European & Developing Countries Clinical Trials Partnership - Ebola

背景埃博拉病毒病(EVD)在西非的爆发催生了一系列研究和开发活动，这些活动的重点是提供有效的治疗、诊断和预防干预措施。然而，要成功测试和实施这些干预措施，就需要在受影响国家提供正常运作的卫生研究基础设施，提高研究能力，以及受影响人口愿意参与研究和开发活动。受目前埃博拉病毒病疫情影响的区域，在多年的国内冲突使卫生基础设施严重受损或被摧毁后，其研究和保健提供系统非常薄弱。自疫情爆发以来，现有的研究和保健服务以及现有的人力资源已完全被施加在它们身上的需求压垮了。有鉴于此，欧洲和发展中国家临床试验伙伴关系(EDCTP)和热带病研究和培训专门方案(WHO-TDR)决定发起一项倡议，以满足在导致卫生紧急情况的传染病暴发期间围绕业务和其他临床研究的长期解决方案和能力建设。英国医学研究理事会(MRC UK)也承诺参与这一联合倡议。呼吁建议概述目前在受影响地区进行的研究活动集中在埃博拉病毒的治疗、预防和遏制上。然而，仍然需要采取侧重于加强人类和卫生系统能力的办法，包括制定应对紧急情况的社会性质的办法。这是一个利基市场，将通过此次提案呼吁解决这一问题，该提案将支持以下活动：？医护人员和实验室人员在紧急情况下进行临床试验的能力？卫生系统和临床试验场地的准备情况？紧急情况下研究管理中的伦理和监管问题？社区和国家卫生当局的支持和参与？制定指导方针和政策，以确保医护人员在处理感染材料时的保护和安全。这一呼吁将补充、增值和维持在当前紧急反应期间取得的成果。所支持的工作将灌输长期的准备，不仅是针对埃博拉疫情，而且是针对未来可能由其他新出现的传染病暴发引起的任何紧急情况。

BackgroundThe outbreak of Ebola virus disease (EVD) in West Africa has catalysed a number of research anddevelopment activities that are focused on delivering effective therapeutic, diagnostic and preventiveinterventions. However, the successful testing and implementation of these interventions requires theavailability of functioning health research infrastructures and increased research capacity in theaffected countries, as well as the willingness of affected populations to engage in research anddevelopment activities. The region affected by the current EVD outbreak had very weak research andhealth care delivery systems following years of civil conflict that left health infrastructures badlydamaged or destroyed. Since the outbreak started, existing research and health care services andavailable human resources have been completely overwhelmed by the demand placed upon them. Inview of this, the European & Developing Countries Clinical Trials Partnership (EDCTP) and the SpecialProgramme for Research and Training in Tropical Diseases (WHO-TDR) have decided to launch a Callfor Proposals to cater for long-term solutions and capacity development around operational and otherclinical research during infectious disease outbreaks resulting in health emergencies. The UK MedicalResearch Council (MRC UK) has also committed to participate in this joint initiative.Overview of the Call for ProposalsThe current research activities being conducted in the affected area are focused on the treatment,prevention and containment of EVD. However, there is still a need for approaches that focus onstrengthening human and health system capacity, including developing approaches that address thesocial nature of the emergency situation. This is a niche that will be addressed by this Call forProposals, which will support activities focusing on:? Capacities of health care workers and laboratory personnel in the conduct of clinical trials in anemergency context? Health system and clinical trial site preparedness? Ethics and regulatory issues in the management of research during emergencies? Community and national health authority support and engagement? Development of guidelines and policies to ensure the protection and safety of health care givers inthe handling of infective materials.This Call for Proposals will complement, add value to and sustain the gains that have been achievedduring the current acute response. The work supported will instil long-term preparedness, not only forEVD, but for any future emergencies that may be caused by outbreaks of other emerging infectiousdiseases.