Evidence map›Paper›PMID 29133600›Full record

ArticleCirculation2018

Availability and Use of Shared Data From Cardiometabolic Clinical Trials.

Muthiah Vaduganathan, Amulya Nagarur, Arman Qamar, Ravi B Patel, Ann Marie Navar, Eric D Peterson, Deepak L Bhatt, Gregg C Fonarow, Clyde W Yancy, Javed Butler

Abstract read
In one paragraph

Article in Circulation, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Review
  2. Article
  3. 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

10 authors.

Muthiah VaduganathanBrigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA (M.V., A.Q., D.L.B.). mvaduganathan@bwh.harvard.edu.
Amulya NagarurDepartment of Medicine, Massachusetts General Hospital, Boston (A.N.).
Arman QamarBrigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA (M.V., A.Q., D.L.B.).
Ravi B PatelDivision of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL (R.B.P., C.W.Y.).
Ann Marie NavarDuke Clinical Research Institute and Division of Cardiology, Duke University Medical Center, Durham, NC (A.M.N., E.D.P.).
Eric D PetersonDuke Clinical Research Institute and Division of Cardiology, Duke University Medical Center, Durham, NC (A.M.N., E.D.P.).
Deepak L BhattBrigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA (M.V., A.Q., D.L.B.).
Gregg C FonarowAhmanson-UCLA Cardiomyopathy Center, University of California Los Angeles (G.C.F.).
Clyde W YancyDivision of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL (R.B.P., C.W.Y.).
Javed ButlerDivision of Cardiology, Stony Brook University, NY (J.B.).

Funding

TRAINING PROGRAM IN CARDIOVASCULAR RESEARCHT32HL007604 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI MARK W FEINBERG · 1985 to 2026
$19.0M
NHLBI NIH HHS T32 HL007604
6 · The paper itself

Abstract

backgroundSharing of patient-level clinical trial data has been widely endorsed. Little is known about how extensively these data have been used for cardiometabolic diseases. We sought to evaluate the availability and use of shared data from cardiometabolic clinical trials.

methodsWe extracted data from ClinicalStudyDataRequest.com, a large, multisponsor data-sharing platform hosting individual patient-level data from completed studies sponsored by 13 pharmaceutical companies.

resultsFrom January 2013 to May 2017, the platform had data from 3374 clinical trials, of which 537 (16%) evaluated cardiometabolic therapeutics (phase 1, 36%; phase 2, 17%; phase 2/3, 1%; phase 3, 42%; phase 4, 4%). They covered 74 therapies and 398 925 patients. Diabetes mellitus (60%) and hypertension (15%) were the most common study topics. Median time from study completion to data availability was 79 months. As of May 2017, ClinicalStudyDataRequest.com had received 318 submitted proposals, of which 163 had signed data-sharing agreements. Thirty of these proposals were related to cardiometabolic therapies and requested data from 79 unique studies (15% of all trials, 29% of phase 3/4 trials). Most (96%) data requesters of cardiometabolic clinical trial data were from academic centers in North America and Western Europe, and half the proposals were unfunded. Most proposals were for secondary hypothesis-generating questions, with only 1 proposed reanalysis of the original study primary hypothesis. To date, 3 peer-reviewed articles have been published after a median of 19 months (9-32 months) from the data-sharing agreement.

conclusionsDespite availability of data from >500 cardiometabolic trials in a multisponsor data-sharing platform, only 15% of these trials and 29% of phase 3/4 trials have been accessed by investigators thus far, and a negligible minority of analyses have reached publication.

Indexed as

Access to InformationCardiovascular DiseasesClinical Trials as TopicEuropeHeartHumansInformation DisseminationMyocardiumNorth AmericaOutcome and Process Assessment, Health CareResearch Support as Topicclinical trialinformation disseminationoutcome and process assessment (health care)research design

Identifiers

PMID29133600
PMCPMC5828960

What OpenQuestion holds

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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.