To be noted – home blood microsampling has been used in geographically restricted pilot projects. Importantly, it is known that patients greatly appreciated this experience compared to the traditional blood sampling methods currently in use.

Applicants should in their proposal address the following:

1. 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.

• To generate an umbrella / master protocol that is acceptable for regulatory authorities in EU and non EU-European countries, and can be easily adopted for future applications (e.g. in additional patient populations, countries, by any vendor or organisation). To assure patient-centricity, feedback on the umbrella protocol by patient representatives and caregivers will be sought.

The umbrella / master protocol must include:

• • sites in at least 3 EU member states, and may include additional sites in third countries associated to Horizon Europe or other European countries; at least one of the countries must be in Eastern Europe1;
  • at least two different types (e.g., finger stick, upper arm capillary) of commercially available CE-marked microsampling devices; for clarity, at least one device should perform liquid blood sampling, the additional devices may collect dried blood.
  • routine clinical assays: i.e. blood chemistry, liver and lipid panels;
  • collection of at least 50% of microsamples by the patient and/or the caretaker; the other 50% may be taken by hospital or nursing personnel (including remote or traveling nurses);
  • collection of least 50% of microsamples at home; the project may include collections in other locations (e.g. hospitals, general practitioners, specialists’ offices) for concordance testing and establishing microsampling of capillary blood versus venous blood for routine assays
• To design, adapt, and translate patient-facing materials, obtain ethics board approvals, obtain competent/regulatory authority approvals, recruit healthy human volunteers and expand to a patient population which should be agreed upon in a project committee, collect biological samples and conduct bioanalysis according to the study protocol.
• To investigate potential errors related to the mishandling of samples and design ways to mitigate them, as well as the potentially harmful downstream effects for the individual.
• To conduct concordance analyses according to existing regulatory guidance for routine clinical assays, and define sample quality criteria (if applicable).

2. 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.

If possible, to assess the cost savings obtained with microsampling methods as compared to gathering blood in the hospital.

3. 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 publish survey results to validate the training and feedback with other patient advocacy groups.

4. 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 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.