Evidence map›Paper›PMID 37654775›Full record

ArticleJournal of clinical and translational science2023

Decentralized clinical trials in the trial innovation network: Value, strategies, and lessons learned.

Daniel F Hanley, Gordon R Bernard, Consuelo H Wilkins, Harry P Selker, Jamie P Dwyer, J Michael Dean, Daniel Kelly Benjamin, Sarah E Dunsmore, Salina P Waddy, Kenneth L Wiley and 14 more

Registry-linked trialOpen access · goldAbstract 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. It is linked to trial NCT06976515 (Initial Cohort Study for Remote Investigation of Eye Dryness), which is not on this map. Cited by 37 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 1 pooled it
13.2field-weighted citation impact, top 1% of its field
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.

NCT06976515 recruitingnot on this mapstarted 2025, after this paper: background citation

Initial Cohort Study for Remote Investigation of Eye Dryness: A Pilot and Feasibility Study

TypeobservationalSponsorUniversity of California, San FranciscoRan2025 to 2027Enrolled90ConditionsEvaporative Loss Dry Eye Disease
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 1 synthesis or guideline pooled it, 48 citations in OpenAlex.

  1. Guideline
  2. Article
  3. Article
  4. Article
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  7. Article
  8. Review
  9. Review
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  12. Decentralised clinical trials in India: Stakeholders' perspectives.The Indian journal of medical research · 2026
    Review
  13. Article
  14. Article
  15. Article
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  20. Review
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

24 authors at 8 institutions in 1 country.

Daniel F HanleyJohns Hopkins University School of Medicine, Baltimore, MD, USA.ORCID https://orcid.org/0000-0002-9536-4258
Gordon R BernardDepartment of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.
Consuelo H WilkinsDepartment of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.
Harry P SelkerDepartment of Medicine, Tufts University, Boston, MA, USA.ORCID https://orcid.org/0000-0001-5322-7178
Jamie P DwyerUniversity of Utah Health, Salt Lake City, UT, USA.
J Michael DeanUniversity of Utah Health, Salt Lake City, UT, USA.
Daniel Kelly BenjaminDuke University School of Medicine, Durham, NC, USA.
Sarah E DunsmoreNational Center for Advancing Translational Sciences, Bethesda, MD, USA.
Salina P WaddyNational Center for Advancing Translational Sciences, Bethesda, MD, USA.
Kenneth L WileyNational Center for Advancing Translational Sciences, Bethesda, MD, USA.
Marisha E PalmDepartment of Medicine, Tufts University, Boston, MA, USA.ORCID https://orcid.org/0000-0002-9760-7196
W Andrew MouldJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Daniel F FordJohns Hopkins Institute for Clinical and Translational Research, Baltimore, MD, USA.ORCID https://orcid.org/0000-0002-2549-2289
Jeri S BurrUniversity of Utah Health, Salt Lake City, UT, USA.
Jacqueline HuvaneDuke Clinical Research Institute, Durham, NC, USA.
Karen LaneJohns Hopkins University School of Medicine, Baltimore, MD, USA.ORCID https://orcid.org/0000-0002-7529-0714
Lori PooleDuke Clinical Research Institute, Durham, NC, USA.
Terri L EdwardsVanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.
Nan KennedyVanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.ORCID https://orcid.org/0000-0003-1935-2973
Leslie R BooneVanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.
Jasmine BellVanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.ORCID https://orcid.org/0000-0002-9212-6932
Emily SerdozVanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.ORCID https://orcid.org/0000-0003-2512-7019
Loretta M ByrneVanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.ORCID https://orcid.org/0000-0003-0009-1144
Paul A HarrisVanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.ORCID https://orcid.org/0000-0002-1744-2011
Johns Hopkins University · USNational Center for Advancing Translational Sciences · USUniversity of Utah · USClinical Research Institute · USTufts University · USVanderbilt University Medical Center · USDuke University · USMeharry Medical College · US

Funding

Utah Trial Innovation CenterU24TR001597 · NCATS · UNIVERSITY OF UTAH · PI DEAN, JONATHAN MICHAEL · 2016 to 2022
$39.6M
Johns Hopkins-Tufts Trial Innovation Center HEAL Pain ERN SupplementU24TR001609 · NCATS · JOHNS HOPKINS UNIVERSITY · PI HANLEY, DANIEL F · 2016 to 2022
$36.3M
NCATS NIH HHS U24 TR001597NCATS NIH HHS U24 TR001609
6 · The paper itself

Abstract

New technologies and disruptions related to Coronavirus disease-2019 have led to expansion of decentralized approaches to clinical trials. Remote tools and methods hold promise for increasing trial efficiency and reducing burdens and barriers by facilitating participation outside of traditional clinical settings and taking studies directly to participants. The Trial Innovation Network, established in 2016 by the National Center for Advancing Clinical and Translational Science to address critical roadblocks in clinical research and accelerate the translational research process, has consulted on over 400 research study proposals to date. Its recommendations for decentralized approaches have included eConsent, participant-informed study design, remote intervention, study task reminders, social media recruitment, and return of results for participants. Some clinical trial elements have worked well when decentralized, while others, including remote recruitment and patient monitoring, need further refinement and assessment to determine their value. Partially decentralized, or "hybrid" trials, offer a first step to optimizing remote methods. Decentralized processes demonstrate potential to improve urban-rural diversity, but their impact on inclusion of racially and ethnically marginalized populations requires further study. To optimize inclusive participation in decentralized clinical trials, efforts must be made to build trust among marginalized communities, and to ensure access to remote technology.

Indexed as

CTSADecentralized trialshybrid trialsinclusive recruitmentMyCapremote data collectionremote interventionremote recruitmentremote technologyremote trial monitoringremote trialsrural recruitmenttrial innovation network

Identifiers

PMID37654775
PMCPMC10465321
OpenAlexW4385234335

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.