Evidence map›Paper›PMID 29083951›Full record

ReviewJournal of biopharmaceutical statistics2018

Design, data monitoring, and analysis of clinical trials with co-primary endpoints: A review.

Toshimitsu Hamasaki, Scott R Evans, Koko Asakura

Abstract readReview
In one paragraph

Review in Journal of biopharmaceutical statistics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing 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

19 citing papers in PubMed.

  1. Trial
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  3. Trial
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  5. Article
  6. Review
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  8. Article
  9. Article
  10. A Vector Theory of Assessing Clinical Trials: An Application to Bioequivalence.Journal of cardiovascular development and disease · 2024
    Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Review
  16. Article
  17. Article
  18. Article
  19. 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

3 authors.

Toshimitsu Hamasakia Department of Data Science , National Cerebral and Cardiovascular Center , Osaka , Japan.ORCID 0000-0002-4928-1160
Scott R Evansc Department of Biostatistics and the Center for Biostatistics in AIDS Research , Harvard T.H. Chan School of Public Heath , MA , USA.
Koko Asakuraa Department of Data Science , National Cerebral and Cardiovascular Center , Osaka , Japan.

Funding

Leadership and Operations Center (LOC), AIDS Clinical Trials Group (ACTG); LOC 1/UM1AI068636 · NIAID · UNIV OF NORTH CAROLINA CHAPEL HILL · PI Joseph J Eron, RAJESH T GANDHI · 2011 to 2026
$1073.1M
Statistical and Data Management Center (SDMC), AIDS Clinical Trials Group (ACTG)UM1AI068634 · NIAID · HARVARD UNIVERSITY D/B/A HARVARD SCHOOL OF PUBLIC HEALTH · PI Marlene Ann Cooper, Michael David Hughes · 2011 to 2026
$246.6M
Antibacterial Resistance Leadership Group (ARLG)UM1AI104681 · NIAID · DUKE UNIVERSITY · PI Vance G. Fowler, Henry F HENRY CHAMBERS · 2013 to 2026
$180.8M
Validation, CLIA and Qualification (VQC): Enhancing the RS ratio as a tool for AIDS Clinical Trial Group (ACTG) tuberculosis trialsUM1AI106701 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Grace M Aldrovandi · 2014 to 2026
$116.8M
Statistical and Data Management Center for the AIDS Clinical Trials GroupU01AI068634 · NIAID · HARVARD SCHOOL OF PUBLIC HEALTH · PI HUGHES, MICHAEL DAVID · 2006 to 2010
$71.9M
NIAID NIH HHS U01 AI068634NIAID NIH HHS UM1 AI068634NIAID NIH HHS UM1 AI104681
6 · The paper itself

Abstract

We review the design, data monitoring, and analyses of clinical trials with co-primary endpoints. Recently developed methods for fixed-sample and group-sequential settings are described. Practical considerations are discussed, and guidance for the application of these methods is provided.

Indexed as

Data Interpretation, StatisticalModels, StatisticalClinical Trials as TopicEndpoint DeterminationGuidelines as TopicHumansResearch DesignSample SizeCo-primary endpoints (CPE)fixed-sample designsgroup-sequential designsintersection–union test (IUT)multiple primary endpoints (MPE)type II error adjustment

Identifiers

PMID29083951
PMCPMC6135538

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.