Trials@Home

Center of excellence – remote decentralised clinical trials
Trials@Home logo

FACTS & FIGURES

Start Date
End Date
Call
IMI2 - Call 14
Grant agreement number
831458

Type of Action: 
RIA (Research and Innovation Action)

Contributions
IMI Funding
19 036 998
EFPIA in kind
19 248 295
Other
45 977
Total Cost
38 331 270

Summary

In a conventional clinical trial, patients have to make regular trips to the clinic for check-ups to monitor their condition. Many patients are understandably put off by the distance to the clinic and how often they would be expected to make the trip, and many patients who initially join trials drop out for logistics reasons. Digital technologies and wearable devices mean it is now possible to assess patients remotely – while they are at home, or going about their daily lives. If used during clinical trials, they could dramatically reduce the number of times patients are expected to visit the clinic.

Trials@Home aims to explore the potential of digital technologies for use in ‘remote decentralised clinical trials’ (RDCTs). They will develop and test methods to streamline data collection as well as patient recruitment and retention. They will also discuss RDCTs with patients as well as regulators, payers, health technology assessment bodies (HTAs) and ethics bodies, to ensure that the project outcomes can be implemented. At the heart of the project is a study in which one group of patients will have the conventional clinical trial experience with regular clinic visits; a second group of patients will participate completely remotely; and a third group will follow a partly conventional / partly RDCT approach. The project will use the results of this study to identify which approaches are best for patient satisfaction, data quality and other parameters.

If successful, RDCTs could make it easier to recruit and retain larger numbers of patients, including people from groups that are often under-represented in trials. Furthermore, as data collection would be more or less continuous, the results would be more reliable and more representative of the real world.

Achievements & News

Unravelling the enigma of autoimmune diseases – an opinion piece by Pierre Meulien
June 2020

We like to think of the immune system as a surveillance mechanism for the body that’s standing guard, ready to weed out and kill anything harmful. But for people with an autoimmune disorder, it doesn’t work that way; deregulated, it fights our own tissue instead of protecting it. ###And while we might have some success in treating the symptoms, we are largely in the dark as to why treatments work for some and not for others, as well as what triggers the disease in the first place. In an opinion piece published on the IMI website, IMI Executive Director Pierre Meulien explores IMI’s portfolio in this important disease area.

‘One of things that IMI is particularly proud of is the progress we’ve made in the reclassification of subtypes of disease, which means redefining diseases based on their biology and not just symptoms,’ he writes. ‘It’s an extremely scientifically complex area, and we’re steadily increasing the level of understanding of the molecular drivers in a number of disease areas.’

IMI is also very active in remote assessment. ‘This tech convergence is a trend, and we will see more and more sophisticated remote monitoring which will change the game in clinical trials,’ writes Dr Meulien, citing IMI’s Trials@Home and IDEA-FAST projects.

Find out more

Participants Show participants on map

EFPIA companies
  • Allergan Limited, Marlow, United Kingdom
  • Astrazeneca AB, Södertälje, Sweden
  • Bayer Aktiengesellschaft, Leverkusen, Germany
  • Boehringer Ingelheim Internationalgmbh, Ingelheim, Germany
  • Covance Clinical And Periapproval Services, Woluwe-Saint-Lambert, Belgium
  • Iqvia Rds France, Saint-Ouen, France
  • Janssen Pharmaceutica Nv, Beerse, Belgium
  • Medtronic International Trading SARL, Tolochenaz, Switzerland
  • Novartis Pharma AG, Basel, Switzerland
  • Pfizer Limited, Sandwich, Kent , United Kingdom
  • Sanofi-Aventis Recherche & Developpement, Chilly Mazarin, France
  • Takeda Development Centre Europe LTD, London, United Kingdom
  • Teva Pharmaceutical Industries Limited, Netanya, Israel
  • UCB Biopharma SRL, Brussels, Belgium
Universities, research organisations, public bodies, non-profit groups
  • Ethniko Kentro Erevnas Kai Technologikis Anaptyxis, Thermi Thessaloniki, Greece
  • Fh Joanneum Gesellschaft Mbh, Graz, Austria
  • Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana, Valencia, Spain
  • Syddansk Universitet, Odense, Denmark
  • Universitair Medisch Centrum Utrecht, Utrecht, Netherlands
  • Universiteit Utrecht, Utrecht, Netherlands
  • University Of Dundee, Dundee, United Kingdom
  • University of Oxford, Oxford, United Kingdom
Small and medium-sized enterprises (SMEs) and mid-sized companies (<€500 m turnover)
  • Dreem, Paris, France
  • Eclinicalhealth LTD, Stirling, United Kingdom
  • Julius Clinical Research BV, Zeist, Netherlands
  • Medical Research Network Limited, Milton Keynes, United Kingdom
  • Stichting Lygature, Utrecht, Netherlands
  • Stichting Mlc Foundation, Den Haag, Netherlands
  • Vital Transformation, Wezembeek Oppem, Belgium
Patient organisations
  • Federation Internationale Du Diabete Region Europe Aisbl, Brussels, Belgium
  • Stichting United Parent Projects Muscular Dystrophy, Veenendaal, Netherlands
Project coordinator
Diederick Grobbee
Universitair Medisch Centrum Utrecht