書誌事項
- タイトル別名
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- Conducting a pre-confirmatory clinical trial in case of insufficient participant accrual for an investigator-initiated confirmatory clinical trial
抄録
<p>Conducting confirmatory clinical trials initiated and managed by nonpharmaceutical company researchers is often unfeasible because the calculated sample size is excessively large. We propose an alternative approach: conducting a pre-confirmatory clinical trial with a relatively high type I error rate and limited sample size. Our approach involves the use of a significance level calculated based on the conditional probability (P2), which is the probability of having a true treatment effect, given that the statistical test shows statistical significance, and its application to sample size calculation for pre-confirmatory clinical trials.</p><p>We examined the performance and operational characteristics of our approach using a case study. For a confirmatory clinical trial that required 100 participants in each group, when our method was applied, a pre-confirmatory clinical trial required a considerably small number of participants. For example, for a P2 of 80 %, with no prior information on the treatment effect, and a power of 80 %, the significance level of our approach was calculated as 20 %. Based on these values, the sample size in each group was 52. Although insufficient participant accrual during confirmatory clinical trials may affect the conclusion of the trials, our approach can ameliorate the situation.</p>
収録刊行物
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- 計量生物学
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計量生物学 44 (1), 1-14, 2023-10-31
日本計量生物学会
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キーワード
詳細情報 詳細情報について
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- CRID
- 1390016892186291968
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- DOI
- 10.5691/jjb.44.1
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- ISSN
- 21856494
- 09184430
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- 本文言語コード
- ja
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- データソース種別
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- JaLC
- Crossref
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- 抄録ライセンスフラグ
- 使用不可