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Trials@Home: Center of Excellence – Remote Decentralised Clinical Trials

Periodic Reporting for period 3 - Trials@Home (Trials@Home: Center of Excellence – Remote Decentralised Clinical Trials)

Reporting period: 2021-09-01 to 2022-08-31

Clinical trials are crucial in drug development and improving patient health. However, they traditionally require participants to attend F2F study visits at clinical sites. While these trials produce valid results, they can bring a significant burden to participants and risk excluding people who are unable or unwilling to travel for study visits. (S)low patient recruitment and low retention put pressure on the efficiency, generalisability, and validity of traditional, clinical site-centred trials.

Decentralised clinical trial (DCT) approaches hold the promise of solving this problem. The DCT approach is an operational strategy for technology-enhanced clinical trials, which are more accessible to patients by moving clinical trial activities to more local settings. Since this reduces the time spent attending study sites, DCTs have the potential to make taking part in a clinical trial more convenient.

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 DCT approaches in Europe. By working together to share knowledge and experience, this consortium of public and private partners aims to improve the understanding and delivery of DCT approaches across Europe and worldwide.
Trials@Home follows a co-creative multi-stakeholder approach where academic partners, Small and Medium-sized Enterprises (SMEs), private foundations, and EFPIA partners work together with other stakeholders from across the medical, technological, regulatory, ethical, and social aspects of DCTs with the common goal to develop concrete and practical recommendations, and pilot tools supporting widespread acceptance and suitable use of DCT approaches in Europe.

The DCT field is a highly dynamic innovative field in which concepts and terminology have been evolving over the last several years. In such environment, Trials@Home has been actively engaged in that evolution, including discussions with regulators, Non for Profit Organisations (DTRA, CTTI), investigators, technology developers, and HTA organisations. So far, this has led to the publications of nine of the project's public deliverables as well as seven scientific articles, which are all available via trialsathome.com.

After obtaining insights from case studies and having designed integration and interoperability recommendations, which can already serve as blueprint for DCT architectures, the team has assembled all technical components for the RADIAL proof-of-concept study and has started a series of testing.
In the meantime, after having set up the RADIAL study as a parallel-group, open-label, multicentre study in Europe, which evaluates the scientific and operational quality of fully decentralised and hybrid approaches and evaluates the feasibility of such approaches compared to a conventional trial approach, the RADIAL study was submitted for regulatory approval via EMA CTIS at the end of the first quarter 2022 in five member states, namely Spain, Italy, Germany, Denmark and Poland and to ethics on third quarter 2022. CTIS I approval was obtained. RADIAL study has also been submitted for regulatory notification and ethical approval in the United Kingdom. The First Patient First Visit-milestone is expected for the end of the year or early 2023.

Overall training modules for DCT approaches are in development, based on surveys to patients, PIs, and GPs to identify their needs for training. In terms of project management, team has followed the strong governance structure that was set up for the project, including a Scientific Advisory Board, External Stakeholder Platform, and Patient Expert Panel and has reinforced collaboration with other groups.
The research performed so far formed the basis for seven publications in prominent peer reviewed journals which can be accessed via https://trialsathome.com/peer-reviews-and-research-outputs/. The articles address many different aspects of DCT approaches: DCT methods, DCT activities reported in clinical trial protocols, and learnings from DCT experiences, as well as recruitment, retention, and adherence in DCTs. Another important topic is the emerging regulatory guidance in light of COVID-19 and the early impact of the pandemic on the uptake of DCT methods. In addition, ethical aspects of DCTs and the regulatory perspective on opportunity and challenges for DCTs in the EU are discussed.

In addition, consortium members have presented insights from Trials@Home at more than 50 occasions including e.g. webinars and conferences. The Trials@Home initiative is continuing to be seen as a key initiative where new thinking and cross-industry alignment is starting to emerge to advance the DCT field forward in Europe.

The Trials@Home consortium engaged with EMA’s ITF, the German BfArM, and multiple IRBs on RADIAL design. The interaction was successful and there was significant interest in the topic of DCTs, as demonstrated by 70+ participants from EMA’s side. The ITF group included 43 regulators from more than 15 National Competent Authorities from across Europe, which reflected the great interest in DCTs. Besides providing input in the protocol development, these meetings pave the way for DCTs in general and influence the landscape of DCTs.

In addition, the glossary work on the language used for DCT is still ongoing and is available: https://trialsathome.com/trialshome-glossary/. This work is pushed beyond project boundaries and collaboration around terms harmonisation are ongoing with organisations such as DTRA and CTTI.

The final Trials@Home DCT recommendations will be published in 2024. With further expected developments in technology and trials methods, the expertise will develop significantly over the next few years.
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