Grants to Promote Uptake of EFS for Clinical and Innovation Excellence in the EU

Deadline: 20-Sep-22

The European Commission (EC) is offering grants for Setting up a harmonised methodology to promote uptake of early feasibility studies (EFS) for clinical and innovation excellence in the European Union (EU).

This topic seeks to develop and validate a methodology for EFS that is compliant with EU regulations, including a working methodology, easily accessible online, with information on how to undertake such studies, the process and requirements to follow and fulfil.

It also aims to bring together the relevant stakeholders that could have an interest in EFS and to facilitate use-cases where technologies would run the newly developed EFS methodological framework in order to test it and recommend any adjustments to be made to the methodology.

Details

The project would entail the following:

• Research & analysis, including a review of existing international, EU and national guidelines, standards and best practice experiences. This would also include a survey of potential current gaps, barriers and challenges to undertaking EFS in the EU, taking into account the interplay between the different relevant current and future EU regulations.
• Development of an EU methodology for EFS:
  • The methodological framework would include:
    • definition and scope, including legal considerations;
    • the place of EFS in the development pathway of health technologies and when there is an added value for EFS;
    • the type of data required to conduct an EFS (technical data, preclinical data, number of patients, etc.);
    • process evaluation, methods and tools, including statistical tools adapted to the analysis of EFS results, and tailored to the needs and specificities of different health technologies, including digital and mobile health technologies;
    • the contribution of EFS to making more patient-centred devices;
    • the contribution of EFS to the development of training plans for healthcare professionals that would in turn improve the use of devices.
  • Recommendations for best practices, addressing also ethical aspects from the outset, and contractual elements.
  • Development of a sustainable, freely-accessible online portal, hosted and maintained by the consortium, which would act as a repository for the methodological framework and the best practices, and which would facilitate interactions between stakeholders with an interest in EFS.
• Facilitate the creation of a sustainable stakeholder network at national and EU level:
  • The network would promote the conduct of EFS and continue to gather experience from subsequent studies where appropriate and relevant to inform the EU EFS methodology.
  • Target groups include patient organisations and representatives, healthcare professionals, research institutions and hospitals, health technology developers, including SMEs, regulators, and HTA bodies.
• The selection of dedicated use-cases to inform, refine and validate the framework:
  • The purpose of selected use-case technologies will be to undertake an EFS in the EU, whilst applying the methodology developed by the selected project, in order to test the methodological framework and evaluate the benefits for the conformity assessment process and patient access.
  • Learnings acquired on the use-cases will be used to adapt and finalise the methodological framework, and, where necessary, the blueprints and templates.
  • During the project execution, the consortium will define specific criteria and processes to determine which use-cases can be selected.

Funding Information

The check will normally be done for the coordinator if the requested grant amount is equal to or greater than EUR 500 000, except for:

• public bodies (entities established as a public body under national law, including local, regional or national authorities) or international organisations; and
• cases where the individual requested grant amount is not more than EUR 60 000 (lowvalue grant).

Expeceted Outcomes

The research and innovation action to be supported under this topic is expected to deliver results including a methodology for EFS in the EU, to facilitate compliance with the relevant legislation applicable in the EU, and a stakeholder network. It will contribute to all of the following expected outcomes:

• Patients and/or their representatives are engaged and contribute from the start of the development process of innovative health technologies.
• EU-wide and national regulators, health technologies assessment (HTA) bodies and notified bodies benefit from novel and robust methodologies, gain early knowledge on innovations, and can better anticipate and plan conformity assessment processes.
• Researchers, healthcare professionals, medical societies, and hospitals:
  • contribute to the early generation of quality data;
  • strengthen the understanding of disease management and treatment options that could inform future medical guideline development;
  • provide input on innovation development;
  • take part in the development of “hubs of clinical excellence”, thereby attracting investment into existing research and innovation as well as other areas (spin-off technologies).
• Health technology developers including those developing medical devices, drug-device combination products, imaging equipment and in-vitro diagnostics as well as SMEs, will have: 
• a controlled opportunity to assess their technologies and develop methods and best practices to support them in designing and conducting EFS when relevant.
• early insights into the technology concept, patient characteristics and human factors that may impact technological performance, technology safety, future technological modifications or operator technique refinements.
• a framework that will help to inform the subsequent development phase. In particular it will aid designing higher quality clinical studies while mitigating future patient risk, at the same time facilitating the conduct of future clinical investigations in broader patient populations.
• For SMEs, particularly, having access to a methodology and stakeholder network can facilitate the conduct of early feasibility studies. The availability of high-quality data early in the health technology development process would further support investment and development decisions.

Eligibility Criteria

To be eligible for funding, applicants must be established in one of the eligible countries, i.e.:

• the Member States of the European Union, including their outermost regions;
• the Overseas Countries and Territories (OCTs) linked to the Member States;
• eligible non-EU countries:
  • countries associated to Horizon Europe;
  • low- and middle-income countries.

For more information, visit European Commission.

For more information, visit https://bit.ly/3OwHITZ