Objectives and key deliverables
The six Work Packages (WPs) of Trials@Home and their interdependencies.
1. Best practices in DCT’S
WP1 BEST has three objectives:
- To collect and analyse prior and ongoing experiences with DCTs;
- To provide best practices, selection criteria and recommendations for implementation into the WP3 PILOT.
- To provide updates to final recommendations based on ongoing case studies conducted in parallel to the pilot.
Deliverables |
Timeline |
Status |
|---|---|---|
| D1.1 First set of recommendations for DCTs (to be implemented in the pan-EU pilot DCT) |
M12 | Completed |
| D1.2 Criteria for selection of appropriate trials |
M12 | Completed |
| D1.3 Updated of recommendations based on ongoing case studies running in parallel to the WP3 pilot |
M54 | Ongoing |
2. Technologies – barries, enablers and data management
WP2 TECH has the following objectives:
- To scan for and identify a wide range of potential technologies and technological solutions (i.e., software packages that implement certain technologies) that support DCT, either available as marketed products or as a validated proof-of-concepts.
- 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.
- To develop recommendations for evaluated technological solutions.
- To refine these recommendations, and select and tailor the appropriate technology package for the WP3 pan-EU pilot DCT, based on chosen therapeutic areas and study protocol.
- To design, assemble and test the infrastructure for the selected technology package for the WP3 pan-EU pilot DCT.
- To provide technical support for the training in, and use of the resulting composition platform to those parties involved in the clinical trial.
- To define data quality, management, communication, and activity flows.
Deliverables |
Timeline |
Status |
|---|---|---|
| D2.1 Glossary of terms and definitions used within WP2 (task 2.1.1) |
M6 | Completed |
| D2.2 Detailed list of quality assessment criteria and assessment procedures (task 2.1.2) |
M12 | Completed |
| D2.3 Technology scan: list of technologies suitable for RDCTs for each of the building blocks of an RDCT to be used in the quality assessment (task 2.1.1) |
M12 | Completed |
| D2.4 Technology package for the pan-EU pilot study including data flows and connections with external systems where necessary (task 2.3) |
M17 | Completed |
| D2.5 Pilot data management plan and operational database connected with the central platform and other systems tailored to the needs of the pan-EU pilot and with data export suitable for statistical analysis (task 2.4) |
M28 | Ongoing (Preliminary work being done as part of D6.3) |
| D2.6 An interconnected, fully tested technology platform that connects the technological solutions chosen for the technology package and supports the WP3 pan-EU Pilot (task 2.5) |
M30 | Not started |
| D2.7 Technology support system (task 2.6) |
M32 | Not started |
| D2.8 Updated summary and detailed report with recommendations for integrated technologies to be used in RDCT and hybrid approaches, based on pilot findings (task 2.7) |
M54 | Not started |
3. Pan-EU RDCT pilot
WP3 PILOT has the following objectives:
- To design, set-up and run a pan-EU pilot, comparing traditional clinical trial approaches to fully and hybrid DCT approaches.
- To comparatively analyse the components (traditional clinical trial and hybrid and/or fully DCT) in the pan-EU pilot and present and refine key performance indicators (KPIs) to qualify and quantify the flow of activities, subject perception, cost, quality and compliance.
Deliverables |
Timeline |
Status |
|---|---|---|
| D3.1 Report on decisions and rationale for these decisions on pivotal choices regarding pan-EU pilot (TA(s), N of arms, intervention, countries, including rationale for choices made |
M20 | Completed (confidential) |
| D3.2 Finalised list of KPI’s to be used to qualify and quantify the flow of activities in the pilot |
M20 | Completed |
| D3.3 Draft protocol for pan-EU pilot to be used for small feasibility (dry-run) study ready and aligned across countries |
M22 | Completed |
| D3.4 Report on small feasibility study & proposed adaptations to the protocol to be made based on results & final protocol(s) for pan-EU pilot |
M25 | Not started |
| D3.5 First study subject approvals package |
M31 | Not started |
| D3.6 Midterm recruitment report |
M35 | Not started |
| D3.7 Audit report on process and ICH GCP deviations for the pan-EU pilot |
M48 | Not started |
| D3.8 Report on final evaluation of the Pan-EU pilot regarding KPI and learnings |
M54 | Not started |
| D3.9 Report on status of posting results |
M56 | Not started |
| D3.10 Ethics D2, H. Requirement No 2: pre-feasibility information package ready |
M22 | Not started |
| D3.11 Ethics D3, HCT – Requirement: human cells/tissues information package |
M22 | Not started |
| D3.12 Ethics D5, NEC – Requirement: non-EU activities |
M22 | Not started |
| D3.13 Ethics D6 – H – requirement No. 6 |
M22 | Not started |
4. Ethical, regulAtory, Gcp and LEgal aspects
WP4 EAGLE. The general objective of this WP is to assess and innovate the regulatory, ethical, GCP and legal aspects of the current EU environment relevant to DCTs. To achieve this, EAGLE will:
- Map and analyse the ethical, regulatory, GCP and legal aspects (regulations and guidelines) of the current EU environment for DCT
- Identify challenges and solutions for the evolution of DCT within the clinical regulatory framework, including digital health.
- Analyse the acceptability of the DCT approach for benefit-risk decision making by regulators and HTA bodies.
- Develop an innovative proposal to create a responsible and sustainable ethical and regulatory ecosystem for DCT.
Deliverables |
Timeline |
Status |
|---|---|---|
| D4.1 Map of the EU legislation on DCTs including legal, regulatory, ethical and stakeholder recommendations for conduct of the pan-EU pilot |
M18 | Completed |
| D4.2 SWOT analysis of ethical, legal and operational barriers and enablers for DCT in the EU |
M48 | Ongoing |
| D4.3 Overview of technical and regulatory implications of DCTs for efficient regulatory decision-making |
M48 | Ongoing |
| D4.4 Overview of innovative scenarios for a responsible and sustainable DCT ecosystem |
M48 | Ongoing |
| D4.5 Final EAGLE report |
M54 | Not Started |
5. Communication, dissemination & stake-holder engagement
WP5 CODE aimes to:
- To communicate to external and internal stakeholders the key results of the project, and develop a broad consensus on how DCTs should be developed and implemented in the EU.
- To identify stakeholders’ perspectives on the barriers and enablers in DCTs (patients, regulatory agencies, ethics committees, principal investigators, study coordinators, hospitals, pharmaceutical companies) and communicate these perspectives both externally and internally.
- To measure and quantify the paradigm change from traditional trial approaches to induced changes in DCTs from the perspectives of patients and HCPs.
- To assess and tailor the related services of the ‘technology package’ resulting from WP2 TECH for the communication activities.
- To develop a check-list on best practices for setting-up a DCT in EU in consultation with the External Stakeholder Platform (ESP) and internal stakeholders, including a digital HCP researcher certification programme.
- To develop training kits for deploying pan-EU DCTs for principal investigators, HCPs, patients, inspectors, pharmaceutical companies, clinical research organisations; provide a platform for their effective dissemination and promotion; create informational materials to clarify DCTs for prospective trial participants; and develop site support materials that specifically aid in the execution of an RDCT.
- To run virtual education/information sessions for company providers/developers of technologies to be deployed for DCTs.
Deliverables |
Timeline |
Status |
|---|---|---|
| D5.1 Communication and Dissemination Plan |
M3 | Completed |
| D5.2 Trials@Home website, templates, and social media tools |
M1 | Completed |
| D5.3 Report on the mapping of paradigm changes in the relationships between HCPs and patients |
M18 | Ongoing |
| D5.4 Report on changing stakeholders’ roles and responsibilities and proposals from stakeholders to overcome any challenges |
M24 | Ongoing |
| D5.5 Education & Training Sessions |
M60 | Ongoing |
| D5.6 Set of tools for DCT including training materials for stakeholders (e.g., principal investigators, patients, regulatory representatives and inspectors, etc.), and contract templates for DCT |
M54 | Not started |
6. PROject Management and Synthesis
WP6 PROMS will:
- Provide effective project management to all workpackages facilitating timely delivery of all actitivities, within budget and in compliance with the EC Grant Agreement and Consortium Agreement
- Set-up an effective internal communication infrastructure and foster the integrative process within the consortium
- Set-up and manage the External Stakeholder Platform, including liaising with the other WPs and set-up and coordination of the required ESP meetings (operationally, content development within the WPs)
- Plan for, organise and coordinate an open call for additional technology partners
- Develop a sustainability plan for optimal translation and implementation of project results within and beyond the project duration
- Prepare, coordinate and develop an integrated set of recommendations, draft EU guidelines and (educational) tools, synthesized from the outcomes of WP1-5 to facilitate DCT implementation in Europe
Deliverables |
Timeline |
Status |
|---|---|---|
| D6.1 ESP Terms of Reference |
M2 | Completed |
| D6.2 Project management manual and templates |
M6 | Completed |
| D6.3 First version of Data management plan |
M6 | Completed |
| D6.4 First version of sustainability plan |
M14 | Completed |
| D6.5 Open call for additional technology partners |
M12 | Completed |
| D6.6 Final version of sustainability plan |
M60 | Ongoing |
| D6.7 Integrated set of recommendations, draft EU Guidelines and (educational) tools to facilitate DCT implementation in Europe |
M60 | Not started |
| D6.8 Final Data management plan |
M60 | Not started |
| D6.9 Ethics D1a, GEN-Requirement: Independent Ethics Advisor appointed to participate in the independent external expert panel |
M2 | Completed |
| D6.10 Ethics D1b, GEN-Requirement: report, including ethics section on the review of the proposed technology package for the WP3 pan-EU pilot study |
M18 | Completed (confidential) |
| D6.11 Ethics D4, POPD – Requirement No. 4: Updated data management plan |
M22 | Not started |
| D6.12 Ethics D1c, GEN-Requirement: report, including ethics section on the review of the updated version of the Data Management Plan –specific pan-EU pilot Data |
M23 | Not started |
| D6.13 Ethics D1d, GEN-Requirement: report, including ethics section on the review of the feasibility study and protocol for the pan-EU pilot study |
M23 | Not started |