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

有充分的证据表明，迫切需要新的抗生素来对付已存在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全球新药渠道的匮乏。多种因素推动抗菌素耐药性（AMR）的发展和传播。一些重要的持续行动正在进行中，试图解决这一AMR挑战——但这些行动主要集中在新抗生素上。尽管细菌感染诊断的发展已被确定为优先事项，但在同行评议的诊断文献中缺乏深入的分析。因此，本提案侧重于开发和使用诊断方法来应对抗菌素耐药性挑战。从理论上讲，诊断方法有可能迅速帮助管理抗生素耐药性，因为开发时间较短，因此诊断方法可以更快地用于对抗超级细菌的战斗。此外，有充分的证据表明，使用诊断方法可以减少不必要的抗生素使用，但迄今为止，这未能转化为开发和使用适当的技术。该项目提供了一项横跨七个欧盟国家的前瞻性研究，以促进利益相关者对广泛细菌感染诊断的潜在创新途径（包括开发、验证、引入和激励）的评估——以竞争公共和/或私人资源的场景呈现。该项目的假设是，某些方案对利益相关者的临界质量具有吸引力，而其他方案则不受支持，因此不太可能在中短期内可行。该项目的贡献将是在利益相关者群体和国家内部以及在利益相关者群体和国家之间清晰透明地展示与支持特定创新途径的情景相关的共识、分歧和不确定性，并详细说明评估中存在相似、差异和不确定性的因素。该项目将对一系列利益相关者，特别是在短期内，研究资助者，研究人员和小公司产生变革，他们通常无法自己进行或访问此类分析。该项目的影响目标是推动向特定可行途径提供更多资源和政策支持，从而加快所需诊断方法的开发。短期内，这可以通过加强利益相关者的协调和减少失误（投资于支持不足、无法满足利益相关者需求的方法）来实现。研究所和高等教育研究所除学术界外，还积极传播其研究成果，特别是向政策和工业对象传播研究成果。鉴于政策和行业以及学术界对抗菌素耐药性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。首先要准备提交的四篇学术文章和一份政策简报。我们将通过双边讨论、研讨会和演讲，利用与正在进行的关键倡议并行的优势。我们的影响计划包括向这些人以及政策制定者、研究人员/行业/临床医生进行介绍，确保英国和国际上对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.