Evidence map›Paper›PMID 27530374›Full record

ArticleCPT: pharmacometrics & systems pharmacology2016

Model-Based Assessment of Alternative Study Designs in Pediatric Trials. Part II: Bayesian Approaches.

G Smania, P Baiardi, A Ceci, M Cella, P Magni

Abstract read
In one paragraph

Article in CPT: pharmacometrics & systems pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Review
  5. 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

5 authors.

G SmaniaConsorzio per Valutazioni Biologiche e Farmacologiche, Via Luigi Porta 14, Pavia, Italy.
P BaiardiDirezione Scientifica Centrale, Fondazione Salvatore Maugeri, IRCCS, Via Salvatore Maugeri 4, Pavia, Italy.
A CeciConsorzio per Valutazioni Biologiche e Farmacologiche, Via Luigi Porta 14, Pavia, Italy.
M CellaConsorzio per Valutazioni Biologiche e Farmacologiche, Via Luigi Porta 14, Pavia, Italy.
P MagniDipartimento di Ingegneria Industriale e dell'Informazione, Università degli Studi di Pavia, Via Ferrata 5, Pavia, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This study presents a pharmacokinetic-pharmacodynamic based clinical trial simulation framework for evaluating the performance of a fixed-sample Bayesian design (BD) and two alternative Bayesian sequential designs (BSDs) (i.e., a non-hierarchical (NON-H) and a semi-hierarchical (SEMI-H) one). Prior information was elicited from adult trials and weighted based on the expected similarity of response to treatment between the pediatric and adult populations. Study designs were evaluated in terms of: type I and II errors, sample size per arm (SS), trial duration (TD), and estimate precision. No substantial differences were observed between NON-H and SEMI-H. BSDs require, on average, smaller SS and TD compared to the BD, which, on the other hand, guarantees higher estimate precision. When large differences between children and adults are expected, BSDs can return very large SS. Bayesian approaches appear to outperform their frequentist counterparts in the design of pediatric trials even when little weight is given to prior information from adults.

Indexed as

Bayes TheoremModels, StatisticalChildHumansMonte Carlo MethodRandomized Controlled Trials as TopicResearch DesignSample Size

Identifiers

PMID27530374
PMCPMC4999603

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.