Evidence map›Paper›PMID 39077556›Full record

ArticleFrontiers in toxicology2024

sendigR: an R package to leverage the value of CDISC SEND datasets for cross-study analysis.

K Snyder, C M Sabbir Ahmed, Md Yousuf Ali, S Butler, Michael DeNieu, W Houser, B Paisley, M Rosentreter, W Wang, B Larsen

Abstract read
In one paragraph

Article in Frontiers in toxicology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. Cross study analyses of SEND data: toxicity profile classification.Toxicological sciences : an official journal of the Society of Toxicology · 2024
    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.

K SnyderUS Food and Drug Administration, Silver Spring, MD, United States.
C M Sabbir AhmedUS Food and Drug Administration, Silver Spring, MD, United States.
Md Yousuf AliUS Food and Drug Administration, Silver Spring, MD, United States.
S ButlerUS Food and Drug Administration, Silver Spring, MD, United States.
Michael DeNieuLabcorp, Madison, WI, United States.
W HouserBristol Myers Squibb, New Brunswick, NJ, United States.
B PaisleyEli Lilly & Co, Indianapolis, IN, United States.
M RosentreterBayer AG, Wuppertal, Germany.
W WangBristol Myers Squibb, New Brunswick, NJ, United States.
B LarsenNovo Nordisk, Copenhagen, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The CDISC Standard for Exchange of Nonclinical Data (SEND) data standard has created new opportunities for collaborative development of open-source software solutions to facilitate cross-study analyses of toxicology study data. A public-private partnership between BioCelerate and the FDA/Center for Drug Evaluation and Research (CDER) was established in part to develop and publicize novel methods to facilitate cross-study analysis of SEND datasets. As part of this work in collaboration with the Pharmaceutical Users Software Exchange (PHUSE), an R package sendigR has been developed to enable users to construct a relational database from a collection of SEND datasets and then query that database to perform cross-study analyses. The sendigR package also includes an integrated Python package, xptcleaner, which can be used to harmonize the terminology used in SEND datasets by mapping to CDISC controlled terminologies. The sendigR R package is freely available on the comprehensive R Archive Network (CRAN) and at https://github.com/phuse-org/sendigR. An R Shiny web application was included in the R package to enable toxicologists with no coding experience to perform historical control analyses. Experienced R programmers will be able to integrate the package functions into their own custom scripts/packages and potentially contribute improvements to the functionality of sendigR. sendigR reference manual: https://phuse-org.github.io/sendigR/. sendigR R Shiny demo app: https://phuse-org.shinyapps.io/sendigR/.

Indexed as

BioCelerateCDISC Standard for Exchange of Nonclinical Datacross-study analysissendigRtoxicology dataUnited States FDA

Identifiers

PMID39077556
PMCPMC11284615

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.