Integrating Clinical Research into Epidemic Response The Ebola Experience (2017) / Chapter Skim
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Appendix A: Study Approach and Methods
Appendix A: Study Approach and Methods
Pages 251-286
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From page 251... ...
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.
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From page 252... ...
IDENTIFYING WEST AFRICAN EXPERTS FOR A LOCAL PERSPECTIVE The committee held a 2-day public workshop in August 2016 in M onrovia, 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)
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From page 253... ...
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*
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From page 254... ...
") Anthropology Search Parameters: • Date range: all years; • International, English only Databases: • PubMed • Anthropology Plus • AnthroSource • ClinicalTrials.gov 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
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From page 255... ...
OPEN SESSION 4:00 p.m. Opening Remarks to Public Audience • erald Keusch, Committee Co-Chair, Professor of G Medicine and International Health, Boston University Schools of Medicine and Public Health • eith McAdam, Committee Co-Chair, Emeritus K Professor of Clinical and Tropical Medicine, London School of Hygiene & Tropical Medicine 4:05 p.m.
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From page 256... ...
Opening Remarks to Public Audience • erald Keusch, Committee Co-Chair, Professor of G Medicine and International Health, Boston University Schools of Medicine and Public Health • eith McAdam, Committee Co-Chair, Emeritus K 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)
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From page 257... ...
10:00 a.m. ADJOURN Open Session CLOSED COMMITTEE SESSION 10:00 a.m.
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• 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)
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From page 259... ...
• 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 • eidi Larson, Senior Lecturer, London School of Hygiene H & 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)
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From page 260... ...
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 • na Maria Henao-Restrepo, Medical Officer at the A Initiative for Vaccine Research (IVR)
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From page 261... ...
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.
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From page 262... ...
• the context of a public health emergency in a In 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]
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From page 263... ...
10:00 a.m. Objectives: • Explore how the ethical principles for clinical trial conduct are applied in a low-resource outbreak setting, consider: o Scientific validity and health value of the study o Fair subject selection and subject respect o Risk–benefit ratio; equipoise o 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.
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From page 264... ...
• 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 • arguerite Koutsoukos, Director Ebola and HIV M programs, GlaxoSmithKline (GSK)
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From page 265... ...
• 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.
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From page 266... ...
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.
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• 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)
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From page 268... ...
• 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.
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From page 269... ...
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.
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From page 270... ...
• ahid Bhadelia, Assistant Professor of Medicine, N Director of Infection Control, National Emerging Infectious Disease Laboratories (NEIDL) , Boston University • eter Kilmarx, Deputy Director, Fogarty International P Center, National Institutes of Health • atthew Barnhart, Senior Science Advisor, Bureau for M Global Health, USAID 12:30 p.m.
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From page 271... ...
APPENDIX A 271 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) • k Pannenborg, Retired Chief Health Advisor, World O Bank • ead Over, Senior Fellow, Center for Global M Development
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From page 272... ...
8:30 a.m. Welcome by Committee Co-Chairs • erald Keusch, Committee Co-Chair, Boston University G Schools of Medicine and Public Health • eith McAdam, Committee Co-Chair, London School of K Hygiene & Tropical Medicine 8:45 a.m.
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From page 273... ...
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: o ichard T Davey, Senior Investigator, Laboratory of R Immunoregulation, NIAID, NIH o John Beigel, Leidos Biomedical Research, Inc., in support of Clinical Research Section, LIR, NIAID, NIH o ike Proschan, Mathematical Statistician, Biostatistics M Research Branch, NIAID, NIH o ori Dodd, Mathematical Statistician, Biostatistics L Research Branch, NIAID, NIH 12:30 p.m.
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From page 274... ...
8:30 a.m. Welcome by Committee Co-Chairs • erald Keusch, Committee Co-Chair, Boston University G Schools of Medicine and Public Health • eith McAdam, Committee Co-Chair, London School of K Hygiene & Tropical Medicine 8:45 a.m.
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From page 275... ...
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) • avid Cooperrider, Fairmount Santrol–David L
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From page 276... ...
Welcome by Committee Co-Chairs • erald Keusch, Committee Co-Chair, Boston University G Schools of Medicine and Public Health • eith McAdam, Committee Co-Chair, London School of K 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?
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• 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.
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• 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.
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From page 279... ...
Respondent (5 min, reaction to panelists) : • nome Thomas Abiri, Head of Pharmacovigilance and O Clinical Trial Department, Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation Moderated Discussion with Committee and Participants 4:00 p.m.
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From page 280... ...
Moderator: Olayemi Omotade, University of Ibadan Panelists (10-min prepared remarks each) : • ector Morgan, Professor, Department of Microbiology, H College of Medicine and Allied Health Sciences, University of Sierra Leone; Director, Research Ethics Committee, Freetown, Sierra Leone • atorma K
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From page 281... ...
Welcome by Committee Co-Chairs • erald Keusch, Committee Co-Chair, Boston University G Schools of Medicine and Public Health • eith McAdam, Committee Co-Chair, London School of K 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.
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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.
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From page 283... ...
Babiker, Medical Research Council Clinical Trials Unit, UCL Panelists (10-min prepared remarks each) : • mbassador Juli Endee, Culture Ambassador of the A Republic of Liberia, traditional Queen, UNICEF Goodwill Ambassador for Children in Liberia and Executive Director of the Liberia Crusaders for Peace • hiekh Ahmad Tejan Sillah, United Nations Goodwill S Ambassador, Chief Imam of the Freetown Central Mosque, Founding Member of the Inter-Religious Council of Sierra Leone • bdoulaye Touré, Associate Professor of Epidemiology, A Conakry University • hief Zanzan Kawa, Chairman of the Council of Chiefs, C Liberia Moderated Discussion with Committee and Participants 2:30 p.m.
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• 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)
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From page 285... ...
Ebola Treatment Unit • Liberian Institute for Biomedical Research (LIBR)
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