Frequent fragility of randomized controlled trials for HCC treatment

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 H...

Descripción completa

Detalles Bibliográficos
Autores principales: Zhang, Hao, Li, Jingtao, Zeng, Wenting
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8034173/
https://www.ncbi.nlm.nih.gov/pubmed/33836710
http://dx.doi.org/10.1186/s12885-021-08133-8
_version_ 1783676497258610688
author Zhang, Hao
Li, Jingtao
Zeng, Wenting
author_facet Zhang, Hao
Li, Jingtao
Zeng, Wenting
author_sort Zhang, Hao
collection PubMed
description 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12885-021-08133-8.
format Online
Article
Text
id pubmed-8034173
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-80341732021-04-12 Frequent fragility of randomized controlled trials for HCC treatment Zhang, Hao Li, Jingtao Zeng, Wenting BMC Cancer Research Article 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12885-021-08133-8. BioMed Central 2021-04-09 /pmc/articles/PMC8034173/ /pubmed/33836710 http://dx.doi.org/10.1186/s12885-021-08133-8 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research Article
Zhang, Hao
Li, Jingtao
Zeng, Wenting
Frequent fragility of randomized controlled trials for HCC treatment
title Frequent fragility of randomized controlled trials for HCC treatment
title_full Frequent fragility of randomized controlled trials for HCC treatment
title_fullStr Frequent fragility of randomized controlled trials for HCC treatment
title_full_unstemmed Frequent fragility of randomized controlled trials for HCC treatment
title_short Frequent fragility of randomized controlled trials for HCC treatment
title_sort frequent fragility of randomized controlled trials for hcc treatment
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8034173/
https://www.ncbi.nlm.nih.gov/pubmed/33836710
http://dx.doi.org/10.1186/s12885-021-08133-8
work_keys_str_mv AT zhanghao frequentfragilityofrandomizedcontrolledtrialsforhcctreatment
AT lijingtao frequentfragilityofrandomizedcontrolledtrialsforhcctreatment
AT zengwenting frequentfragilityofrandomizedcontrolledtrialsforhcctreatment

Ejemplares similares