Evidence map›Paper›PMID 35131744›Full record

ArticleBMJ (Clinical research ed.)2022

Early phase clinical trials extension to guidelines for the content of statistical analysis plans.

Victoria Homer, Christina Yap, Simon Bond, Jane Holmes, Deborah Stocken, Katrina Walker, Emily J Robinson, Graham Wheeler, Sarah Brown, Samantha Hinsley and 9 more

Abstract read
In one paragraph

Article in BMJ (Clinical research ed.), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 3 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.

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

24 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
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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

19 authors.

Victoria HomerCancer Research Clinical Trials Unit, University of Birmingham, Birmingham, UK.
Christina YapClinical Trials and Statistics Unit, Institute for Cancer Research, London, UK.
Simon BondCambridge Clinical Trials Unit, Cambridge, UK.
Jane HolmesOxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Deborah StockenClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Katrina WalkerClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Emily J RobinsonRoyal Marsden Clinical Trials Unit, Royal Marsden NHS Foundation Trust, London, UK.
Graham WheelerImperial Clinical Trials Unit, Imperial College London, London, UK.
Sarah BrownClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
Samantha HinsleyCancer Research UK Glasgow Clinical Trials Unit, University of Glasgow, Glasgow, UK.
Matthew SchipperDepartments of Radiation Oncology and Biostatistics, University of Michigan, Ann Arbor, MI, USA.
Christopher J WeirEdinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.
Khadija RantellMedicines and Healthcare products Regulatory Agency, London, UK.
Thomas PriorEarly Development Oncology Statistics Department, Janssen Research and Development, Spring House, PA, USA.
Ly-Mee YuPrimary Care Clinical Trials Unit, University of Oxford, Oxford, UK.
John KirkpatrickRoche Products, Welwyn Garden City, UK.
Alun BeddingRoche Products, Welwyn Garden City, UK.
Carrol GambleLiverpool Clinical Trials Centre, University of Liverpool, Liverpool, UK.
Piers GauntCancer Research Clinical Trials Unit, University of Birmingham, Birmingham, UK p.gaunt@bham.ac.uk.ORCID 0000-0001-8665-300X

Funding

Cancer Research UK 25354Cancer Research UK 27294Cancer Research UK 28028
6 · The paper itself

Abstract

PubMed holds no abstract for this paper.

Indexed as

Clinical Trials as TopicData AnalysisGuidelines as Topic

Identifiers

PMID35131744
PMCPMC8819597

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.