Summary
Blood tests are a common feature of patient care and clinical studies. Yet having a blood test still requires the patient to go to a hospital or clinic and this can be burdensome, especially for people who require regular tests. But what if patients or their caregivers could collect a blood sample in the comfort of their own home and simply send it to the lab for analysis?
Turning this vision into a reality is the ultimate goal of Project-COMFORT. The project focuses on patient-centric microsampling techniques, which collect less than half a millilitre of blood.
While microsampling devices already exist, they are not widely used and questions remain on issues such as how to manage the logistics of sending samples in the post, whether the amount of blood collected is enough to run certain tests, and whether the results are accurate.
Project-COMFORT aims to co-create and test the logistics, infrastructure and tools needed to make microsampling a standard part of healthcare and an acceptable alternative to conventional blood tests.
As a first step, the project will set up infrastructure and workflows for microsampling. The starting point for this effort will be existing microsampling devices covering different types of blood tests (including standard blood counts, measures of organ function, hormones, and tests for drugs that are therapeutically monitored). Experts in logistics and microsampling devices will collaborate with representatives of primary care providers, laboratories, regulators and the patient community to develop logistical and infrastructure approaches to integrate the use of these devices into clinical studies and healthcare.
Crucially, the project will carry out a clinical study with human participants to assess how well the results from microsampling devices match results from standard blood tests. The project will work closely with patients to ensure that they are comfortable with the devices as well as the practicalities of collecting and sending off their own blood samples.
Microsampling devices touch on several different regulatory pathways, so the project will work with regulators at both European and national level (linking to the UK and US regulators as well) to deliver a single, harmonised regulatory pathway for the uptake and use of microsampling in clinical studies and healthcare systems.
To ensure the project results are taken up and used, the Project-COMFORT team will create an open knowledge hub featuring scientific findings, data, logistical tools and assessment measures on microsampling.
Participants
Show participants on mapUniversities, research organisations, public bodies, non-profit groups
- Aristotelio Panepistimio Thessalonikis, Thessaloniki, Greece
- Fundacio Hospital Universitari Vall D'Hebron - Institut De Recerca, Barcelona, Spain
- Fundacio Institut Universitari Pera La Recerca A L'Atencio Primaria De Salut Jordi Gol I Gurina, Barcelona, Spain
- Fundacio Privada Per A La Recerca I La Docencia Sant Joan De Deu, Esplugues de Llobregat, Spain
- Fundacion Para La Investigacion De Malaga En Biomedicina Y Salud, Malaga, Spain
- Institut Pasteur, Paris, France
- Karolinska Institutet, Stockholm, Sweden
- Region Stockholm, Stockholm, Sweden
- Stichting Sanquin Bloedvoorziening, Amsterdam, Netherlands
- Stichting Vu, Amsterdam, Netherlands
- University Of Dundee, Dundee, United Kingdom
- University Of Newcastle Upon Tyne, Newcastle upon Tyne, United Kingdom
- Univerzita Palackeho V Olomouci, Olomouc, Czechia
Small and medium-sized enterprises (SMEs) and mid-sized companies (<€500 m turnover)
- Capitainer AB, Solna, Sweden
- Collaborate Healthcare- Kainotomes Ypiresies Ygeias Ike, Paiania Attiki, Greece
- Euraxi Pharma, Joue les Tours, France
- European Centre For Clinical Research Training, Bruxelles / Brussel, Belgium
- International Doping Tests Management AB Idtm, Stockholm, Sweden
- Medipace Limited, London, United Kingdom
- Patient Centric Sampling Interest Group Cic, Ware, United Kingdom
- Pharma Quality Europe SRL, Reggello, Italy
- Rhinostics, Inc., Waltham, United States
- Tasso Inc, Seattle, United States
- Thetabiomarkers Ike, Thessaloniki, Greece
- Trajan Scientific Europe LTD, Milton Keynes, United Kingdom
- YourBio Health, Inc., Medford, MA, United States
Third parties
- Hospital Sant Joan De Deu, Esplugues de Llobregat, Spain
- Institut Catala De La Salut, Barcelona, Spain
- Servicio Andaluz De La Salud, Sevilla, Spain
IHI industry partners
- Abbvie Inc, North Chicago Il, United States
- Astrazeneca AB, Sodertaelje, Sweden
- Bayer Aktiengesellschaft, Leverkusen, Germany
- Bayer SpA, Milan, Italy
- Becton Dickinson France SAS, Le Pont De Claix, France
- Eli Lilly And Company, Indianapolis, United States
- Eli Lilly Kinsale Ltd, Cork, Ireland
- F. Hoffmann-La Roche AG, Basel, Switzerland
- Glaxosmithkline Biologicals SA, Rixensart, Belgium
- Glaxosmithkline Research & Development Limited, London, United Kingdom
- Institut De Recherches Internationales Servier, Gif-Sur-Yvette, France
- Institut De Recherches Servier, Gif-Sur-Yvette, France
- Iqvia Solutions Belgium, Zaventem, Belgium
- Janssen Pharmaceutica Nv, Beerse, Belgium
- Labcorp Early Development Laboratories Limited, Harrogate, United Kingdom
- Lilly Deutschland GmbH, Bad Homburg, Germany
- Novartis Pharma AG, Basel, Switzerland
- Pfizer Inc, New York City, United States
- Pfizer Limited, Sandwich, United Kingdom
- Pfizer R&D UK Limited, Sandwich, United Kingdom
- Roche Diagnostics International AG, Rotkreuz, Switzerland
- Siemens Healthineers AG, Forchheim, Germany
- Technologie Servier, Orleans, France
Contributing partners
- Jones Lang Lasalle Se, Frankfurt Am Main, Germany
- Miebach Consulting GMBH, Frankfurt am Main, Germany
Participants | |
---|---|
Name | EU funding in € |
Aristotelio Panepistimio Thessalonikis | 46 343 |
Capitainer AB | 32 740 |
Collaborate Healthcare- Kainotomes Ypiresies Ygeias Ike | 155 949 |
Euraxi Pharma | 23 714 |
European Centre For Clinical Research Training | 137 666 |
Fundacio Hospital Universitari Vall D'Hebron - Institut De Recerca | 288 263 |
Fundacio Institut Universitari Pera La Recerca A L'Atencio Primaria De Salut Jordi Gol I Gurina | 153 521 |
Fundacio Privada Per A La Recerca I La Docencia Sant Joan De Deu | 387 365 |
Fundacion Para La Investigacion De Malaga En Biomedicina Y Salud | 180 093 |
Institut Pasteur | 77 221 |
International Doping Tests Management AB Idtm | 16 240 |
Karolinska Institutet | 179 661 |
Pharma Quality Europe SRL | 168 290 |
Region Stockholm | 349 249 |
Stichting Sanquin Bloedvoorziening | 64 648 |
Stichting Vu | 177 580 |
Thetabiomarkers Ike | 10 853 |
Univerzita Palackeho V Olomouci | 324 526 |
Third parties | |
Name | Funding in € |
Hospital Sant Joan De Deu | 60 211 |
Institut Catala De La Salut | 149 296 |
Servicio Andaluz De La Salud | 55 278 |
Total Cost | 3 038 707 |