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- Scopus: eid_2-s2.0-85180468178
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Article: The impact of lowering the study design significance threshold to 0.005 on sample size in randomized cancer clinical trials
| Title | The impact of lowering the study design significance threshold to 0.005 on sample size in randomized cancer clinical trials |
|---|---|
| Authors | |
| Keywords | clinical trial P-value sample size threshold trial design |
| Issue Date | 18-Dec-2024 |
| Publisher | Cambridge University Press |
| Citation | Journal of Clinical and Translational Science, 2024, v. 8, n. 1 How to Cite? |
| 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. |
| Persistent Identifier | http://hdl.handle.net/10722/364183 |
| DC Field | Value | Language |
|---|---|---|
| dc.contributor.author | Leung, Tiffany H. | - |
| dc.contributor.author | Ho, James C. | - |
| dc.contributor.author | Wang, Xiaofei | - |
| dc.contributor.author | Lam, Wendy W. | - |
| dc.contributor.author | Pang, Herbert H. | - |
| dc.date.accessioned | 2025-10-25T00:35:20Z | - |
| dc.date.available | 2025-10-25T00:35:20Z | - |
| dc.date.issued | 2024-12-18 | - |
| dc.identifier.citation | Journal of Clinical and Translational Science, 2024, v. 8, n. 1 | - |
| dc.identifier.uri | http://hdl.handle.net/10722/364183 | - |
| dc.description.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. | - |
| dc.language | eng | - |
| dc.publisher | Cambridge University Press | - |
| dc.relation.ispartof | Journal of Clinical and Translational Science | - |
| dc.rights | This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License. | - |
| dc.subject | clinical trial | - |
| dc.subject | P-value | - |
| dc.subject | sample size | - |
| dc.subject | threshold | - |
| dc.subject | trial design | - |
| dc.title | The impact of lowering the study design significance threshold to 0.005 on sample size in randomized cancer clinical trials | - |
| dc.type | Article | - |
| dc.description.nature | published_or_final_version | - |
| dc.identifier.doi | 10.1017/cts.2023.699 | - |
| dc.identifier.scopus | eid_2-s2.0-85180468178 | - |
| dc.identifier.volume | 8 | - |
| dc.identifier.issue | 1 | - |
| dc.identifier.eissn | 2059-8661 | - |
| dc.identifier.issnl | 2059-8661 | - |