Trials@Home

Center of excellence – remote decentralised clinical trials

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

Clinical trials without the clinic. What have we learned so far?

New technology – and COVID – have caused an uptick in the use of remote decentralised clinical trials (RDCTs), in which digital and other innovations shift activities that usually take place at a hospital or clinic to a participant's home or other more local setting. IMI project Trials@home interviewed 48 people involved in RDCTs, to find out what works, and what doesn’t.###

The general conclusion is that some things, like recruitment, are made easier by remote trials. One woman participating in a fully remote trial explained how she appreciated how easy it was to fit into her routine. Gathering data from multiple sources can also contribute to data completeness. However, many interviewees on the trial management side mentioned that it can be a challenge to keep participants engaged in trial activities. Other concerns raised include the question of whether RDCTs may transfer the work onto participants and remote staff, while technology does not always function as anticipated.

‘RDCTs will continue to face challenges in implementing novel technologies,’ the authors conclude. ‘However, maximising patient and partner involvement, reducing participant and staff burden, and simplifying how participants and staff interact with the RDCT may facilitate their implementation.’

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

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.

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Participants

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EFPIA companies
  • Allergan Limited, Marlow, United Kingdom
  • Astrazeneca AB, Södertälje, Sweden
  • Bayer Aktiengesellschaft, Leverkusen, Germany
  • Boehringer Ingelheim Internationalgmbh, Ingelheim, Germany
  • Iqvia Rds France, Saint-Ouen, France
  • Janssen Pharmaceutica Nv, Beerse, Belgium
  • Labcorp Clinical Development, Woluwe-Saint-Lambert, Belgium
  • Medtronic International Trading SARL, Tolochenaz, Switzerland
  • Merck Kommanditgesellschaft Auf Aktien, Darmstadt, Germany
  • Novartis Pharma AG, Basel, Switzerland
  • Pfizer Limited, Sandwich, Kent , United Kingdom
  • Sanofi-Aventis Recherche & Developpement, Chilly Mazarin, France
  • Takeda Pharmaceuticals International AG, Glattpark-Opfikon (Zurich), Switzerland
  • Teva Pharmaceutical Industries Limited, Netanya, Israel
  • UCB Biopharma, 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
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

Participants
NameIHI funding in €
Dreem260 000
Eclinicalhealth LTD1 110 000
Ethniko Kentro Erevnas Kai Technologikis Anaptyxis403 750
Federation Internationale Du Diabete Region Europe Aisbl198 548
Fh Joanneum Gesellschaft Mbh879 625
Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana400 675
Julius Clinical Research BV3 413 815
Medical Research Network Limited709 802
Stichting Lygature181 228
Stichting Mlc Foundation198 750
Stichting United Parent Projects Muscular Dystrophy530 275
Syddansk Universitet110 313
Universitair Medisch Centrum Utrecht7 836 195
Universiteit Utrecht784 505
University Of Dundee1 445 598
University of Oxford (left the project)5 165
Vital Transformation568 755
Total Cost19 036 999