Trials@Home

Clinical trials increase in size, complexity and costs. This is fuelled with the need to demonstrate effects in more complex therapeutic areas, and to detect subgroups with different benefit and safety responses. Complexities, rigid clinical control, physical distance and (perceived) burden put patient engagement under pressure. Slow recruitment and retention compromise efficiency, generalisability and validity of traditional, site-centred trials. Remote Decentralized Clinical Trials (RDCTs) and hybrid approaches address these challenges. RDCTs are an operational strategy for technology-enhanced clinical trials, which enable (semi-)continuous data collection and real-world evidence generation, increase patient recruitment and retention and decrease patient and investigator burden and costs. Trials brought to the home of patients. Paradigmatic changes in EU clinical trial design are required to fully benefit from the digital era. Yet, the feasibility of running RDCTs needs to be rigorously demonstrated together with guidance and support measures for their execution. The overall goal of Trials@Home is to reshape clinical trial design, conduct and operations, by developing and piloting standards, recommendations and tools for the definition and operationalisation of remote decentralised clinical trials (RDCTs) in Europe. Trials@Home brings together a very strong consortium and will reshape clinical trial design, conduct and operations, by analysing, developing and piloting standards, recommendations and tools to define and operationalize RDCTs. Trials@Home will design and run a pan-European RDCT pilot based on: a. best practices of trials with RDCT elements, b. assessment of latest technological tools, c. the regulatory and ethical framework and potential changes required to facilitate RDCTs and d. stakeholder perspectives on the change from classical RCTs to RDCTs with strong patient involvement. The results of these assessments and the pilot will drive the formulation and dissemination of recommendations and tools for the implementation of RDCTs in Europe with the ultimate goal to improve the speed, quality and efficiency of clinical trials, and improving patients’ access to innovative treatment strategies.

CERTH-ITI is participating in WP1 and WP2 and its main objectives are: 1) to scan for and identify a wide range of potential technologies and technological solutions (i.e., software packages that implement certain technologies) that support RDCT, either available as marketed products or as a validated proof-of-concepts, 2) to perform a quality assessment and prioritisation of the identified technological solutions, including evaluation of technologies available as proof-of-concept not validated specifically for use in clinical trials, 3) to develop recommendations for evaluated technological solutions, 4) to refine these recommendations, and select and tailor the appropriate technology package for the WP3 pan-EU pilot RDCT, based on chosen therapeutic areas and study protocol and 5) to provide technical support for the training in, and use of the resulting composition platform to those parties involved in the clinical trial.

Consortium

Universitair Medisch Centrum Utrecht (UMCU) NL
JCR Clinical Research b.v. (JCR) NL
Stichting Lygature (Lygature) NL
The Chancellor, Masters and Scholars of the University of Oxford (UOXF) UK
FH JOANNEUM Gesellschaft MBH (JOANNEUM) AT
Medical Research Network Limited (MRN) UK
eClinicalHealth Ltd. (eClinicalHealth) UK
University of Dundee (UNIVDUN) UK
Syddansk Universitet (SDU) DK
Fundacion Para el Formento de la Investigation Sanitaria y Biomdica de la Comunitat Valenciana (FISABIO) ES
Ethniko Kentro Erevnas Kai Technologikis Anaptyxis (CERTH) GR
Vital Transformation (VT) BE
Stichting MLC Foundation (MLCF) NL
Federation Internationale du Diabetes region Europe AISBL (IDF Europe) BE
Stichting United Parent Projects Muscular Dystrophy (UPPMD) NL
DREEM (RYTHM) FR
Universiteit Utrecht (UU) NL
Sanofi-Aventis Recherche & Developpement (SARD) FR
Allergan Sales Ilc (Allergan) US
AstraZeneca AB (AZ) SE
Bayer Aktiengesellschaft (Bayer) GE
Boehringer – Ingelheim Pharma GMBH & CO KG (BI Pharma) GE
Covance Clinical and Periapproval Services SA (Covance) BE
IQVIA (IQVIA) FR
Janssen Pharmaceutica NV (Janssen) BE
JDRF International (JDRF) US
Medtronic International Trading SARL (Medtronic) CH
Nokia Bell (Nokia Bell) BE
Novartis Pharma AG (Novartis) CH
Pfizer Limited (Pfizer) UK
Takeda Development Centre Europe LTD. (Takeda) UK
TEVA Pharmaceutical Industries Limited (TEVA) IL
UCB Biopharma SPRL (UCB) BE