Evidence map›Paper›PMID 38384917›Full record

ArticleJournal of clinical and translational science2024

The impact of lowering the study design significance threshold to 0.005 on sample size in randomized cancer clinical trials.

Tiffany H Leung, James C Ho, Xiaofei Wang, Wendy W Lam, Herbert H Pang

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of clinical and translational science, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Tiffany H LeungDepartment of Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.
James C HoDepartment of Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.
Xiaofei WangDepartment of Biostatistics and Bioinformatics, School of Medicine, Duke University, Durham, NC, USA.
Wendy W LamSchool of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.
Herbert H PangDepartment of Biostatistics and Bioinformatics, School of Medicine, Duke University, Durham, NC, USA.ORCID https://orcid.org/0000-0002-7896-6716

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The proposal of improving reproducibility by lowering the significance threshold to 0.005 has been discussed, but the impact on conducting clinical trials has yet to be examined from a study design perspective. The impact on sample size and study duration was investigated using design setups from 125 phase II studies published between 2015 and 2022. The impact was assessed using percent increase in sample size and additional years of accrual with the medians being 110.97% higher and 2.65 years longer respectively. The results indicated that this proposal causes additional financial burdens that reduce the efficiency of conducting clinical trials.

Indexed as

clinical trialP-valuesample sizethresholdtrial design

Identifiers

PMID38384917
PMCPMC10877511

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.