Integrating Clinical Research into Epidemic Response The Ebola Experience (2017) / Chapter Skim
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1 Introduction
1 Introduction
Pages 19-36
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. There was, nonetheless, some steady progress, including nonhuman primate challenge studies on investigational therapeutic agents and vaccines and also some very limited human Phase 1 studies of vaccine candidates at the beginning of 2014 (Gebre et al., 2014)
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And no one knew when, where, or whether this situation would present itself -- until the epidemic of 2014–2015. Conducting clinical research can often seem secondary to addressing the immediate health needs of patients, if not a distraction and unnecessary impediment to public health control activities and patient care in the midst of a public health emergency.
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. The 2014–2015 Ebola epidemic was different from all previous Ebola outbreaks -- it was unpredictable and fast moving, crossed borders, affected large numbers of people, was highly deadly, and was exacerbated by the lack of local experience, resources, infrastructure, and the limited number of experienced researchers (Heymann and Wertheimer, 2014)
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. BOX 1-2 Statement of Task An ad hoc committee of the National Academies of Science, Engineering, and Medicine will review and conduct an analysis of the clinical trials conducted during the 2014–2015 Ebola virus disease outbreak in West Africa.
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o ompare pragmatic, ethical, and scientific practices and consider C ations made in the context of each Ebola clinical trial against existing best practices to identify additional best practices and make recom mendations on opportunities for improving future clinical research conducted during public health emergencies. • Make recommendations for how, in the context of an international emerg ing or reemerging infectious disease event, clinical trials can best be prioritized and conducted to (1)
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The committee also solicited and considered written statements from stakeholders and members of the public, as well as soliciting information regarding the clinical trials conducted from responsible clinical trial teams. Furthermore, the committee conducted an extensive literature review on relevant topics.
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. The Ebola epidemic in Guinea, Liberia, and Sierra Leone exposed and strained those countries' already fragile health care and public health systems, and the situation quickly deteriorated: the shortage of staff was exacerbated when workers became infected or, in some instances, refused TABLE 1-1 Data Depicting the Deficit of Medical Doctors and Hospital Beds in the Ebola-Affected Countries at the Time of the Ebola Outbreak in Comparison to Higher-Income Countries Country Medical Doctor Density Hospital Bed Density Guinea 0.1 physicians/1,000 population 0.3 beds/1,000 population (2005)
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In addition to the lack of facilities, staff, and equipment, the response to the Ebola outbreak was made more difficult because of such issues as stigma, fear, rumors, traditional practices, mistrust of authorities and foreign response workers, and mistakes made in engaging communities and community leaders. Stigma took on different forms in different communities, but it complicated the response efforts in all three countries.
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. The WHO country office in Guinea classified the outbreak as a grade 2 emergency: "a single or multiple country event with moderate public health consequences that requires a moderate WHO country office response and/or moderate international
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. Within 3 days, from May 27 to May 30, the cases of Ebola reported in Sierra Leone tripled from 16 to 50 (Boston Children's Hospital and Harvard Medical School, 2016)
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, and it was not until August 8 that WHO declared the Ebola outbreak a public health emergency of international concern (PHEIC)
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. The WHO coordinated outbreak response efforts through the Global Outbreak Alert and Response Network, which "deployed a multidisciplinary workforce of 895 experts in the current Ebola outbreak response operation in West Africa, including doctors, nurses, infection control specialists, logisticians, laboratory specialists; communication, anthropology and social mobilization experts, emergency management and public health professionals among others" (WHO, 2016b)
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Conducting the trials took immense effort, from selecting investigational medicinal products to identifying trial sites and setting up appropriate infrastructure to implement trials in the midst of a public health emergency. The success of these groups in launching clinical trials on a compressed time frame, in countries that were unfamiliar with clinical research, and for products that had largely never before been tested in humans, was groundbreaking.
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Chapter 5, Strengthening Capacity for Research and Response, examines the underlying health systems in West Africa and how a lack of clinical and research capacity influenced clinical research and epidemic response, examines logistical considerations that impacted the conduct of trials, and makes recommendations on how to strengthen capacity to be better prepared for the next epidemic. Chapter 6, Engaging Communities in Research and Response, discusses the social and community context that surrounded the Ebola outbreak and how this influenced clinical trials and explores best practices for community engagement in the event of a future public health emergency.
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From page 33... ...
2017. The politics of fear: Médecins Sans Frontières and the West African Ebola epidemic.
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2016. Conducting clinical trials in outbreak settings: Points to consider.
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2014d. Ebola virus disease, West Africa -- Update.
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