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TOPIC : The value of diagnostics to combat antimicrobial resistance by optimising antibiotic use

Topic identifier: IMI2-2017-13-03
Publication date: 30 November 2017

Types of action: IMI2-RIA Research and Innovation action
DeadlineModel:
Opening date:
two-stage
30 November 2017
Deadline:
2nd stage Deadline:
28 February 2018 17:00:00
06 September 2018 17:00:00

Time Zone : (Brussels time)
  Horizon 2020
Topic Description
Specific Challenge:

Huge amounts of antibiotics are prescribed and consumed unnecessarily in almost all healthcare systems. The misuse of antibiotics has created a huge global health crisis. Prudent use of antibiotics is urgently required in order to protect the efficacy of our currently available antibiotics. Diagnostics have the potential to provide more targeted, accurate use of antibiotics which is in the best interest of patients and the wider population. Diagnostics play a critical role in guiding treatment in infectious diseases. However, the value of diagnostics as a critical component of antimicrobial stewardship programmes is not fully established throughout Europe, with guidelines, funding and policy varying in each country. This hinders the adoption and use of currently available diagnostic tests by health professionals, as well as the development of advanced or innovative diagnostic tools. Therefore, a pan-European approach is required, to demonstrate the medical, economical and public health value of diagnostics for combating AMR.

Scope:

The main objective of this action is to understand, demonstrate, and quantify the value of diagnostics and the obstacles to their adoption and use in the framework of a Standardised Care Network in order to combat antimicrobial resistance (AMR) by optimising antibiotic use in Europe.

The overuse of antibiotics and the underuse of diagnostics occur within the entire breadth of healthcare. It is a major issue especially in the ‘community’ setting (e.g. non-hospital clinics, private physician offices, para-medical clinics) where the majority of human antibiotics are used, most of which are inappropriately and unnecessarily prescribed. It is crucial to demonstrate both the economic and clinical value of diagnostics to health systems and purchasers.

Health economic models for the use of diagnostics must be developed to:

  • address the costs and benefits of the use of diagnostics and their impact on antibiotic prescribing;
  • propose funding models (e.g. research incentives, reimbursement framework, adoption motivation) which would facilitate the development, introduction, deployment and use of diagnostics into routine medical care.

A global roadmap must be defined to promote the use and development of diagnostic tools that would have distinct and clearly defined objectives: (i) avoiding unnecessary antibiotic use; (ii) optimising patient treatment and antibiotic use; (iii) identifying high-risk patients and/or pathogens for targeted and personalised antibiotic therapy; (iv) using diagnostics in clinical trials for supporting the development of new anti-infective approaches (prophylactic or therapeutic); (v) boosting innovation for new diagnostic development.

The action aims at providing clinical evidence to demonstrate the medical value, healthcare benefit and economic viability of diagnostic tests for combatting antibiotic resistance and improving patient outcome in conditions such as community-acquired acute respiratory tract infection (CA-ARTI).

Expected Impact:

Expected impact will be the reduction of antibiotic use and AMR resulting in improved patient care through better routine use of diagnostics. This would happen thanks to a raised awareness of health professionals and patients on the necessity to effectively replace empiric antibiotic therapy with targeted therapy when required, particularly for acute respiratory tract infections (ARTIs) with short-term health benefits for patients, short-term economic benefits for the healthcare system, and mid-term / long-term benefits on reducing antibiotic resistance.

The main expected impacts should be: (i) optimum use of diagnostic tests in CA-ARTI for achieving improved patient outcomes, reduction in the inappropriate use of antibiotics, and decrease in the incidence of key antibiotic-resistant pathogens; (ii) wide dissemination of evidence-based conclusions that will sensitise the medical and patient communities, as well as decision makers, to the clinical and economic value of diagnostics; (iii) incorporation of guidance using diagnostic tests and testing algorithms in national and international guidelines; (iv) assistance to regulatory bodies to facilitate adoption of diagnostic tests into wider routine practice; (v) assistance to health technology assessment (HTA) bodies to enable appropriate, fit-for-purpose assessment of the clinical value of diagnostics; (vi) reform of pricing policies (including reimbursement) related to diagnostic tests, according to the demonstrated or anticipated medical value and health outcomes.

New health economic models demonstrated through the project will lead to new pan-European guidelines and algorithms to facilitate the widespread introduction, deployment, adoption and reimbursement of existing and new diagnostics to guide appropriate antibiotic use and reduce unnecessary antibiotic prescribing. Economic models will illustrate to governments, third-party payers and healthcare providers the economic feasibility and benefits of utilising diagnostics to guide appropriate antibiotic prescribing in various healthcare settings.

Topic conditions and documents

Please read carefully all provisions below before the preparation of your application.

The IMI2 13th Call for proposals topic text as well as the Call Conditions are available here.

 The budget breakdown for this Call is given at the end of the Call topics text, in the Call Condtions section, as well as the following information:

1.   Eligible countries: described in article 10(2) of the Rules for participation in Horizon 2020 and in article 1 of the Commission Delegated Regulation related to IMI JU.

2.   Eligibility and admissibility conditions: described in the IMI2 Manual for evaluation, submission and grant award. See also the Commission Delegated Regulation related to IMI JU.

Proposal page limits and layout: Please refer to Part B of the proposal template in the submission tool below.

3.   Evaluation:
Submission and evaluation process, including evaluation criteria and procedure, scoring and threshold are described in the IMI2 Manual for submission, evaluation and grant award. See also the proposal templates for your specific action in section 5, below.

4.   Indicative time for evaluation and grant agreement:
Notification of outcomes of stage 1 evaluations: maximum 5 months from deadline for submitting proposals.
Notification of outcomes of stage 2 evaluations: maximum 5 months from deadline for submitting full proposals.

Signature of grant agreements: maximum 3 months from the date of informing successful applicants.

5.   Proposal templates, evaluation forms and model grant agreements (MGA), clinical trials template:

IMI2 Research and Innovation Action (IMI2-RIA) and Innovation Action (IMI2-IA):

Proposal templates are available after entering the submission tool.

Standard evaluation form RIA 

IMI2 Model Grant Agreement
:
Members of consortium are required to conclude a consortium agreement prior to the signature of the grant agreement.

Clinical trial template:
The Clinical Trial template is compulsory at stage 2 only !

IMI2 Coordination and Support Action (IMI2-CSA):

Proposal templates are available after entering the submission tool.

Standard evaluation form CSA

IMI2 Model Grant Agreement
:
Members of consortium are required to conclude a consortium agreement prior to the signature of the grant agreement.

Clinical trial template:
The Clinical Trial template is compulsory at stage 2 only !

6.   Open access must be granted to all scientific publications resulting from Horizon 2020 actions.

Where relevant, proposals should also provide information on how the participants will manage the research data generated and/or collected during the project, such as details on what types of data the project will generate, whether and how this data will be exploited or made accessible for verification and re-use, and how it will be curated and preserved.

Open access to research data
The Open Research Data Pilot has been extended to cover all Horizon 2020 topics for which the submission is opened on 26 July 2016 or later. Projects funded under this topic will therefore by default provide open access to the research data they generate, except if they decide to opt-out under the conditions described in Annex L of the H2020 main Work Programme. Projects can opt-out at any stage, that is both before and after the grant signature.

Note that the evaluation phase proposals will not be evaluated more favourably because they plan to open or share their data, and will not be penalised for opting out.

Open research data sharing applies to the data needed to validate the results presented in scientific publications. Additionally, projects can choose to make other data available open access and need to describe their approach in a Data Management Plan.

Projects need to create a Data Management Plan (DMP), except if they opt-out of making their research data open access. A first version of the DMP must be provided as an early deliverable within six months of the project and should be updated during the project as appropriate. The Commission already provides guidance documents, including a template for DMPs. See the Online Manual.

Eligibility of costs: costs related to data management and data sharing are eligible for reimbursement during the project duration.

The legal requirements for projects participating in this pilot are in the article 29.3 of the Model Grant Agreement.

7. Additional documents:

Summary of the most relevant provisions for participating in IMI2 actions

IMI2 - 2nd Amendment to the Annual Work Plan 2017

IMI2 Regulators Guidance tool for researchers

IMI JU derogation to H2020 Rules for Participation  

Horizon 2020 Rules for Participation 

Horizon 2020 Regulation of Establishment

Horizon 2020 Specific Programme

 

Members of consortium are required to conclude a consortium agreement prior to the signature of the grant agreement.

Additional documents

  • IMI2 Call 13 stage 1 - Flash Call Info Report en
  • IMI2 Call 13 stage 2 - Flash Call Info Report en

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