Evidence map›Paper›PMID 30480665›Full record

ArticleScientific data2018

Overview and experience of the YODA Project with clinical trial data sharing after 5 years.

Joseph S Ross, Joanne Waldstreicher, Stephen Bamford, Jesse A Berlin, Karla Childers, Nihar R Desai, Ginger Gamble, Cary P Gross, Richard Kuntz, Richard Lehman and 4 more

Abstract read
In one paragraph

Article in Scientific data, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 3 pooled it
–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

32 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
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  4. Article
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  7. Comment: Advancing Clinical Trials with Novel Designs and Implementations.Statistical science : a review journal of the Institute of Mathematical Statistics · 2023
    Article
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  20. Big Data in Nephrology.Nature reviews. Nephrology · 2021
    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

14 authors.

Joseph S RossSection of General Medicine, Department of Medicine, Yale School of Medicine, New Haven, CT, USA.ORCID 0000-0002-9218-3320
Joanne WaldstreicherJohnson & Johnson, New Brunswick, NJ, USA.
Stephen BamfordJanssen Pharmaceutical Companies of Johnson & Johnson, High Wycombe, UK.
Jesse A BerlinJohnson & Johnson, New Brunswick, NJ, USA.
Karla ChildersJohnson & Johnson, New Brunswick, NJ, USA.
Nihar R DesaiCenter for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA.
Ginger GambleCenter for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA.
Cary P GrossSection of General Medicine, Department of Medicine, Yale School of Medicine, New Haven, CT, USA.
Richard KuntzMedtronic, Inc., Minneapolis, MN, USA.
Richard LehmanStonebank Medical Ltd., Banbury, UK.
Peter LinsJohnson & Johnson, New Brunswick, NJ, USA.
Sandra A MorrisJohnson & Johnson, New Brunswick, NJ, USA.
Jessica D RitchieCenter for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA.
Harlan M KrumholzNational Clinician Scholars Program, Yale School of Medicine, New Haven, CT, USA.ORCID 0000-0003-2046-127X

Funding

Yale-Mayo FDA Center for Excellence in Regulatory Science and InnovationU01FD005938 · FDA · YALE UNIVERSITY · PI Joseph Solomon Ross · 2016 to 2026
$25.4M
Understanding hospital value: provider, hospital and community effectsR01HS022882 · AHRQ · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI HORWITZ, LEORA · 2014 to 2023
$2.9M
Medical reversals: De-implementing ineffective and unsafe treatmentsR01HS025164 · AHRQ · UNIVERSITY OF MINNESOTA · PI KARACA-MANDIC, PINAR · 2017 to 2020
$1.4M
Optimizing Medical Device Post-Market Surveillance for Public ValueU01FD004585 · FDA · YALE UNIVERSITY · PI KRUMHOLZ, HARLAN MARC · 2012 to 2016
$592k
AHRQ HHS R01 HS022882AHRQ HHS R01 HS025164FDA HHS U01 FD004585FDA HHS U01 FD005938
6 · The paper itself

Abstract

The Yale University Open Data Access (YODA) Project has facilitated access to clinical trial data since 2013. The purpose of this article is to provide an overview of the Project, describe key decisions that were made when establishing data sharing policies, and suggest how our experience and the experiences of our first two data generator partners, Medtronic, Inc. and Johnson & Johnson, can be used to enhance other ongoing or future initiatives.

Indexed as

Clinical Trials as TopicHumansInformation Dissemination

Identifiers

PMID30480665
PMCPMC6257043

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.