Rojek Amanda M, Horby Peter W
Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Old Road Campus, Roosevelt Drive, Oxford, OX3 7FZ, UK.
International Severe Acute Respiratory and emerging Infections Consortium, University of Oxford, Oxford, UK.
BMC Med. 2016 Dec 19;14(1):212. doi: 10.1186/s12916-016-0760-x.
Emerging and epidemic infectious disease outbreaks are a significant public health problem and global health security threat. As an outbreak begins, epidemiological investigations and traditional public health responses are generally mounted very quickly. However, patient-centred research is usually not prioritised when planning and enacting the response. Instead, the clinical research response occurs subsequent to and separate from the public health response, and is inadequate for evidence-based decision-making at the bedside or in the offices of public health policymakers.
The deficiencies of the clinical research response to severe acute respiratory syndrome, pandemic influenza, Middle East respiratory syndrome coronavirus and Ebola virus demonstrate that current research models do not adequately inform and improve the quality of clinical care or public health response. Three suggestions for improvements are made. First, integrate the data and sample collection needs for clinical and public health decision-making within a unified framework, combined with a risk-based, rather than a discipline-based, approach to ethical review and consent. Second, develop clinical study methods and tools that are specifically designed to meet the epidemiological and contextual challenges of emerging and epidemic infectious diseases. Third, invest in investigator-led clinical research networks that are primed and incentivised to respond to outbreak infections, and which can call on the support and resources of a central centre of excellence.
It is crucial that the field of epidemic science matures to place patients at the heart of the response. This can only be achieved when patient-centred research is integrated in the outbreak response from day one and practical steps are taken to reduce the barriers to the generation of reliable and useful evidence.
新发和流行性传染病暴发是重大的公共卫生问题及全球卫生安全威胁。疫情开始时，通常会很快开展流行病学调查和传统公共卫生应对措施。然而，在规划和实施应对措施时，以患者为中心的研究通常未被列为优先事项。相反，临床研究应对措施在公共卫生应对措施之后进行，且与之分开，不足以在床边或公共卫生政策制定者办公室进行循证决策。
针对严重急性呼吸综合征、大流行性流感、中东呼吸综合征冠状病毒和埃博拉病毒的临床研究应对措施存在的不足表明，当前的研究模式未能充分为临床护理质量或公共卫生应对措施提供信息并加以改善。现提出三点改进建议。第一，在统一框架内整合临床和公共卫生决策所需的数据及样本收集需求，并采用基于风险而非基于学科的伦理审查和同意方式。第二，开发专门设计用于应对新发和流行性传染病的流行病学及背景挑战的临床研究方法和工具。第三，投资于由研究者主导的临床研究网络，这些网络做好准备并有动力应对疫情感染，且能够借助卓越中心的支持和资源。
流行病科学领域必须成熟起来，将患者置于应对措施的核心位置，这一点至关重要。只有从第一天起就将以患者为中心的研究纳入疫情应对，并采取切实措施减少生成可靠且有用证据的障碍，才能实现这一目标。
