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

Periodic Reporting for period 1 - Trials@Home (Trials@Home: Center of Excellence – Remote Decentralised Clinical Trials)

Reporting period: 2019-09-01 to 2020-08-31

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

The Remote decentralised clinical trials (RDCT) approach is an operational strategy for technology-enhanced clinical trials, that are more accessible to patients by moving clinical trial activities to more local settings. Since this reduces the time spent attending study sites, RDCTs have the potential to make parting in clinical trials simple and 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 RDCTs 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 RDCTs across Europe and worldwide.
in year 1, WP1 analysed prior and ongoing experiences with RDCTs to provide best practices, selection criteria and recommendations for implementation into the Trials@Home pan-EU pilot study. The draft recommendations are based on in-depth research into RDCT methods, and can be found on the website: https://trialsathome.com. They apply to all aspects of RDCTs from design, planning and set-up to close-out and reporting. Key recommendations are:
o Answer an important research question
o Keep the focus on participants
o Simplify the participant experience whilst maintaining quality and scientific rigour

WP2 TECH will provide a technology package recommendation for the pan-EU pilot study. generate recommendations for future RDCTs regarding technology selection. To get an overview of existing technologies, WP2 performed an intensive technology scan, concluded by an external and internal RFI. WP2 established quality criteria and a process along which the identified solutions can be assessed. Two internal technologies suitable for basis technology solutions were assessed in an intensive process.
Furthermore, to identify stakeholder needs and to extract actionable design insights, WP2 organized Design Thinking panels with user stakeholders representing study participants and decentralized site team staff. To link terminologies used in the RDCTs,Trials@Home also published a Glossary which provides updated definitions of already used terms in clinical trials as well as new terms, specific for RDCTs.

In the first year, WP3 PILOT has assessed several aspects for the pan-EU pilot study. Through this study, they will comparatively analyse the components (traditional clinical trial and hybrid and/or fully RDCT) and present and refine key performance indicators to qualify and quantify the flow of activities, subject perception, cost, quality and compliance. WP3 has come to an endorsed recommendation to choose diabetes as therapeutic area for the pilot study. Furthermore, a recommendation for the study design, IMP, and study population has been made.

As part of Trials@Home, the regulatory, ethical, GCP and legal aspects of the current EU environment relevant to RDCTs will be assessed and innovated where possible. To achieve this, WP4 EAGLE has mapped five EU Member States, and information is currently being gathered for six more. Besides this, WP4 aims to gain insight in the current experience and the real challenges that researchers encounter in the design, conduct and reporting of RDCTs. To achieve this, a semi-structured questionnaire was developed.
With regard to the pandemic, WP4 has initiated a dedicated study on top of the initial objectives, that assesses regulatory actions and flexibility which have been implemented due to COVID-19. The results of this study will not only provide insight into the evolving landscape but also allow for evaluating if COVID-19 has pushed the needle forward when it regards RDCTs.

WP5 CODE has created and distributed a communications plan and a style guide with the necessary templates for all the project partners to use. In addition, WP5 created a new logo and further branding elements for the project. Based on those, a publicly available project website was created, highlighting the aims of the project, its partners, its objectives and deliverables per WP. It also houses all project updates, public webinars, and completed deliverables. Through the website people can also register to newsletter and thus receive webinar invitations and project updates. There is a big uptake from internal project partners and external stakeholders in registering for the newsletter. WP5 also created a twitter account. The account is used to promote project outcomes and to back up other communication efforts to promote upcoming activities where external stakeholders can participate.

WP6 PROMS focuses on the project management within Trials@Home, thereby facilitating timely delivery of all activities, within budget and in compliance with the EC guidelines. During the first year of the project, WP6 has set up a strong governance structure for the project, established a sound and reliable resources management system, as well as strong internal communication system. The first version of the Data Management Plan has been drafted and the External Stakeholder Platform (ESP) has been established. Ongoing activities include managing the ESP, coordinating the preparation of open call for additional technology partners, and preparing the first draft of the sustainability plan.
The glossary publication is a significant result from Trials@Home: https://trialsathome.com/trialshome-glossary/. The publication brings together and clarifies the language used about RDCTs. Multiple external glossary sources were analysed for this work, gaps and conflicts were resolved and resulted in re-defining some terms and introducing new ones where necessary. The Trials@Home glossary work is already being used by other stakeholders in the industry.

The Basic Building Block (BBB) structure created within WP2 TECH has been taken up by other work packages as the common unifying framework to connect the different work content. The BBB framework could be a very practical mechanism to consider the best practices, technological approaches and stakeholder involvement in the conduct of RDCTs and the team is hopeful that this model will see broader adoption in the industry once it will be disseminated more broadly by the Trials@Home team.

The Trials@Home WP team has also been active in external communications activities, coordinating and participating in dedicated Trials@Home panels and discussions in key industry events (Eyeforpharma Europe, Clinical Trials Europe, eClinical Forum, etc.). The Trials@Home initiative is starting to be seen as a key initiative where new thinking and cross-industry alignment is starting to emerge to advance the RDCT field forward in Europe.
The final Trials@Home RDCT recommendations will be published in 2024. With further expected developments in technology and trials methods, we anticipate that expertise will develop significantly over the next few years.