, time to trial launch, public opinion, need of the affected population, etc.).
  • Discuss any alternative trial designs considered leading up to implementation of the trial; explore why particular designs were selected.
  • Explore the role of the trialist, if any, in selecting the interventions used in the EVD trials; discuss the considerations that go into advancing experimental compounds into clinical trials.
  • Discuss the trial results, where available, and explore the scientific and public health value in the data derived from each study. What, if anything, would you do differently next time to achieve greater gains from trials?
8:30 a.m. Welcome by Committee Co-Chairs
  • Gerald Keusch, Committee Co-Chair, Boston University Schools of Medicine and Public Health
  • Keith McAdam, Committee Co-Chair, London School of Hygiene & Tropical Medicine
8:45 a.m. Opening Presentation:

(15- to 20-min presentation followed by Q&A)

Looking Forward: Principles for Conducting Research during Emergencies, Lessons Learned through the Liberia–U.S. Joint Clinical Research Partnership
  • Elizabeth Higgs, Global Health Science Advisor, Division of Clinical Research, National Institute of Allergy and Infectious Disease (NIAID), National Institutes of Health (NIH)
Suggested Citation:"Appendix A: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Integrating Clinical Research into Epidemic Response: The Ebola Experience. Washington, DC: The National Academies Press. doi: 10.17226/24739.
×
9:15 a.m. Moderator: Jens Lundgren, University of Copenhagen
Panel 1: Vaccine Trials Conducted During the Ebola Outbreak
(90 min; 10-min opening remarks by each trial team followed by discussion and Q&A)
  • PREVAIL I
    • Jerome F. Pierson, Chief, Regulatory Compliance & Human Subjects Protection Branch, NIAID, NIH
    • James Neaton, Professor of Biostatistics, Adjunct Professor of Medicine, Distinguished International Professor, University of Minnesota
  • STRIVE:
    • Anne Schuchat, Principal Deputy Director, U.S. Centers for Disease Control and Prevention (CDC)
10:45 a.m. BREAK
11:00 a.m. Moderator: Roger J. Lewis, Harbor–UCLA Medical Center
Panel 2: Therapeutic Trials Conducted During the Ebola Outbreak
(90 min; 10-min opening remarks followed by discussion and Q&A)
  • PREVAIL II:
    • Richard T Davey, Senior Investigator, Laboratory of Immunoregulation, NIAID, NIH
    • John Beigel, Leidos Biomedical Research, Inc., in support of Clinical Research Section, LIR, NIAID, NIH
    • Mike Proschan, Mathematical Statistician, Biostatistics Research Branch, NIAID, NIH
    • Lori Dodd, Mathematical Statistician, Biostatistics Research Branch, NIAID, NIH
12:30 p.m. Closing Presentation

(15- to 20-min presentation followed by Q&A)

Fostering International Cooperation and Collaboration
  • Gray Handley, International Office Director at NIAID
1:00 p.m. ADJOURN Public Session Day 2
Suggested Citation:"Appendix A: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Integrating Clinical Research into Epidemic Response: The Ebola Experience. Washington, DC: The National Academies Press. doi: 10.17226/24739.
×

Day 3
Wednesday, June 15, 2016

SESSION V – DECISION MAKING DURING EMERGENCIES

Objectives:
  • Discuss the ethical imperatives present during an international humanitarian emergency and the role of local and international health officials, regulatory agencies, and research and clinical staff in determining an ethical course of action.
  • Explore how ethical and human rights considerations regarding clinical research can be assessed in the midst of an emerging outbreak.
  • Identify the appropriate role of international organizations and national/district-level health, research, and regulatory agencies in decision making.
8:30 a.m. Welcome by Committee Co-Chairs
  • Gerald Keusch, Committee Co-Chair, Boston University Schools of Medicine and Public Health
  • Keith McAdam, Committee Co-Chair, London School of Hygiene & Tropical Medicine
8:45 a.m. Opening Presentation:

(15- to 20-min presentation followed by Q&A)

Aligning Regulatory, Public Health, and Clinical Care Goals During an Epidemic Crisis
  • Jesse Goodman, Professor and Director, Center on Medical Product Access, Safety and Stewardship (COMPASS), Georgetown
9:15 a.m. Moderator: Charles D. Wells, Sanofi
Panelists:
(90 min; 10-min opening remarks by each panelist, followed by discussion and Q&A)
  • Ross Upshur, Canada Research Chair in Primary Care Research; Professor, Department of Family and Community Medicine and Dalla Lana School of Public Health, University of Toronto
Suggested Citation:"Appendix A: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Integrating Clinical Research into Epidemic Response: The Ebola Experience. Washington, DC: The National Academies Press. doi: 10.17226/24739.
×
  • Christine Grady, Chief, Clinical Center’s Department of Bioethics, National Institutes of Health Clinical Center
  • John David Pringle, Postdoctoral Fellow in Humanitarian Health Ethics, McGill University; Vice Chair, MSF Ethics Review Board, 2015
10:45 a.m. BREAK
SESSION VI – MANAGING GROUP DYNAMICS DURING CRISES
11:00 a.m. Objectives:
  • Examine how global institutions can respectfully prioritize and align the interests and expertise of organizations (including public health professionals, clinical care providers, and academic/medical research staff) to design and implement a coordinated course of action to achieve the greatest benefit, while respecting the opinions of local institutions and communities.
  • Provide examples of best practices used to address, prevent, and overcome disagreements within and between large institutions in order to reach agreeable compromises.
Moderator: Keith McAdam, Committee Co-Chair, Emeritus Professor of Clinical and Tropical Medicine, London School of Hygiene & Tropical Medicine
Panelists:
(90 min; 10-min opening remarks by each panelist followed by discussion and Q&A)
  • David Cooperrider, Fairmount Santrol–David L. Cooperrider Professor of Appreciative Inquiry at the Weatherhead School of Management, Case Western
  • Howard Gadlin, Retired Ombudsman and Director of the Center for Cooperative Resolution, NIH
SESSION VII – PUBLIC COMMENT
12:30 p.m. Open Public Comment (30 min)
  • Members of the public are invited to sign up to provide comments geared toward the session topic.
1:00 p.m. ADJOURN Public Session
Suggested Citation:"Appendix A: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Integrating Clinical Research into Epidemic Response: The Ebola Experience. Washington, DC: The National Academies Press. doi: 10.17226/24739.
×

Meeting 5: Monrovia, Liberia; August 14–17

Public Workshop of the Committee on Clinical Trials During the 2014–2015 Ebola Outbreak

Fourth Committee Meeting
August 15–16, 2016
Bella Casa Hotel
2nd Street Sinkor Tubman Blvd.
Monrovia, Liberia

Day 1
Monday, August 15, 2016

SETTING RESEARCH PRIORITIES DURING EMERGENCY INFECTIOUS DISEASE EVENTS

Day 1 Meeting Objective:
  • Explore lessons learned from the 2014–2015 Ebola outbreak to best prioritize, design and implement clinical research during public health emergencies.
8:30 a.m. Meeting Registration
9:00 a.m. Welcome by Committee Co-Chairs
  • Gerald Keusch, Committee Co-Chair, Boston University Schools of Medicine and Public Health
  • Keith McAdam, Committee Co-Chair, London School of Hygiene & Tropical Medicine
Welcome and Perspectives from the Ministries of Health
  • Discuss the top lessons learned from the Ebola outbreak. How can research best be incorporated into national response efforts in the event of future outbreaks?
Co-Moderators: Janice Cooper, Carter Center Liberia M. Bailor Barrie, Wellbody Alliance
Speakers (10-min prepared remarks each, followed by Q&A):
  • Hon. Bernice Dahn, Minister of Health and Social Welfare, Ministry of Health and Social Welfare of the Republic of Liberia
Suggested Citation:"Appendix A: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Integrating Clinical Research into Epidemic Response: The Ebola Experience. Washington, DC: The National Academies Press. doi: 10.17226/24739.
×
  • Hon. Zulianatu Cooper, Deputy Minister of Health and Sanitation II, Ministry of Health and Sanitation of the Republic of Sierra Leone
10:00 a.m. BREAK
10:15 a.m. Panel 1: Prioritizing Research in Outbreak Response
  • Describe national capacity over time to respond to the outbreak. What were the key challenges and lessons learned?
  • Discuss the process by which research proposals were prioritized.
  • Discuss how the numerous and varied institutional pressures influenced decision-making priorities.
  • Consider how to facilitate the incorporation of clinical trials in the public health and care response during future emergency infectious disease events.
Co-Moderators: Janice Cooper, Carter Center Liberia M. Bailor Barrie, Wellbody Alliance
Panelists (10-min prepared remarks each):
  • Tolbert Nyenswah, Legal and Senior Public Health Specialist, Deputy Minister Health for Disease Surveillance and Epidemic Control, Liberia
  • Alie Wurie, Case Management Lead, National Emergency Response, Ministry of Health and Sanitation, Republic of Sierra Leone
  • Alpha Mahmoud Barry, Public Health Specialist, Researcher, University of Gammal, Conakry, Guinea
Respondents (5 min each, reaction to panelists):
  • Moses Massaquoi, National Case Manager, Ebola Response, Ministry of Health/IMS; Country Director, Clinton Health Access Initiative (CHAI); Chair, Sub-Regional Consortium on Ebola Virus Vaccine and Therapeutic Trials in Guinea, Liberia, and Sierra Leone
  • Vuyu Kanda Golakai, Professor, College of Health and Life Sciences, University of Liberia
Moderated Discussion with Committee and Participants
11:45 a.m. LUNCH
Suggested Citation:"Appendix A: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Integrating Clinical Research into Epidemic Response: The Ebola Experience. Washington, DC: The National Academies Press. doi: 10.17226/24739.
×
12:45 p.m. Panel 2: Perspectives from the Research and Training Community
  • Discuss lessons learned from the international research partnerships during the Ebola outbreak. How would you apply those lessons to future research collaborations?
  • Examine the research capacity that was acquired by the national researchers as a result of the international research partnerships.
  • Discuss the process by which research proposals for therapeutic and vaccine candidates were prioritized for clinical trials. How can this process be improved?
  • Describe challenges with designing and implementing scientifically and ethically robust vaccine and therapeutic trials during the Ebola outbreak.
  • Explore new ideas and innovative approaches for accelerating future clinical trials in emergency contexts; identify pragmatic methods for building community support, speeding data collection, and assessing the safety, efficacy, and effectiveness of therapeutics and vaccines.
Moderator: Fred Wabwire Mangen, Makerere University–Uganda
Panelists (10-min prepared remarks each):
  • Mandy Kader Konde, Professor and Chair, Department of Public Health, University of Conakry; Chairman Guinea Ebola Research Commission; Executive Director, Center of Research on Diseases (CEFORPAG) – Guinea Ring Vaccine
  • Mohamed Samai, PI STRIVE Vaccine Study; Acting Provost of College of Medicine and Allied Health Sciences (COMAHS); Deputy Director for Research, Ministry of Health and Sanitation, Freetown, Sierra Leone – STRIVE Vaccine Trial
  • Stephen B. Kennedy, Co-Principal Investigator, PREVAIL & Coordinator, EVD Research, Incident Management System (IMS), Liberia – PREVAIL Trials
Respondents (5 min each, reaction to panelists):
  • Abdoul Habib Beavogui, Director, National Center for Training and Research in Rural Health (CNFRSR) “Jean SENECAL” of Maferinyah, Republic of Guinea – JIKI (Favipiravir)
Suggested Citation:"Appendix A: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Integrating Clinical Research into Epidemic Response: The Ebola Experience. Washington, DC: The National Academies Press. doi: 10.17226/24739.
×
  • Bartholomew Wilson, Social Mobilization, Communication and Community Engagement (SMC) Lead of the Partnership for Research on Ebola Virus in Liberia – PREVAIL Trials
Moderated Discussion with Committee and Participants
2:45 p.m. BREAK
3:00 p.m. Panel 3: Perspectives from Regulatory Authorities
  • Describe the mandate of your agency and its role in research, development, and procurement of therapeutic and vaccine products.
  • Discuss the lessons learned and practical challenges encountered during the Ebola outbreak.
  • Identify key capacity-building needs to improve local regulatory capabilities; consider the availability of resources and regulatory protocols to enable the rapid review of investigational medical products.
Moderator: Susan Ellenberg, University of Pennsylvania
Panelists (10-min prepared remarks each):
  • Beno Yakubu Nyam, Chief Regulatory Officer, Clinical Trial Unit, Drug Evaluation and Research Directorate, National Agency for Food and Drug Administration and Control (NAFDAC)
  • Wiltshire C. N. Johnson, Registrar, Pharmacy Board of Sierra Leone
  • David Sumo, Managing Director, Liberian Medicines Health Products Regulatory Authority (LMHRA)
Respondent (5 min, reaction to panelists):
  • Onome Thomas Abiri, Head of Pharmacovigilance and Clinical Trial Department, Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation
Moderated Discussion with Committee and Participants
4:00 p.m. Panel 4: Perspectives from the Ethics Review Board (ERB)
  • Describe the procedures for review of research proposals during the Ebola outbreak. Discuss lessons learned,
Suggested Citation:"Appendix A: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Integrating Clinical Research into Epidemic Response: The Ebola Experience. Washington, DC: The National Academies Press. doi: 10.17226/24739.
×
  • practical challenges encountered, and identify approaches for more efficient reviews in the future.

  • Discuss the role of the ERB in helping shape the clinical trial design decisions and in negotiating terms of the trial.
  • In the event of a future outbreak, discuss any best practices to achieve community understanding of key trial design components (such as randomization) if they are determined to be required for valid trial results.
Moderator: Olayemi Omotade, University of Ibadan
Panelists (10-min prepared remarks each):
  • Hector Morgan, Professor, Department of Microbiology, College of Medicine and Allied Health Sciences, University of Sierra Leone; Director, Research Ethics Committee, Freetown, Sierra Leone
  • Fatorma K. Bolay, Director, Liberia Institute of Biomedical Research (LIBR); Chairperson, Liberia Institute for Biomedical Research Ethics Committee
  • Nnah Djenab Sylla, Secretary General, National Ethics Committee on Health Research, Guinea
Respondents (5 min each, reaction to panelists):
  • Gloria Mason, Coordinator, National Research Ethics Board (NREB), Liberia
  • Tumani Corrah, Director (MRC UK) Africa Research Development, Director Africa Research Excellence Fund; Emeritus Director, MRC Unit, The Gambia
Moderated Discussion with Committee and Participants
5:30 p.m. ADJOURN
6:15 p.m. Wine Reception and Dinner at the Bella Casa Restaurant “Suave”
  • Hosted by the National Academy of Medicine’s Independent Commission for a Global Health Risk Framework
  • Remarks by Dr. Oyewale Tomori, President, Nigerian Academy of Science
Suggested Citation:"Appendix A: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Integrating Clinical Research into Epidemic Response: The Ebola Experience. Washington, DC: The National Academies Press. doi: 10.17226/24739.
×

Day 2
Tuesday, August 16, 2016

ENGAGING COMMUNITIES IN RESEARCH DESIGN AND IMPLEMENTATION DURING OUTBREAKS

Day 2 Meeting Objective:
  • Explore lessons learned from the 2014–2015 Ebola outbreak to best engage communities in the design and implementation of clinical research during future outbreaks.
  • Discuss opportunities for community involvement in planning activities to better prepare and build local research capacity for future epidemics.
8:30 a.m. Meeting Registration
9:00 a.m. Welcome by Committee Co-Chairs
  • Gerald Keusch, Committee Co-Chair, Boston University Schools of Medicine and Public Health
  • Keith McAdam, Committee Co-Chair, London School of Hygiene & Tropical Medicine
Panel 5: Community Mobilizers’ Perspectives
  • Explore challenges and lessons learned during the Ebola outbreak to overcome fear, rumors, and stigma in the community; consider key groups to engage to ensure effective and far-reaching community engagement.
  • Identify best practices for community engagement during a future outbreak and explore methods to gauge individual and community comprehension, acceptance, and adherence to key messages, such as those conveyed during the communication of vaccine or therapeutic trials.
Moderator: Charles Wells, Sanofi
Panelists (10-min prepared remarks each):
  • Reverend John Barclay Sumo, Director, National Health Promotion Division; Chair, Social Mobilization Pillar, Ministry of Health
  • Mohammad Bailor Jalloh, Chief Executive Officer, Focus1000
Suggested Citation:"Appendix A: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Integrating Clinical Research into Epidemic Response: The Ebola Experience. Washington, DC: The National Academies Press. doi: 10.17226/24739.
×
  • Alpha Mahmoud Barry, Public Health Specialist, Researcher, University of Gammal, Conakry, Guinea
Respondents (5 min each, reaction to panelists):
  • Musa Sangarie, Program Manager, BBC Media Action Sierra Leone
  • Luke Bawo, Coordinator for Health Management Information Systems (HMIS), Research and Monitoring and Evaluation (M&E), National Ministry of Health in Liberia
Moderated Discussion with Committee and Participants
10:30 a.m. BREAK
10:45 a.m. Panel 6: Patient and Clinician Perspectives
  • Discuss your experiences during the Ebola outbreak; consider the clinical care provided in Ebola treatment units and explore lessons learned to overcome fear, rumors, and stigma in the community.
  • Discuss the role of research during the Ebola outbreak and explore how research should be done during a future outbreak, both during the crisis and once the crisis has passed. How can researchers best address survivors’ concerns?
  • In the event of a future outbreak, examine your community’s understanding of and expectations from clinical care and clinical trials.
Moderator: David Peters, Johns Hopkins University
Panelists (10-min prepared remarks each):
  • Achille Diona Guemou, Chairman, Ebola Association Network; Physician with Association pour la Réinsertion des Personnes Guéries et Affectées d’Ebola en Guinée (Association for Rehabilitation of Persons Affected and Cured of Ebola in Guinea)
  • Abdul Karim Bah, Chief Executive Officer, Sierra Leone Association of Ebola Survivors (S.L.A E.S)
  • Patrick Faley, Survivor’s Consultant – PREVAIL Research Program; Former President, National Ebola Survivors Network Liberia
Suggested Citation:"Appendix A: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Integrating Clinical Research into Epidemic Response: The Ebola Experience. Washington, DC: The National Academies Press. doi: 10.17226/24739.
×
Moderated Discussion with Committee and Participants
12:15 p.m. LUNCH
1:15 p.m. Panel 7: Perspectives from Civil Society
  • Discuss lessons learned and greatest challenges during the Ebola outbreak, and explore the engagement of civil society in the Ebola clinical trials.
  • In the event of a future outbreak, discuss how civil society can best be involved in outbreak response and clinical research.
Moderator: Abdel G. Babiker, Medical Research Council Clinical Trials Unit, UCL
Panelists (10-min prepared remarks each):
  • Ambassador Juli Endee, Culture Ambassador of the Republic of Liberia, traditional Queen, UNICEF Goodwill Ambassador for Children in Liberia and Executive Director of the Liberia Crusaders for Peace
  • Shiekh Ahmad Tejan Sillah, United Nations Goodwill Ambassador, Chief Imam of the Freetown Central Mosque, Founding Member of the Inter-Religious Council of Sierra Leone
  • Abdoulaye Touré, Associate Professor of Epidemiology, Conakry University
  • Chief Zanzan Kawa, Chairman of the Council of Chiefs, Liberia
Moderated Discussion with Committee and Participants
2:30 p.m. BREAK
2:45 p.m. Breakout Groups with Facilitated Discussion
  • Further explore strategies to engage communities in advance of and during outbreaks so that future research is designed to meet the communities’ needs.
3:45 p.m. Reconvene in Plenary Session
  • Recap breakout group discussions.
Suggested Citation:"Appendix A: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Integrating Clinical Research into Epidemic Response: The Ebola Experience. Washington, DC: The National Academies Press. doi: 10.17226/24739.
×
4:15 p.m. Panel 8: Building Local Research Capacity to Meet Community Needs
  • Explore planning activities during the inter-epidemic period to better prepare for and improve the execution of clinical trials during future infectious disease public health emergencies.
  • Identify collaborative opportunities to achieve long-term ethical and scientific gains from clinical trials conducted during emerging infectious disease events.
Panelists and Group Leads (10 minutes prepared remarks followed by breakout groups with facilitated discussion):
Moderator: Roger Lewis, Harbor–UCLA Medical Center
  • Oyewale Tomori, President, Nigerian Academy of Science
  • Mosoka Fallah, Ebola Emergency-Response Program Manager, Action Contre la Faim (ACF) – Liberia
  • Tumani Corrah, Director (MRC UK) Africa Research Development, Director Africa Research Excellence Fund; Emeritus Director, MRC Unit, The Gambia
Moderated Discussion with Committee and Participants
5:15 p.m. Open Comment Period and Workshop Wrap-Up
  • Members of the public are invited provide comments geared toward the topics covered in the panel discussions over the course of the 2 days.
5:30 p.m. ADJOURN
Suggested Citation:"Appendix A: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Integrating Clinical Research into Epidemic Response: The Ebola Experience. Washington, DC: The National Academies Press. doi: 10.17226/24739.
×

Day 3
Wednesday, August 17, 2016

LIBERIA SITE VISITS

1:00 p.m. Committee Liberia site visits
  • University of Liberia, A.M. Dogliotti College of Medicine
  • John F. Kennedy Medical Center
  • ELWA-2 (Eternal Love Winning Africa) Ebola Treatment Unit
  • Liberian Institute for Biomedical Research (LIBR)
Suggested Citation:"Appendix A: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Integrating Clinical Research into Epidemic Response: The Ebola Experience. Washington, DC: The National Academies Press. doi: 10.17226/24739.
×

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Suggested Citation:"Appendix A: Study Approach and Methods." National Academies of Sciences, Engineering, and Medicine. 2017. Integrating Clinical Research into Epidemic Response: The Ebola Experience. Washington, DC: The National Academies Press. doi: 10.17226/24739.
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Next: Appendix B: Clinical Trial Designs »
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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.

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