Présentation
(Call: HORIZON-JU-IHI-2023-04-two-stage)
Website : https://ihi-project-comfort.com/
LinkedIn: https://www.linkedin.com/company/project-comfort
Background
Several microsampling devices (e.g., capillary blood collection from the upper arm and/or finger prick devices, for both liquid and dried blood sampling) are already available and authorised by competent regulatory authorities for clinical intended use with appropriate CE marking. However, their use in real-world scenarios and with specific population targets is still to be further explored to generate enough proof-of-concept to show the feasibility of their logistic clinical implementation as well as patient acceptance and clinical adoption. The Project-COMFORT clinical research study is designed with this purpose.
Objectives
The intention of Project-COMFORT is to co-create and test the processes, logistics, infrastructure, and tools required to make Patient Centric Microsampling (PCmS) a core capability for increasing patient choice by enabling alternatives to in-clinic venous blood-draw with home, self-collection with a capillary blood-draw. One of the initial steps towards this is to build evidence with a new study utilising a variety of PCmS techniques across different patient groups, disease populations and countries in the EU and UK, to show the real-world utility of this approach in the clinical setting.
There are 4 main project objectives that must be addressed to realise the vision of PCmS becoming a viable and accepted option in clinical and healthcare settings for patient benefit.
- Create an optimised ‘Gold Standard’ infrastructure and workflow for PCmS across Europe as a proven and reliable alternative to venipuncture
- Create a harmonised and clear regulatory and HTA pathways, standards and acceptability, measures and cost-benefit models across Europe
- Gather definitive evidence to draw a citable ‘line in the sand’ for future research to support decisions to integrate PCmS into decentralised trials and care pathways
- Foundation for future: Enable access to the developed PCmS scientific findings, tools and assessment measures for rapid uptake and integration of PCmS approaches into decentralised clinical studies and healthcare.
The project planned a study in 5 countries (UK, Spain, Sweden, Czech Republic, France) using existing CE-marked collection devices for a variety of standard blood tests in patient populations with specified conditions including participants from groups such as the elderly, cardiovascular disease, oncology and paediatrics, that will help to assess detection of a wide range of values.
The study will be carried out in two parts. Part A will confirm the existing equivalence of PCmS samples with venous blood draws as a basis for Part B, and will start to investigate patient sampling preferences. Part B will go on to demonstrate robustness and feasibility of self-collection in the remote/at-home-setting, understand training needs, patient acceptability and logistics involved in the process.
Participation of the Institut Pasteur : INVOLvE and CRBIP teams
The Institut Pasteur is involved in developing the protocol, selecting sampling devices, developing the protocol and toolbox for donor kits, recruiting donors, and analyzing and storing samples.
The donors recruited are elderly people.
- INVOLvE : donor recruitment, and sampling
- CRBIP : sample analyzing and banking
