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

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.

We will facilitate stakeholder appraisal of pathways to development and use of diagnostics to address the AMR challenge. We address four questions: 1.What are the stakeholders' priorities for the types of diagnostics to manage AMR? 2.What informs stakeholder preferences? 3.What scenarios can best deliver the preferred diagnostics? 4.Where is there agreement or obstacle to progress in advancing particular scenarios? The project has four phases. Phases A & B involve a pan-European survey developed to ascertain the technical (and other) characteristics of diagnostics that stakeholders in different nations would most support and the associated challenges they identify - delivered as an online stated preference survey. We expect to detect statistically significant inter-group and international differences in priorities. Survey results will inform the design of scenarios for phase C, which centres on Multicriteria Mapping (MCM) interviews with representatives from stakeholder groups around innovation pathways for diagnostics. MCM allows stakeholders to appraise scenarios (e.g. funding models/ incentive schemes) using any criteria they deem appropriate (i.e. not limited by the starting assumptions of the investigators, and open to creation of scenarios devised by participants). MCM allows comparisons across scenarios and across stakeholder groups in numerous ways, without reducing complex data to linear single ordering of preferences. Instead MCM allows differences between priorities and problems that stakeholders raise to be revealed, displayed, and discussed. Results may demonstrate incompatibility with stakeholders (and elimination) of some scenarios but will also show obstacles to be overcome to allow other scenarios to be developed and may reveal areas of consensus. Phase D involves production of up to four academic articles for submission, the launch of a policy briefing and extensive meetings in Europe, the US and China to encourage use of the research findings.

This research project seeks to produce and disseminate robust results that will influence the allocation of resources into innovation pathways that are more likely to lead to wide use of the needed diagnostics to detect and manage AMR.

Who will benefit from this research and how?

Influencing policy makers at a national level to incentivise diagnostic technologies:

Policy makers in national governments e.g. in ministries with oversight of science, technology and innovation policy, or in international NGOs will be able to consider the results of this project in order to formulate policies to incentivise public and private actors to undertake the development, produce or use diagnostic technologies that are identified as being desired by stakeholders in particular contexts.

Influencing the public sector and charitable funding of biomedical research towards developing the diagnostics necessary in Europe:

This project's findings will aid public sector and charitable organisations funding of biomedical research, especially those seeking to fund research on biomarkers and diagnostics to allocate resources and design programmes that will be better targeted at developing the diagnostics that are needed in the European context we will study. These include a wide range of funders in the UK, Europe and beyond (e.g. Wellcome Trust, MRC, IMI, The Gates Foundation).

Raise awareness of diagnostics amongst biomedical researchers to help decision-making on research activities towards most crucial areas:

Research scientists undertaking biomedical research that may lead to diagnostics will gain an overview of the needs, opportunities and challenges involved in diagnostic test development. This may help them to make decisions about the avenues of research that they pursue.

Enabling investors to understand investment opportunities across markets to develop appropriate funding of diagnostic technologies:

Private sector investors (e.g. those supporting early stage biotech firms) will benefit from the research by being able to understand opportunities in a range of markets, as well as being able to communicate their priorities, challenges and needs to other stakeholders.

Small and large firms (i.e. those developing, manufacturing and distributing products or offering testing services) will benefit from the project which will help to characterise diverse business environments and niches that they may wish to invest in, as well as allowing them to communicate to other stakeholders their priorities, challenges and needs. In particular the results will demonstrate to them particular business models that should be avoided or pursued in particular markets.

Help direct the development of appropriate technologies by enabling health practitioners and patients to communicate their needs:

Clinicians, epidemiologists, pathologists, and patient groups are the users and consumers of diagnostic technologies studied in this project. They will all benefit from this research as it will allow them to communicate their needs for particular kinds of diagnostics to detect and manage AMR infections. They will also be able to express views on the types of innovation pathways that they deem appropriate to generate diagnostic innovation.

Improve the selection of technologies for reimbursement and adoption:

Health payers and health technology assessment agencies will benefit from this research which allows them to make clear to technology developers their thinking in the selection of appropriate technologies for reimbursement. The project may facilitate firms to make better thought out approaches or to approach agencies in countries that are a better match for their offering.