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Research article
Frequent fragility of randomized controlled trials for HCC treatment
Wenting Zeng
Guangzhou Medical College First Affiliated Hospital
Corresponding Author
ORCiD: https://orcid.org/0000-0003-2372-5066
License:
This work is licensed under a CC BY 4.0 License. Read Full License
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.
Keywords
Fragility index, Randomized controlled trials, Endpoint
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CURRENT STATUS: Under Review
Version 3
Posted 21 Aug, 2020
No community comments so far
Review #1 received
Received 18 Sep, 2020
Reviewers invited
Invitations sent on 31 Aug, 2020
Reviewer #1 agreed
On 31 Aug, 2020
Editor assigned
On 16 Aug, 2020
Submission checks complete
On 15 Aug, 2020
Editor invited
On 15 Aug, 2020
No comments provided
Editorial decision: Minor revision
On 12 Aug, 2020
Reviewer #2 agreed
On 20 Jun, 2020
Review #1 received
Received 18 Jun, 2020
Reviewers invited
Invitations sent on 17 Jun, 2020
Reviewer #1 agreed
On 17 Jun, 2020
Editor assigned
On 10 Jun, 2020
Submission checks complete
On 09 Jun, 2020
Editor invited
On 09 Jun, 2020
No comments provided
Editorial decision: Major revision
On 13 Apr, 2020
Review #2 received
Received 11 Apr, 2020
Reviewer #2 agreed
On 27 Mar, 2020
Review #1 received
Received 12 Mar, 2020
Reviewer #1 agreed
On 02 Mar, 2020
Editor assigned
On 09 Jan, 2020
Reviewers invited
Invitations sent on 09 Jan, 2020
Submission checks complete
On 07 Jan, 2020
Editor invited
On 06 Jan, 2020
First submitted
On 30 Dec, 2019
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This preprint is under consideration at BMC Cancer. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research article
Frequent fragility of randomized controlled trials for HCC treatment
Wenting Zeng
Guangzhou Medical College First Affiliated Hospital
Corresponding Author
ORCiD: https://orcid.org/0000-0003-2372-5066
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 3
Posted 21 Aug, 2020
No community comments so far
Review #1 received
Received 18 Sep, 2020
Reviewers invited
Invitations sent on 31 Aug, 2020
Reviewer #1 agreed
On 31 Aug, 2020
Editor assigned
On 16 Aug, 2020
Submission checks complete
On 15 Aug, 2020
Editor invited
On 15 Aug, 2020
No comments provided
Editorial decision: Minor revision
On 12 Aug, 2020
Reviewer #2 agreed
On 20 Jun, 2020
Review #1 received
Received 18 Jun, 2020
Reviewers invited
Invitations sent on 17 Jun, 2020
Reviewer #1 agreed
On 17 Jun, 2020
Editor assigned
On 10 Jun, 2020
Submission checks complete
On 09 Jun, 2020
Editor invited
On 09 Jun, 2020
No comments provided
Editorial decision: Major revision
On 13 Apr, 2020
Review #2 received
Received 11 Apr, 2020
Reviewer #2 agreed
On 27 Mar, 2020
Review #1 received
Received 12 Mar, 2020
Reviewer #1 agreed
On 02 Mar, 2020
Editor assigned
On 09 Jan, 2020
Reviewers invited
Invitations sent on 09 Jan, 2020
Submission checks complete
On 07 Jan, 2020
Editor invited
On 06 Jan, 2020
First submitted
On 30 Dec, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
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.
Figure 1
Figure 2
Figure 3