Evidence map›Paper›PMID 38028335›Full record

ArticleJournal of clinical and translational science2023

From a decentralized clinical trial to a decentralized and clinical-trial-in-a-box platform: Towards patient-centric and equitable trials.

Dorothy Dulko, Manlik Kwong, Marisha E Palm, Ludovic Trinquart, Harry P Selker

Abstract read
In one paragraph

Article in Journal of clinical and translational science, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

7 citing papers in PubMed.

  1. Article
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  6. Review
  7. Progress toward realizing the promise of decentralized clinical trials.Journal of clinical and translational science · 2024
    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

5 authors.

Dorothy DulkoInstitute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA.ORCID https://orcid.org/0000-0003-0274-1657
Manlik KwongInstitute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA.
Marisha E PalmInstitute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA.ORCID https://orcid.org/0000-0002-9760-7196
Ludovic TrinquartInstitute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA.
Harry P SelkerInstitute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA.ORCID https://orcid.org/0000-0001-5322-7178

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background/Objective: Despite the intuitive attractiveness of bringing research to participants rather than making them come to central study sites, widespread decentralized enrollment has not been common in clinical trials. Methods: The need for clinical research in the context of the COVID-19 pandemic, along with innovations in technology, led us to use a decentralized trial approach in our Phase 2 COVID-19 trial. We used real-time acquisition and transmission of health-related data using home-based monitoring devices and mobile applications to assess outcomes. This approach not only avoids spreading COVID-19 but it also can support inclusion of participants in more diverse socioeconomic circumstances and in rural settings. Results: Our team developed and deployed a decentralized trial platform to support patient engagement and adverse event reporting. Clinicians, engineers, and informaticians on our research team developed a Clinical-Trial-in-a-Box tool to optimally collect and analyze data from multiple decentralized platforms. Conclusion: Applying the decentralized model in Long COVID, using digital health technology and personal devices integrated with our telehealth platform, we share the lessons learned from our work, along with challenges and future possibilities.

Indexed as

clinical trialDecentralizedrecruitmentremote research data acquisitiontelehealth platform

Identifiers

PMID38028335
PMCPMC10663768

What OpenQuestion holds

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LicenceCC BY
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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.