Periodic Reporting for period 4 - Trials@Home (Trials@Home: Center of Excellence – Remote Decentralised Clinical Trials)
Berichtszeitraum: 2022-09-01 bis 2023-08-31
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.
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. During the fourth year, the Trials@Home consortium has continued its interactions with several relevant stakeholder groups, including the EMA Accelerating Clinical Trials in the EU (ACT EU) programme and the EPFIA ICH-E6 subgroup while creating new interactions with new stakeholder groups for sustainability purposes.
This year was essentially focused on the “go live” of the RADIAL study which recruited its first participant during the third quarter of 2023 (22nd of August 2023). RADIAL is a European proof-of-concept study aiming to assess the scientific quality and operational feasibility of fully decentralized and hybrid approaches in comparison with traditional, site-based trials. RADIAL will evaluate the acceptability of DCTs in terms of safety, data quality and medical endpoints, as well as explore potential benefits to DCT approaches. The first half of this fourth year was essential to get ethical and regulatory approval for RADIAL. The RADIAL study was submitted for regulatory approval via CTIS and separately for UK. The final approval of part II in all 5 EU countries was obtained in November 2022.
Meanwhile the technology package for RADIAL was assembled and tested including a technology support system to provide adequate support to all RADIAL contributors. The helpdesk system provides manuals in a knowledge base with additional information and allows to request information from experts. Processes were established around the delivery of the study medications and study materials to the patient, and samples from the patient to central laboratory facilities.
The consortium developed site training materials and patient-facing training materials supported by the communication team and the Patient Expert Panel in creating patient flows, site staff flows, and supporting the RADIAL website setup. These also supplement DCT knowledge in general.
In addition, other research activities continued, such as the ongoing programme of updating interviews on case studies and performing interviews on several new case studies of interest regarding decentralised clinical trials.
All these activities generated valuable DCT knowledge, which led to the publication of 11 scientific articles as well as public deliverables which are all available via trialsathome.com.
This year was essentially focused on the “go live” of the RADIAL study which recruited its first participant during the third quarter of 2023 (22nd of August 2023). RADIAL is a European proof-of-concept study aiming to assess the scientific quality and operational feasibility of fully decentralized and hybrid approaches in comparison with traditional, site-based trials. RADIAL will evaluate the acceptability of DCTs in terms of safety, data quality and medical endpoints, as well as explore potential benefits to DCT approaches. The first half of this fourth year was essential to get ethical and regulatory approval for RADIAL. The RADIAL study was submitted for regulatory approval via CTIS and separately for UK. The final approval of part II in all 5 EU countries was obtained in November 2022.
Meanwhile the technology package for RADIAL was assembled and tested including a technology support system to provide adequate support to all RADIAL contributors. The helpdesk system provides manuals in a knowledge base with additional information and allows to request information from experts. Processes were established around the delivery of the study medications and study materials to the patient, and samples from the patient to central laboratory facilities.
The consortium developed site training materials and patient-facing training materials supported by the communication team and the Patient Expert Panel in creating patient flows, site staff flows, and supporting the RADIAL website setup. These also supplement DCT knowledge in general.
In addition, other research activities continued, such as the ongoing programme of updating interviews on case studies and performing interviews on several new case studies of interest regarding decentralised clinical trials.
All these activities generated valuable DCT knowledge, which led to the publication of 11 scientific articles as well as public deliverables which are all available via trialsathome.com.
The Trials@Home initiative is a key initiative where new thinking, cross-industry alignment and solid research on DCT approaches takes place to inform and innovate within the DCT field in Europe. The research performed so far formed the basis for 11 publications in prominent peer reviewed journals. The three articles published in RP4 address a wide breadth of DCT approaches: consensus on terminology used to describe DCTs, stakeholder experiences, and the methods used to conduct DCTs. These research questions were addressed through a variety of methodologies, including semi-structured interviews, a systematic literature review, and a multiple-choice survey.
Beyond these publication efforts, the Trials@Home consortium is also actively involved in discussions around DCT approaches, with consortium members participating in 78 different conferences throughout the project (27 in year 4 alone) to report on the impact of Trials@Home.
The final Trials@Home DCT recommendations will be published at the end of the project. With further expected developments in technology and trials methods, the expertise and impact will develop significantly over the next few years. More scientific papers are expected as well, which are now in various stages of development from the idea phase to manuscript preparation.
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.
Beyond these publication efforts, the Trials@Home consortium is also actively involved in discussions around DCT approaches, with consortium members participating in 78 different conferences throughout the project (27 in year 4 alone) to report on the impact of Trials@Home.
The final Trials@Home DCT recommendations will be published at the end of the project. With further expected developments in technology and trials methods, the expertise and impact will develop significantly over the next few years. More scientific papers are expected as well, which are now in various stages of development from the idea phase to manuscript preparation.
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.