Activities & Operations

DCT approaches

Several approaches have been used in DCTs to move trial activities towards participants’ homes. A selection of these, which were used in RADIAL, are shown in the figure below. Others include postal or telephone contact, shipment of study materials to participants, use of local healthcare services and routine care, use of centralised healthcare databases to identify trial outcomes and wearable devices.  Different approaches will be appropriate for different trials and different participant populations and it is important to select the best approach carefully.

Recommendations

The choice of approach to be used in a trial should be informed by the needs of the participants, the clinical sites, and the research question under investigation. Requirements may differ in different participant populations and at different clinical sites. It may not be possible to use DCT approaches for all aspects of the trial.

This requires a thorough evaluation during the set-up of the trial on whether integration is possible, especially in settings where device or technology-specific data flows are already established.

Each decentralised element under consideration for inclusion in a trial should be individually assessed to ensure it is permitted in the participating countries, suitable and acceptable for the target study population and trial sites, and technically feasible given existing infrastructure and operational requirements (e.g., continuous broadband internet access).

How Trials@Home reached these recommendations

We conducted a systematic review to identify best practices within DCTs, in addition to interviews with stakeholders involved in DCT case studies. RADIAL also brought in-depth experience with multiple DCT approaches. This work identified some of the challenges and solutions regarding methods used in DCTs.

Further reading

Publications

Learning from Remote Decentralised Clinical Trial (RDCT) experiences: a qualitative analysis of interviews with trial personnel, patient representatives and other stakeholders.

Coyle, et al
British Journal of Clinical Pharmacology
2021
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View poster version

A Systematic Review of Methods used to Conduct Decentralised Clinical Trials.

Rogers, et al
British Journal of Clinical Pharmacology
2021
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View poster version

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

Coyle, et al
Trials
2022
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Bringing trial activities to participants – The Trials@Home RADIAL proof-of-concept trial on decentralisation.

Zuidgeest, et al
Clinical Pharmacology & Therapeutics
2025
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Regulatory Interactions and Learnings – RADIAL the Trials@Home Proof-of-Concept Trial on Decentralization.

Gardarsdottir, et al
Clinical Pharmacology & Therapeutics
2025
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Selecting and Preparing Clinical Sites for the Successful Conduct of Decentralized Clinical Trial Activities – Findings From the Trials@Home RADIAL Proof-of-Concept Trial.

Lipinska, et al
Clinical Pharmacology & Therapeutics
2025
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Recruiting and Consenting Decentralized Clinical Trial Participants – Learnings from the Trials@Home RADIAL Proof-of-Concept Trial.

Lagerwaard, et al
Clinical Pharmacology & Therapeutics
2025
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The Supply of Investigational Medicinal Product and Management of Study Materials for Decentralized Participants – Insights from the Trials@Home RADIAL Proof-of-Concept Trial.

Heath, et al
Clinical Pharmacology & Therapeutics
2025
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Operationalising Decentralised Clinical Trials: Technology Insights from the Trials@Home RADIAL Proof-of-Concept Trial.

Hanke, et al
Clinical Pharmacology & Therapeutics
2025
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A cross-sectional survey on the early impact of COVID-19 on the uptake of decentralised trial methods in the conduct of clinical trials.

Suman, et al
Trials
2022
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