Evidence map›Paper›PMID 24038922›Full record

ArticlePharmaceutical statistics

A practical guide to Bayesian group sequential designs.

Thomas Gsponer, Florian Gerber, Björn Bornkamp, David Ohlssen, Marc Vandemeulebroecke, Heinz Schmidli

Registry-linked trialAbstract read
PubMed Publisher
In one paragraph

Article in Pharmaceutical statistics. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04466670 (Dynamics of Hemostatic Parameters in COVID-19 and Comparison of Intervention Strategies Through Adaptive Clinical Trial), which is not on this map. Cited by 30 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 2 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.

NCT04466670 phase2unknown statusnot on this map

Dynamics of Hemostatic Parameters in COVID-19 and Comparison of Intervention Strategies Through Adaptive Clinical Trial

TypeinterventionalSponsorUniversity of Sao Paulo General HospitalRan2020 to 2022Enrolled379ConditionsCOVID-19Armsacetylsalicylic acid, Unfractionated heparin nebulized
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Bayesian Approaches for Confirmatory Trials in Rare Diseases: Opportunities and Challenges.International journal of environmental research and public health · 2021
    Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Article
  8. Monitoring overall survival in pivotal trials in indolent cancers.Statistics in biopharmaceutical research · 2025
    Article
  9. Review
  10. Review
  11. Systemic therapies in hepatocellular carcinoma: A revolution?United European gastroenterology journal · 2024
    Review
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. The Bayesian Design of Adaptive Clinical Trials.International journal of environmental research and public health · 2021
    Review
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors.

Thomas GsponerInstitute of Social and Preventive Medicine, University of Bern, Bern, Switzerland.
Florian Gerber
Björn Bornkamp
David Ohlssen
Marc Vandemeulebroecke
Heinz Schmidli

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Bayesian approaches to the monitoring of group sequential designs have two main advantages compared with classical group sequential designs: first, they facilitate implementation of interim success and futility criteria that are tailored to the subsequent decision making, and second, they allow inclusion of prior information on the treatment difference and on the control group. A general class of Bayesian group sequential designs is presented, where multiple criteria based on the posterior distribution can be defined to reflect clinically meaningful decision criteria on whether to stop or continue the trial at the interim analyses. To evaluate the frequentist operating characteristics of these designs, both simulation methods and numerical integration methods are proposed, as implemented in the corresponding R package gsbDesign. Normal approximations are used to allow fast calculation of these characteristics for various endpoints. The practical implementation of the approach is illustrated with several clinical trial examples from different phases of drug development, with various endpoints, and informative priors.

Indexed as

Bayes TheoremResearch DesignClinical Trials as TopicCrohn DiseaseDrug DiscoveryHumansadaptive designBayesian inferencegroup sequential designgsbDesignoperating characteristicsprior

Identifiers

PMID24038922

What OpenQuestion holds

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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.