Integrating Clinical Research into Epidemic Response The Ebola Experience (2017) / Chapter Skim
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7 Facilitating International Coordination and Collaboration
7 Facilitating International Coordination and Collaboration
Pages 223-250
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From page 223... ...
The trial teams should be praised for overcoming the complex and intertwined logistical obstacles encountered while trying to design and implement trials in West Africa in the midst of a rapidly spreading and highly dangerous contagious disease epidemic. The limited health care, public health, and health research infrastructure; the bureaucracy; fear, rumors, and lack of trust; and supply chain hurdles were just some of the barriers that had to be addressed and overcome.
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. The committee concurs with the conclusion by the UK House of Commons Science and Technology Committee's report Science in Emergencies: UK Lessons from Ebola: "The failure to conduct therapeutic trials earlier in the outbreak was a serious missed opportunity that will not only have cost lives in this epidemic but will impact our ability to respond to similar events in the future" (House of Commons Science and Technology Committee, 2016, p.
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The team's mission is to support national health systems to rapidly investigate and respond to disease outbreaks, and the team includes epidemiologists, microbiologists, experts in infectious disease control, social scientists, and experts in clinical research, thereby ensuring that research considerations including clinical research are included in response planning from the very beginning (PHE, 2016)
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226 EPIDEMIC PEAK Perform independent ethics reviews Consult with regulators TRIAL LAUNCH Negotiate contracts Prioritize vaccines and therapies and select trial designs Integrate research efforts into response; facilitate stakeholder coordination Engage communities, establish mutual trust Collect and share patient information; establish standards of care PHEIC IDENTIFIED RESPONSE BEGINS TOTAL NUMBER of CASES OUTBREAK DECLARED 1ST CONFIRMED CASE 0,0 TIMELINE of an EPIDEMIC INTER-EPIDEMIC planning ACTIVITIES LAUNCHING CLINICAL TRIALS IN AN EPIDEMIC A Timeline of Critical Components * PHEIC (Public Health Emergency of International Concern)
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(5) As investigational agents and trial designs are being prioritized the Rapid Research Response Workgroup (see Recommendation 7b)
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31) If not for these initial investments in research and early preclinical development, it is very unlikely that any products would have been any 2 G-FINDER is a uniquely informative data source, providing policy makers, funders, researchers, and industry with objective, previously unavailable information on the state of investment, trends, and patterns • in 35 neglected diseases; • across 142 product areas for these diseases including drugs, vaccines, diagnostics, microbicides and vector control products; and • in platform technologies (e.g., adjuvants, delivery technologies, diagnostic platforms)
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-- a dismal prospect if the global community hopes to be prepared in the event of a future outbreak. The severity and rapid escalation of transmission of Ebola in West Africa during 2014 motivated the initiation of clinical trials, as the situation was so desperate and the epidemic would be the only opportunity to evaluate efficacy in humans.
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Achieving this outcome is critical not only for Ebola preparedness, but also for proof of concept that vaccines to protect against other neglected or emerging infectious diseases can be successfully developed in the future" (Ebola Vaccine Team B, 2017)
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However, the historical problem remains: how to keep the focus of global leadership on the threat of future pandemic outbreaks and on supporting the vision of innovators in R&D, when there are so many different threats, even just for global health. Operational Considerations Conducting clinical trials requires addressing a litany of bureaucratic, legal, and ethical issues in addition to the scientific considerations.
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If emergency and epidemic response plans include ways to address these operational and logistical challenges, clinical researchers can overcome these hurdles more quickly and begin to evaluate potential agents to stop the outbreak more expeditiously than before, particularly if much of the general clinical trial planning work is done during the inter-epidemic period. Conclusion 7-1 Research and development is a complex and lengthy process that cannot be compressed into the course of a rapidly pro gressing outbreak.
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. In its account of the Ebola outbreak, the UK House of Commons Science and Technology Committee (2016)
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What we handled well, what did we not handle well, what should we do differently in the future, paying attention to the emergence of group norms that may be somewhat counter-productive."6 It would be valuable and advantageous for the principal stakeholders, during the inter-epidemic period, to engage in early planning that is focused on the development of a list of priority pathogens to target for R&D, the creation of generic protocols, to establish memoranda of understanding, and to discuss material transfer agreements and other administrative details that would suddenly become high priority during an emerging infectious disease outbreak such as a central data repository. For example, in the case of protocols, the coalition of stakeholders discussed below would seek consensus about specific trial design issues for different priority pathogens, such as the population to be studied, the trial's primary endpoint including the potential role of surrogate measures, the use of individual versus cluster randomization, the feasibility of blinding the randomization, and approaches to improve efficiency by simultaneously evaluating complementary interventions such as through the use of factorial designs.
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Events on a global scale generally require a global solution, which in turn requires international coordination and cooperation. There are no events for which this is more applicable than emerging infectious diseases outbreaks, for even when initially localized within a country's borders such outbreaks can quickly become global.
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Each aspect of conducting research during an epidemic -- following a research agenda, prioritizing agents for study, choosing trial designs, engaging with the community -- can be best accomplished through a coordinated international effort. This committee recommends that upon the emergence of an epidemic, the ICS designate a rapid research response workgroup (R3W)
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First, in order for it to be available to serve at the outset of an epidemic, the ICS must be organized in the inter-epidemic period and include all relevant stakeholders. This list is long and should include, for example, the WHO, research organizations in regions of the world where outbreaks are likely to occur, regional scientific groups and academic centers, large research organizations from developed countries with experience in global health and emerging infectious diseases
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238 FIGURE 7-2 A visual representation of how the international coalition of stakeholders and rapid research response workgroup relate to one another, as suggested in Recommendations 7a and 7b. NOTE: NGO = nongovernmental organization; R&D = research and development; WHO = World Health Organization.
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, REACTing: REsearch and ACTion targeting emerging infectious diseases) , as well as pan-African, Asian, and South American public health and research organizations.
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the Coalition for Epidemic Preparedness Innovations. World Health Organization R&D for emerging infectious diseases is a vast challenge, and it requires depth in basic, translational, and clinical research expertise; focus; and a big budget.
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It is worth considering whether the WHO ought to be the responsible party for all of the above tasks. Without doubt, the WHO is an essential part of the international response to outbreaks of emerging infectious diseases.
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multilateral and multi-sectoral approach to strengthen both the global capacity and nations' capacity to prevent, detect, and respond to infectious diseases threats whether naturally oc curring, deliberate, or accidental -- capacity that once established would mitigate the devastating effects of Ebola, MERS, other highly pathogenic infectious diseases, and bioterrorism events." (GHSA, 2016b) GHSA was launched in February 2014 (see Box 7-1, Global Health Security Agenda for GHSA's major commitments at the time of its launch)
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(USAID, 2016) While GHSA is relevant to the goal of responding to emerging infectious diseases threats through international cooperation and collaborations, it is not an R&D program for therapeutics and vaccines.
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The committee looks forward to GHSA addressing this very important agenda, but it does not consider GHSA the right structure to entrust with the R&D and clinical research agenda; furthermore, GHSA is driven by one country, and its priorities and commitments may change with changes in national leadership. Coalition for Epidemic Preparedness Innovations There are other new concepts for international coordination and cooperation more specifically targeted to R&D, including vital clinical research, for emerging epidemic diseases.
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. With the global recognition and significant financial and scientific resources of the founding partners, CEPI is already taking steps to lead international coordination and cooperation in vaccine development for emerging infectious diseases.
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EMBEDDING RESEARCH INTO RESPONSE There will be a need to connect the proposed ICS and R3W with other international response agencies during an epidemic and with the leadership of national governments affected by an outbreak from its very onset in order to ensure that the affected population has a partnership position in the response. Together, the response and research agencies and organizations can share the responsibility and allocate resources efficiently and effectively so that the goals of the response and research activities are clear and agreed upon, and that community engagement and communication strategies are aligned.
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As discussed in greater detail in the preceding chapters, clinical trials require a diverse range of expertise, from scientific and medical experts to those who are adept at law, ethics, and community engagement. It is not possible to consider how to improve the speed and efficiency of clinical research on an emerging infectious disease without reflecting on the need to determine that an outbreak is beginning or that a new or neglected agent is emerging; the first step in the chain is to have effective and sustainable surveillance in place within countries, connected to a global community with expertise and resources to deploy once the need is identified and a response is triggered.
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U.S. commitment to the global health security agenda: Toward a world safe & secure from infectious disease threats.
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2016. Research investments in global health: A systematic analysis of UK infectious disease research funding and global health metrics, 1997–2013.
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2017. New vaccines against epidemic infectious diseases.
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