Project-COMFORT

Patient-centric blood sampling for improved healthcare (Project-COMFORT)

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

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Universities, 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
NameEU funding in €
Aristotelio Panepistimio Thessalonikis46 343
Capitainer AB32 740
Collaborate Healthcare- Kainotomes Ypiresies Ygeias Ike155 949
Euraxi Pharma23 714
European Centre For Clinical Research Training137 666
Fundacio Hospital Universitari Vall D'Hebron - Institut De Recerca288 263
Fundacio Institut Universitari Pera La Recerca A L'Atencio Primaria De Salut Jordi Gol I Gurina153 521
Fundacio Privada Per A La Recerca I La Docencia Sant Joan De Deu387 365
Fundacion Para La Investigacion De Malaga En Biomedicina Y Salud180 093
Institut Pasteur77 221
International Doping Tests Management AB Idtm16 240
Karolinska Institutet179 661
Pharma Quality Europe SRL168 290
Region Stockholm349 249
Stichting Sanquin Bloedvoorziening64 648
Stichting Vu177 580
Thetabiomarkers Ike10 853
Univerzita Palackeho V Olomouci324 526
 
Third parties
NameFunding in €
Hospital Sant Joan De Deu60 211
Institut Catala De La Salut149 296
Servicio Andaluz De La Salud55 278
 
Total Cost3 038 707