Foresight Study on European Stakeholder Appraisal of Diagnostics to Manage Anti-Microbial Resistance

有充分的文件证明，迫切需要新的抗生素来对抗已建立的和新出现的耐药细菌--所谓的“超级细菌”--但我们目前在这一领域面临着一条稀缺的全球新制剂管道。多种因素推动了抗菌素耐药性(AMR)的发展和蔓延。正在进行的一些重要举措正在努力应对这一AMR挑战，但这些举措主要集中在新的抗生素上。尽管细菌感染诊断学的发展已被确定为优先事项，但同行评议的文献中缺乏关于诊断学的深入分析。出于这个原因，本提案侧重于开发和使用诊断学来应对AMR挑战。从理论上讲，随着开发时间的缩短，诊断技术有可能迅速帮助抗生素耐药性的管理，因此诊断技术可以更快地应用于与超级细菌的斗争中。此外，有很好的证据表明，使用诊断方法可以减少不必要的抗生素使用，但到目前为止，这还没有转化为适当技术的开发和使用。该项目提供了一项横跨七个欧盟国家的前瞻性研究，以促进利益相关者评估各种细菌感染诊断方法的潜在创新途径(包括开发、验证、引入和激励)-呈现为竞争公共和/或私人资源的情景。该项目的假设是，一些情景对足够多的利益攸关方具有吸引力，而另一些情景将得不到支持，因此不太可能在短期到中期内可行。该项目的贡献将是在利益攸关方群体和国家内部和国家之间清楚和透明地展示，在支持特定创新途径的情景方面存在共识、分歧和不确定因素，并详细说明评估中的相似、差异和不确定因素。该项目将对一系列利益攸关方具有变革性，特别是在短期内，研究资助者、研究人员和小公司，他们自己往往无法进行或获得这种分析。该项目的影响目标是推动向特定可行途径提供更多的资源和政策支持，从而加快开发所需的诊断方法。短期内，这将通过加强利益相关者的协调和减少失误(投资于不能满足利益相关者需求的缺乏支持的方法)来实现。SPRU和OHE积极传播他们的研究，特别是向政策和行业受众，以及学术界。鉴于政策和行业以及学术界对AMR解决方案的巨大兴趣，我们计划通过不同的方式非常积极地传播这项研究的成果。起点将是准备提交的四篇学术文章和一份政策概要。我们将通过双边讨论、研讨会和演讲，利用与正在进行的主要举措并驾齐驱的优势。我们的影响计划包括向这些人和政策制定者、研究人员/行业/临床医生进行演示，确保英国和国际上关于AMR的研究更好地了解下游观点，使他们能够超越“科学推动”的方法。

It is well-documented that there is a desperate need for new antibiotics against established and emergent drug-resistant bacteria - the so called 'superbugs' - but we currently face a thin global pipeline of new agents in this area. Multiple factors drive the development and spread of antimicrobial resistance (AMR). A number of important on-going initiatives are underway to try to address this AMR challenge - but these are primarily focused on new antibiotics. There is a lack of an in-depth analysis in the peer-reviewed literature regarding diagnostics, even though development of bacterial infection diagnostics has been identified as a priority. For this reason, this proposal focuses on the development and use of diagnostics to address the AMR challenge. In theory, diagnostics have the potential to rapidly aid the management of antibiotic resistance as development times are shorter and so diagnostics can be brought into use more quickly in the battle against super bugs. Moreover, there is good evidence that the use of diagnostics can reduce unnecessary antibiotic use, but this has so far failed to translate into the development and use of appropriate technologies.This project provides a foresight study across seven EU nations to facilitate stakeholder appraisals of potential innovation pathways (covering development, validation, introduction and incentives) for a wide range of bacterial infection diagnostics - presented as scenarios that compete for public and/or private resourcing. The project's hypothesis is that some scenarios are attractive to a critical mass of stakeholders, while others will not be supported and are therefore unlikely to be viable in the short to medium term. The project's contribution will be to demonstrate clearly and transparently within and across stakeholder groups and countries, where there is consensus, divergence and uncertainties in relation to scenarios to support particular innovation pathways, as well as detailing the factors that underlie similarities, differences and uncertainties in appraisals. The project will be transformative for a range of stakeholders particularly, in the short term, research funders, researchers and small firms, who are often unable to undertake or access such analysis themselves. The project's impact aim is to drive higher resourcing and policy support towards particular viable pathways and therefore accelerate development of the needed diagnostics. In the short term this would occur through enhanced stakeholder co-ordination and by reducing missteps (investment in poorly supported approaches that do not meet stakeholder needs).SPRU and OHE are active in disseminating their research especially to policy and industry audiences, in addition to academia. Given the great policy and industry, as well as academic, interest in AMR solutions we plan to disseminate the outputs of this research very actively, via different means. The starting point will be the preparation of four academic articles for submission, and a policy brief. We will take advantage of running alongside key on-going initiatives via bilateral discussions, workshops and presentations. Our impact plan includes presentations to these and to policy makers, researchers/ industry/ clinicians, ensuring that UK and international research on AMR is better informed of downstream viewpoints allowing them to move beyond a "science push" approach.