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
  • 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.
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    • 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