Evidence map›Paper›PMID 41035203›Full record

ArticleClinical pharmacology and therapeutics2025

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

Katarzyna Lipinska, Danny van Weelij, Bart Lagerwaard, Linda Rutgrink, Eduard Vardianu, Petra Naster, Lina Pérez-Breva, Paul Bodfish, Megan Heath, Yvonne van Rijswick and 3 more

Abstract read
In one paragraph

Article in Clinical pharmacology and therapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Katarzyna LipinskaJulius Clinical Research, Zeist, The Netherlands.
Danny van WeelijJulius Clinical Research, Zeist, The Netherlands.ORCID https://orcid.org/0009-0002-3842-3861
Bart LagerwaardJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.ORCID https://orcid.org/0000-0001-8558-2385
Linda RutgrinkSanofi, Amsterdam, The Netherlands.ORCID https://orcid.org/0009-0002-2037-2461
Eduard VardianuFortrea, Bucharest, Romania.
Petra NasterVital Transformation, Wezembeek-Oppem, Belgium.
Lina Pérez-BrevaVaccine Research FISABIO-Public Health, Valencia, Spain.
Paul BodfishMedical Research Network Ltd, Milton Keynes, UK.
Megan HeathSanofi, Reading, UK.ORCID https://orcid.org/0009-0006-6272-3003
Yvonne van RijswickJulius Clinical Research, Zeist, The Netherlands.
Diederick E GrobbeeJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.ORCID https://orcid.org/0000-0003-4472-4468
Mira G P ZuidgeestJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.ORCID https://orcid.org/0000-0003-1463-8243
Trials@Home consortium

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Decentralized clinical trials (DCTs) offer opportunities to improve trial accessibility, participant convenience, and efficiency, yet may pose significant operational challenges for clinical trial sites. This paper presents the operational insights gained from selecting, training, and supporting clinical sites within the RADIAL proof-of-concept trial, part of the Trials@Home project. RADIAL was a multicenter, low-intervention phase IV trial comparing conventional, hybrid, and fully decentralized approaches for individuals with type 2 diabetes mellitus across six European countries. Site selection involved detailed feasibility assessments evaluating operational capabilities, recruitment potential, technological readiness, and willingness to implement decentralized elements. Despite proactive training, including ongoing support via a centralized helpdesk, sites faced initial difficulties with technology management and participant onboarding. Contractual complexities were prominent, particularly regarding clearly delineating responsibilities and data handling in agreements involving third-party providers. Moreover, integrating third-party services necessitated meticulous oversight strategies and continuous stakeholder coordination to ensure regulatory compliance and efficient trial management. Our experiences underscore essential considerations for future DCT implementations: proactive stakeholder alignment; tailored, timely, and ongoing training and support; intuitive technology design informed by clinical user input; robust, centralized oversight structures; and clearly defined delegation frameworks for third-party engagements. Addressing these operational considerations will facilitate smoother transitions toward decentralized clinical research models, maximizing their potential benefits while managing associated complexities effectively-especially for clinical site staff.

Indexed as

Clinical Trials as TopicDiabetes Mellitus, Type 2EuropeHumansMulticenter Studies as TopicProof of Concept Study

Identifiers

PMID41035203
PMCPMC12598118

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.