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Frequent fragility of randomized controlled trials for HCC treatment.
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- Author(s): Zhang H;Zhang H; Li J; Li J; Zeng W; Zeng W
- Source:
BMC cancer [BMC Cancer] 2021 Apr 09; Vol. 21 (1), pp. 389. Date of Electronic Publication: 2021 Apr 09.- Publication Type:
Journal Article; Meta-Analysis; Systematic Review- Language:
English - Source:
- Additional Information
- Source: Publisher: BioMed Central Country of Publication: England NLM ID: 100967800 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2407 (Electronic) Linking ISSN: 14712407 NLM ISO Abbreviation: BMC Cancer Subsets: MEDLINE
- Publication Information: Original Publication: London : BioMed Central, [2001-
- Subject Terms:
- Abstract: Background: The fragility index (FI) of trial results can provide a measure of confidence in the positive effects reported in randomized controlled trials (RCTs). The aim of this study was to calculate the FI of RCTs supporting HCC treatments.
Methods: A methodological systematic review of RCTs in HCC treatments was conducted. Two-arm studies with randomized and positive results for a time-to-event outcome were eligible for the FI calculation.
Results: A total of 6 trails were included in this analysis. The median FI was 0.5 (IQR 0-10). FI was ≤7 in 4 (66.7%) of 6 trials; in those trials the fragility quotient was ≤1%.
Conclusion: Many phase 3 RCTs supporting HCC treatments have a low FI, which challenges the confidence in concluding the superiority of these drugs over control treatments. - References: Nature. 2019 Mar;567(7748):305-307. (PMID: 30894741)
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Clin Nutr. 2020 Apr;39(4):1284-1291. (PMID: 31221372) - Grant Information: No. 81603612 National Natural Science Foundation of China; NO.2018KJXX-093 Science and Technology Department of Shaanxi Province; NO.2019-YL05 Innovation Team of Shaanxi University of Traditional Chinese Medicine
- Contributed Indexing: Keywords: Endpoint; Fragility index; Randomized controlled trials
- Publication Date: Date Created: 20210410 Date Completed: 20210510 Latest Revision: 20210510
- Publication Date: 20240105
- Accession Number: PMC8034173
- Accession Number: 10.1186/s12885-021-08133-8
- Accession Number: 33836710
- Source:
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