Objectives and key deliverables

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The six Work Packages (WPs) of Trials@Home and their interdependencies.

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1. Best practices in DCT’S

WP1 BEST has three objectives:

  1. To collect and analyse prior and ongoing experiences with DCTs;
  2. To provide best practices, selection criteria and recommendations for implementation into the WP3 PILOT.
  3. 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

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2. Technologies – barries, enablers and data management

WP2 TECH has the following objectives:

  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 DCT, 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 DCT, based on chosen therapeutic areas and study protocol.
  5. To design, assemble and test the infrastructure for the selected technology package for the WP3 pan-EU pilot DCT.
  6. To provide technical support for the training in, and use of the resulting composition platform to those parties involved in the clinical trial.
  7. 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

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3. Pan-EU RDCT pilot

WP3 PILOT has the following objectives:

  1. To design, set-up and run a pan-EU pilot, comparing traditional clinical trial approaches to fully and hybrid DCT approaches.
  2. 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

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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:

  1. Map and analyse the ethical, regulatory, GCP and legal aspects (regulations and guidelines) of the current EU environment for DCT
  2. Identify challenges and solutions for the evolution of DCT within the clinical regulatory framework, including digital health.
  3. Analyse the acceptability of the DCT approach for benefit-risk decision making by regulators and HTA bodies.
  4. 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

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5. Communication, dissemination & stake-holder engagement

WP5 CODE aimes to:

  1. 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.
  2. 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.
  3. To measure and quantify the paradigm change from traditional trial approaches to induced changes in DCTs from the perspectives of patients and HCPs.
  4. To assess and tailor the related services of the ‘technology package’ resulting from WP2 TECH for the communication activities.
  5. 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.
  6. 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.
  7. 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

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6. PROject Management and Synthesis

WP6 PROMS will:

  1. 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
  2. Set-up an effective internal communication infrastructure and foster the integrative process within the consortium
  3. 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)
  4. Plan for, organise and coordinate an open call for additional technology partners
  5. Develop a sustainability plan for optimal translation and implementation of project results within and beyond the project duration
  6. 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