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EBOVAC-Salone: Lessons learned from implementing an Ebola vaccine trial in an Ebola-affected country.

ABSTRACT: Background/aims During the 2014-2016 West African Ebola epidemic, clinical trials were fast-tracked in order to identify prophylactic vaccines and experimental treatments that might be useful in preventing or treating Ebola. These trials included the ongoing EBOVAC-Salone study, which was established and implemented in Sierra Leone to assess the safety and immunogenicity of the Ad26.ZEBOV/MVA-BN-Filo prime-boost Ebola vaccine regimen. Methods This article describes the experiences of the EBOVAC-Salone research team in setting up and implementing the trial, and provides recommendations for research teams aiming to conduct clinical trials in future outbreak situations. Results Establishing a clinical trial during an outbreak brought some unique challenges, including those related to trial design and the regulatory environment, operational issues, and community engagement. The situation was further complicated by the weak infrastructure and limited experience of clinical trials in Sierra Leone. However, operating in an outbreak context also brought some benefits to the research team, including strong stakeholder support. The EBOVAC-Salone study recruited participants both during and after the outbreak, leading to additional challenges to trial implementation during the post-outbreak transition. Conclusion Many lessons have been learned about setting up and implementing a clinical trial during a devastating Ebola epidemic, and some of the experiences of the EBOVAC-Salone team were mirrored by those of other researchers operating in the region. Common to several of these research groups is a recommendation that research should be more closely incorporated into outbreak response planning, which could expedite the establishment of timely and appropriate research projects. We recommend that the lessons learned by researchers during the West African Ebola epidemic are built into programmes and strategies to improve the responses to future epidemics, wherever they occur.

SUBMITTER: Mooney T

PROVIDER: S-EPMC6136072 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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EBOVAC-Salone: Lessons learned from implementing an Ebola vaccine trial in an Ebola-affected country.

Mooney Thomas T Smout Elizabeth E Leigh Bailah B Greenwood Brian B Enria Luisa L Ishola David D Manno Daniela D Samai Mohamed M Douoguih Macaya M Watson-Jones Deborah D

Clinical trials (London, England) 20180612 5

Background/aims During the 2014-2016 West African Ebola epidemic, clinical trials were fast-tracked in order to identify prophylactic vaccines and experimental treatments that might be useful in preventing or treating Ebola. These trials included the ongoing EBOVAC-Salone study, which was established and implemented in Sierra Leone to assess the safety and immunogenicity of the Ad26.ZEBOV/MVA-BN-Filo prime-boost Ebola vaccine regimen. Methods This article describes the experiences of the EBOVAC- ...[more]

PMID: 29895178

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Project description:BackgroundType 2 diabetes mellitus is preventable through lifestyle intervention. Diabetes prevention programmes (DPPs) aim to deliver prevention-based behaviour change interventions to reduce incidence. Such programmes vary from usual primary care in terms of where, how, and by whom they are delivered. Implementation is therefore likely to face new commissioning, incentive and delivery challenges. We report on the implementation of a national DPP in NHS England, and identify lessons learned in addressing the implementation challenges.MethodsIn 2017/18, we conducted 20 semi-structured telephone interviews covering 16 sampled case sites with the designated lead(s) responsible for local implementation of the programme. Interviews explored the process of implementation, including organisation of the programme, expectations and attitudes to the programme, funding, target populations and referral and clinical pathways. We drew on constant comparative methods to analyse the data and generate over-arching themes. We complemented our qualitative data with a survey focused on variation in the financial incentives used across sites to ensure usual primary care services recruited patients to new providers.ResultsWe identified five over-arching areas of learning for implementing this large-scale programme: 1) managing new providers; 2) promoting awareness of services; 3) recruiting patients; 4) incentive payments; and 5) mechanisms for sharing learning. In general, tensions appeared to be caused by a lack of clear roles/responsibilities between hierarchical actors, and lack of communication. Both local sites and the national NHS coordination team gained experience through learning by doing. Initial tensions with roles and expectations have been worked out during implementation.ConclusionsImplementing a national disease prevention programme is a major task, and one that will be increasingly faced by health systems globally as they aim to adjust to demand pressures. We provide practical learning opportunities for the wider uptake and sustainability of prevention programmes. Future implementers might wish to define clear responsibilities for each actor prior to implementation, ensure early engagement with new providers, offer mechanisms/forums for sharing learning, generate evidence and provide advice on incentive payments, and prioritise public and professional awareness of the programme.

Project description:BackgroundDrug overdose has become a leading cause of accidental death in the United States. Between 2000 and 2015, the rate of deaths from drug overdoses increased 137%, including a 200% increase in the rate of overdose deaths involving opioids (including opioid pain relievers and heroin). Unnecessary opioid prescribing is one of the factors driving this epidemic.ObjectivesThe primary objective of this paper is to share lessons learned while conducting a randomized trial to de-implement opioids for post-extraction pain management utilizing clinical decision support (CDS) with and without patient education. The lessons learned from conducting this trial in a real-world setting can be applied to future dissemination and implementation oral health research.MethodsThe sources informing lessons learned were generated from qualitative interviews conducted with 20 of the forty-nine dental providers involved in the study following the implementation phase of the trial. Ongoing policy, social and environmental factors were tracked throughout the study.ResultsDental providers in the trial identified the impact of training that involved health professionals sharing information about the personal impact of pain and opioid use. Additionally, they found utility in being presented with a dashboard detailing their prescribing patterns related to other dentists. For the 30 general dentists with access to the CDS, use of its portal varied widely, with most using it 10%-49% of the time related to extractions.ConclusionsIn the context of a downward trend in opioid prescribing and considering the influence of the COVID pandemic during the trial, dental providers indicated benefit in training about negative personal impacts of prescribing opioids, and personally relevant feedback about their prescribing patterns. Only modest use of the CDS was realized. Implementation of this trial was impacted by governmental and health system policies and the COVID pandemic, prompt the consideration of implications regarding continuing ways to limit opioid prescribing among dental providers.

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EBOVAC-Salone: Lessons learned from implementing an Ebola vaccine trial in an Ebola-affected country.

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EBOVAC-Salone: Lessons learned from implementing an Ebola vaccine trial in an Ebola-affected country.

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