Evidence map›Paper›PMID 40735123›Full record

ArticleJournal of clinical and translational science2025

Insights from the trial innovation network's initial consultation process.

Paul A Harris, Nan Kennedy, Consuelo H Wilkins, Karen Lane, Gordon R Bernard, Jonathan D Casey, Daniel E Ford, Salina P Waddy, Ken L Wiley, Terri L Edwards and 35 more

Abstract read
In one paragraph

Article in Journal of clinical and translational science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

45 authors.

Paul A HarrisVanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.ORCID https://orcid.org/0000-0002-1744-2011
Nan KennedyVanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.ORCID https://orcid.org/0000-0003-1935-2973
Consuelo H WilkinsVanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.
Karen LaneJohns Hopkins University School of Medicine, Baltimore, MD, USA.ORCID https://orcid.org/0000-0002-7529-0714
Gordon R BernardVanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.
Jonathan D CaseyVanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.
Daniel E FordJohns Hopkins University School of Medicine, Baltimore, MD, USA.ORCID https://orcid.org/0000-0002-2549-2289
Salina P WaddyNational Center for Advancing Translational Sciences, Bethesda, MD, USA.
Ken L WileyNational Center for Advancing Translational Sciences, Bethesda, MD, USA.
Terri L EdwardsVanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.
Nichol McBeeJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Dixie D ThompsonUniversity of Utah Health, Salt Lake City, UT, USA.
Mary StroudVanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.
Emily S SerdozVanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.ORCID https://orcid.org/0000-0003-2512-7019
Sarah J NelsonVanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.
Michelle JonesVanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.ORCID https://orcid.org/0009-0008-1548-6740
Lindsay M EyzaguirreJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Leslie R BooneVanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.
Jessica BairdJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Colleen E LawrenceVanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.ORCID https://orcid.org/0009-0009-2543-3391
Elizabeth HolthouseJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Sarah K CookVanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.ORCID https://orcid.org/0000-0002-4906-7084
Maeve TischbeinVanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.ORCID https://orcid.org/0000-0003-1192-0673
Natalya AmrineVanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.
Tiffany ChenVanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.
Jodie CohenVanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.
LaShondra DeyampertVanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.
Natalie A DiltsVanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.ORCID https://orcid.org/0000-0001-7127-0444
Delicia BurtsVanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.
Amna BaigVanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.
Joseph G ChristodoulouVanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.
Mariela RodriguezVanderbilt Institute for Clinical and Translational Research, Nashville, TN, USA.
Edgar R MillerJohns Hopkins University School of Medicine, Baltimore, MD, USA.
James F CasellaJohns Hopkins University School of Medicine, Baltimore, MD, USA.
W Andrew MouldJohns Hopkins University School of Medicine, Baltimore, MD, USA.
J Michael DeanUniversity of Utah Health, Salt Lake City, UT, USA.
Daniel K BenjaminDuke University School of Medicine, Durham, North Carolina, 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
Marisha E PalmInstitute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA.ORCID https://orcid.org/0000-0002-9760-7196
Lori PooleDuke Clinical Research Institute, Durham, NC, USA.
Jeri S BurrUniversity of Utah Health, Salt Lake City, UT, USA.
Sara HassaniNational Center for Advancing Translational Sciences, Bethesda, MD, USA.
Angeline NanniJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Meghan HildrethJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Daniel F HanleyJohns Hopkins University School of Medicine, Baltimore, MD, USA.ORCID https://orcid.org/0000-0002-9536-4258

Funding

Johns Hopkins Institute for Clinical and Translational ResearchUM1TR004926 · NCATS · JOHNS HOPKINS UNIVERSITY · PI STEPHEN N. DAVIS, Daniel Ernest Ford · 2024 to 2026
$28.5M
Catalyzing and Harmonizing Operational Innovation for Recruitment (CHOIR)U24TR004432 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Paul A. Harris, CONSUELO HOPKINS WILKINS · 2023 to 2026
$20.9M
Engaging Cooperative Sites for Trial Acceleration, Trust, Innovation, and Capability (ECSTATIC)U24TR004437 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Gordon Raphael Bernard, Jonathan Dale Casey · 2023 to 2026
$19.9M
NCATS NIH HHS U24 TR004432NCATS NIH HHS U24 TR004437NCATS NIH HHS UM1 TR004926
6 · The paper itself

Abstract

Multicenter clinical trials are essential for evaluating interventions but often face significant challenges in study design, site coordination, participant recruitment, and regulatory compliance. To address these issues, the National Institutes of Health's National Center for Advancing Translational Sciences established the Trial Innovation Network (TIN). The TIN offers a scientific consultation process, providing access to clinical trial and disease experts who provide input and recommendations throughout the trial's duration, at no cost to investigators. This approach aims to improve trial design, accelerate implementation, foster interdisciplinary teamwork, and spur innovations that enhance multicenter trial quality and efficiency. The TIN leverages resources of the Clinical and Translational Science Awards (CTSA) program, complementing local capabilities at the investigator's institution. The Initial Consultation process focuses on the study's scientific premise, design, site development, recruitment and retention strategies, funding feasibility, and other support areas. As of 6/1/2024, the TIN has provided 431 Initial Consultations to increase efficiency and accelerate trial implementation by delivering customized support and tailored recommendations. Across a range of clinical trials, the TIN has developed standardized, streamlined, and adaptable processes. We describe these processes, provide operational metrics, and include a set of lessons learned for consideration by other trial support and innovation networks.

Indexed as

Multicenter studiesRecruitment Innovation Centerscientific consultationTrial Innovation CenterTrial Innovation Network

Identifiers

PMID40735123
PMCPMC12305380

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.