Investigating started sample size, completed sample size and drop‐out rate in 10 252 phase III clinical trials: Insights from ClinicalTrials.gov

Our findings indicate that a majority of the analysed trials lack sufficient statistical power (80%) to detect small effect sizes, and approximately half of the trials did not have 80% power to detect medium effect sizes. Notably, trials funded by NIH/US Fed exhibit significantly smaller sample sizes compared to trials sponsored by industry. When conducting sample size calculations for clinical trials, it is crucial to consider the anticipated effect size, variability and drop-out rate.

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Publication Details

Journal
British Journal of Clinical Pharmacology
Published
2025-02-20
DOI
https://doi.org/10.1002/bcp.70023
Citations
1
Primary Topic
Statistical Methods in Clinical Trials
Type
article
Field-Weighted Citation Impact
2.63
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article

Investigating started sample size, completed sample size and drop‐out rate in 10 252 phase III clinical trials: Insights from ClinicalTrials.gov

Biwei Cao, Jinyong Pang, Henian Chen, Matthew J. Valente et al.
1 citations
British Journal of Clinical Pharmacology
Statistical Methods in Clinical Trials
2.63
article

Investigating started sample size, completed sample size and drop‐out rate in 10 252 phase III clinical trials: Insights from ClinicalTrials.gov

Biwei Cao, Jinyong Pang, Henian Chen, Matthew J. Valente, Elena Valkanova, Weiliang Cen, Yayi Zhao
article en
1 citations

Abstract

Our findings indicate that a majority of the analysed trials lack sufficient statistical power (80%) to detect small effect sizes, and approximately half of the trials did not have 80% power to detect medium effect sizes. Notably, trials funded by NIH/US Fed exhibit significantly smaller sample sizes compared to trials sponsored by industry. When conducting sample size calculations for clinical trials, it is crucial to consider the anticipated effect size, variability and drop-out rate.

British Journal of Clinical PharmacologyVol. 91(7)
University of South Florida (US)
Partnerships for the goals
Openalex Percentile: Top 14%
Statistical Methods in Clinical Trials
2.63
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