Evidence map›Paper›PMID 40522722›Full record

ArticleJournal of medical Internet research2025

Adaptation of Clinical Research Staff to Decentralized Clinical Trials and Impacts on the Patient-Centered Experience: Qualitative Interview Study.

Eoin Gamble, Ciara Heavin, Conor Linehan

Abstract read
In one paragraph

Article in Journal of medical Internet research, 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.

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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

3 authors.

Eoin GambleSchool of Applied Psychology, University College Cork, Cork, Ireland.ORCID 0000-0002-2168-2448
Ciara HeavinO'Rahilly Building, College Rd, University College, Cork, Cork University Business School, University College Cork, Cork, Ireland.ORCID 0000-0001-8237-3350
Conor LinehanSchool of Applied Psychology, University College Cork, Cork, Ireland.ORCID 0000-0002-7654-6697

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIndustry stakeholders, academic experts, and regulatory bodies emphasize the importance of prioritizing a patient-centered experience in clinical trials to enhance retention, adherence, and trial participation. Concurrently, there has been a notable rise in the adoption of technology-mediated decentralized methodologies for conducting clinical trials. Nonetheless, is a truly patient-centric approach being achieved? The shift to decentralized approaches risks prioritizing operational efficiency and remote data collection over the nuanced and diverse needs of participants. This raises critical questions about whether the current implementation of decentralized clinical trials (DCTs) fully aligns with the principles of patient centeredness.

objectiveUsing a qualitative approach, our study aims to understand the perceptions of clinical research staff (CRS) of this transition and its impact on delivering a patient-centered experience.

methodsA total of 15 CRS with experience of facilitating DCTs were interviewed, and transcripts were analyzed.

resultsOur findings reveal 1 superordinate theme-the quality and frequency of interactions with patients and CRS are limited-and six main themes: (1) increasing demands of the CRS role, (2) creating difficulties for patients, (3) knowing the patient and understanding their experience, (4) impacts on forming and maintaining CRS-patient relationship, (5) difficulty in delivering desired level of support and care, and (6) perceived affects to conduct of a trial. While DCTs offer advantages in improving accessibility, they introduce new complexities that can negatively impact patient engagement, retention, and the CRS-patient relationship.

conclusionsThis study offers insights into the perspectives of CRS on delivering a patient-centered experience in DCTs. It highlights the benefits of DCTs alongside the challenges they present, emphasizing the need for additional support, training, streamlined technology, and resources to help CRS adapt to evolving trial dynamics. To fully realize the patient-centered potential of DCTs, technology and trial designers must recognize the complex interplay of factors shaping the patient experience. This requires collaboration with CRS and patients to address the diverse needs of all stakeholders, prioritizing the broader aspects of the patient experience beyond at-home convenience and data collection.

Indexed as

Clinical Trials as TopicPatient-Centered CareResearch PersonnelFemaleHumansInterviews as TopicMaleQualitative Researchclinical research technologyDCTdecentralized clinical trialdecentralized trialshuman centeredparticipant-centric trialspatient centerednesspatient experienceremote trialssite experience

Identifiers

PMID40522722
PMCPMC12209732

What OpenQuestion holds

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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.