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.
Glossary of terms and definitions used within WP2 (task 2.1.1)
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)
Technology package for the pan-EU pilot study including data flows and connections with external systems where necessary (task 2.3)
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)
Ongoing (Preliminary work being done as part of D6.3)
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)
Technology support system (task 2.6)
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)
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.
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
Finalised list of KPI’s to be used to qualify and quantify the flow of activities in the pilot
Draft protocol for pan-EU pilot to be used for small feasibility (dry-run) study ready and aligned across countries
Report on small feasibility study & proposed adaptations to the protocol to be made based on results & final protocol(s) for pan-EU pilot
First study subject approvals package
Midterm recruitment report
Audit report on process and ICH GCP deviations for the pan-EU pilot
Report on final evaluation of the Pan-EU pilot regarding KPI and learnings
Report on status of posting results
Ethics D2, H. Requirement No 2: pre-feasibility information package ready
Ethics D3, HCT – Requirement: human cells/tissues information package
Ethics D5, NEC – Requirement: non-EU activities
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.
Communication and Dissemination Plan
Trials@Home website, templates, and social media tools
Report on the mapping of paradigm changes in the relationships between HCPs and patients
Report on changing stakeholders’ roles and responsibilities and proposals from stakeholders to overcome any challenges
Education & Training Sessions
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