The Innovative Health Initiative (IHI) is a public-private partnership (PPP) between the European Union and the European life science industries, and these partners sit on our Governing Board. Its main objective is to translate healthcare research and innovation into tangible benefits for patients and society. It is also looking for Europe to become a reference in the fields of interdisciplinary, sustainable and patient-centered health research.

Any organisation established in the EU or a country associated to Horizon Europe is eligible to receive IHI funding. In practice, IHI funding primarily supports the participation in its projects of organisations like universities, research organisations, patient organisations, small and medium-sized enterprises (SMEs), and mid-sized companies. Depending on the type of call for proposals, larger companies may also be eligible to receive IHI funding. Details of who can receive funding is spelt out in the call texts.

Contributing to IHI: industry partners and contributing partners

Large companies that are members of the IHI industry partners contribute to the programme, primarily through 'in-kind' contributions (e.g. their researchers' time, laboratories, data, compounds). They can also make cash contributions. IHI contributing partners provide resources to IHI in the same way.

At least 45% of each project's budget has to come from industry partner / contributing partner contributions (in exceptional cases, a lower percentage may be allowed).

Explanation of this specific topic

The overall aim of the project generated from this topic is to create and validate the infrastructure and logistics for blood collection by the patient and/or caregiver at home as a healthcare tool and an alternative to the current gold standard venous blood for routine clinical assays. This project will employ only commercially available CE-marked microsampling devices, according to their intended use. The development of new devices for blood sampling or of new clinical assays / analytes is not the focus of this project, and no new clinical assays will be evaluated. Similarly, given their current maturity, home sample analysis is out of scope.

Applicants should in their proposal address the following:

Demonstration of concordance between patient-centric microsampling techniques and venipuncture. This requires delivery of a framework across Europe for establishing concordance between capillary blood as collected by microsampling devices outside of traditional collection setting by the patient and/or caregiver, versus the gold standard venous blood, for routine clinical assays.

Validation of the logistics of sample collection and shipping, standardising central lab analysis. This requires identification of an optimum workflow for device ordering, fulfilment, shipping, at-home collection and return to central labs and a seamless integration of microsampling into current central lab processes, accessioning, analysis and reporting.

Education and medical & patient acceptability:

• To deliver training materials for patients, caregivers and clinical trial sites, taking into account the variety of patients' and caregivers' ages, abilities, etc., and ensuring smooth behind-the-scenes shipment logistics and support.
• To develop guidelines for compiling training materials to meet expectations from different training recipients, such as clinical sites, patients, caregivers, telehealth and home health providers, leveraging previous feedback collected from users (patients, caregivers, principal investigators (PIs) and medical personnel), including to develop training by telehealth.
• To develop a plan to collect patient, caregiver and medical personnel (site staff, PIs, trial coordinator) experience and feedback:
  • to develop a well-designed questionnaire that will be used either electronically or in paper format, develop tool(s) to collect feedback and store the information, pilot the use, refine the questionnaire and data base as needed;
  • to implement the questionnaire to collect feedback from different groups (patients and caregivers, medical personnel, regulators, device manufactures);
  • to maintain a database of information collected and perform data analysis to obtain patient acceptability scores;
  • to get insights into research questions related to the implementation of microsampling which are described in 'Expected outcomes' (see above).
• To publish survey results to validate the training and feedback with other patient advocacy groups.

Regulatory acceptability and implementation in clinical practice in the EU, other non-EU European countries and the US:

• To prepare an overview of the regulatory landscape of microsampling at home per country in the EU, third countries associated to Horizon Europe, and other European countries, and to conduct an in-depth exploration in those countries that might be suitable for the microsampling logistics modelling.
• To establish an early and continuous dialogue with the European Medicine Agency (EMA) Innovation Task Force, in addition to local regulatory agencies of the EU, and relevant authorities of other non-EU European countries and the FDA:
  • to assess acceptability with regulators and seek prospective input on the umbrella / master protocol, choice of countries and approach to validating the logistics;
  • to discuss the best strategy/timing for qualification and/or integration of project outputs into regulatory practices, prepare relevant documents (e.g. briefing books, EMA guidance document) to share project results, request scientific and qualification advice, and seek a harmonisation with the regulatory agencies from other non-EU European countries and the FDA, which is key to global clinical trials of new therapeutics.
• To interact with policy makers, HTA experts, payers, and advocacy groups to facilitate the implementation of project results in clinical practice throughout the EU, and other non-EU European countries and the US.

In case of interest, both as possible coordinator or partner,  please click on "m'interessa" and we will contact you.