Project outputs

COVID‐19 and the Emerging Regulatory Guidance for Ongoing Clinical Trials in the European Union

Learning from remote decentralised clinical trial experiences: A qualitative analysis of interviews with trial personnel, patient representatives and other stakeholders

An Overview of Technology Availability to Support Remote Decentralized Clinical Trials

A Systematic Review of Methods used to Conduct Decentralised Clinical Trials

Opportunities and Challenges for Decentralized Clinical Trials: European Regulators’ Perspective

Ethics review of decentralized clinical trials (DCTs): Results of a mock ethics review.

A secondary qualitative analysis of stakeholder views about participant recruitment, retention, and adherence in decentralised clinical trials (DCTs)

Which decentralised trial activities are reported in clinical trial protocols of drug trials initiated in 2019-2020? A cross-sectional study in ClinicalTrials.gov

A cross-sectional survey on the early impact of COVID-19 on the uptake of decentralised trial methods in the conduct of clinical trials

Decentralised, patient-centric, site-less, virtual, and digital clinical trials? From confusion to consensus

Direct-to-Participant Investigational Medicinal Product Supply in Europe – Experiences from Sponsors, Site Study Staff, and Couriers

Opportunities and challenges for decentralized clinical trial approaches: European health technology assessment perspective

Which Benefits Can Justify Risks in Research?

Technology Support System and Review Process for a Decentralized Clinical Trial: Trials@Home, RADIAL DCT as Case Study

The Ethics of Decentralized Clinical Trials and Informed Consent: Taking Technologies’ Soft Impacts into Account.

The Digital Platform and its Emerging Role in Decentralized Clinical Trials

Regulatory readiness to facilitate the appropriate use of innovation in clinical trials: the case of decentralized clinical trial approaches

The Impact of Operational Trial Approaches on Representativeness: Comparison of Decentralized Clinical Trial Participants, Conventional Trial Participants, and Patients in Daily Practice

What motivates people living with type 2 diabetes mellitus to participate in clinical trials from home? Findings from a multi-country focus group study on decentralised clinical trial approaches.

Diversity in decentralized clinical trials: Prioritizing inclusion of underrepresented groups.

Diffused responsibilities in technology-driven health research: The case of artificial intelligence systems in decentralized clinical trials.

Bringing trial activities to participants – The Trials@Home RADIAL proof-of-concept trial on decentralisation

Regulatory Interactions and Learnings – RADIAL the Trials@Home Proof-of-Concept Trial on Decentralization

Selecting and Preparing Clinical Sites for the Successful Conduct of Decentralized Clinical Trial Activities – Findings From the Trials@Home RADIAL Proof-of-Concept Trial

Recruiting and Consenting Decentralized Clinical Trial Participants – Learnings from the Trials@Home RADIAL Proof-of-Concept Trial

Supply of Study Materials and Investigational Medicinal Product to Participants – Learnings and Challenges from the Trials@Home RADIAL Proof-Of-Concept Trial

Operationalising Decentralised Clinical Trials: Technology Insights from the Trials@Home RADIAL Proof-of-Concept Trial

Why and how do we perform physical examination(s) in clinical trials? A use case of drug intervention trials in type 2 diabetes mellitus

Bringing clinical trials home: European regulatory perspectives on decentralized clinical trial approaches (PhD thesis)

Which Benefits Can Justify Risks in Research? Response to Open Peer Commentaries

Do people prefer to take part in a clinical trial from home or come to site? A discrete choice experiment in type 2 diabetes mellitus

D1.1 – First set of recommendations for DCTs (to be implemented in the pan-EU pilot DCT)

D1.2 – Criteria for selection of appropriate trials

D1.3 – Update of recommendations based on ongoing case studies running in parallel to the WP3 pilot

D2.1 – Glossary of terms and definitions used within WP2

D2.2 – Detailed list of quality assessment criteria and assessment procedures

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

D2.7 – Technology support system

D2.8 – Updated summary and detailed report with recommendations for integrated technologies to be used in DCT and hybrid approaches, based on pilot findings

D3.2 – Finalised list of KPI’s to be used to qualify and quantify the flow of activities in the pilot

D3.5 – First study subject approvals package

D3.6 – Midterm recruitment report

D3.8 – Report on final evaluation of the Pan-EU pilot regarding KPI and learnings

D3.9 – Report on status of posting of final results

D4.1 – Map of the EU legislation on DCTs including legal, regulatory, ethical and stakeholder recommendations for conduct of the pan-EU pilot

D4.2 – SWOT analysis of ethical, legal and operational barriers and enablers for DCT in the EU

D4.3 – Overview of technical and regulatory implications of DCTs for efficient regulatory decision-making

D4.4 – Overview of innovative scenarios for a responsible and sustainable DCT ecosystem

D4.5 – Final EAGLE report

D5.2 – Trials@Home website, templates, and social media tools

D5.3 – Report on the mapping of paradigm changes in the relationships between HCPs and patients

D5.4 – Report on changing stakeholders’ roles and responsibilities and proposals from stakeholders to overcome any challenges

D5.5 – Education & Training Sessions

D5.6 – Set of tools for DCT including training materials for stakeholders

D6.3 – First version of DMP

D6.5 – Open call for additional technology partners

D6.6 – Final version of sustainability plan

D6.7 – Integrated set of recommendations, draft EU Guidelines and (educational) tools to facilitate RDCT implementation in Europe

D6.8 – Final version of Data management plan

D6.9 – Ethics D1a, GEN-Requirement: Independent Ethics Advisor appointed to participate in the independent external expert panel

D6.11 – Ethics D4, POPD – Requirement No. 4: Updated data management plan

What are digital literacy requirements for Decentralised Clinical Trials? A Delphi study to reach expert consensus

What is Trials@Home?

What is IMI?

(now IHI)

What are clinical trials?

What are DCTs?

Patient training on e-consent from RADIAL

The future of medical research

©The Lancet

Vital Health Podcast with Kim Hawkins project co-lead

RADIAL publicly available documents (protocol, patient facing materials etc.)

LinkedIn page

YouTube channel with webinars, conference videos etc.