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 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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Posted 21 Aug, 2020
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Frequent fragility of randomized controlled trials for HCC treatment
Posted 21 Aug, 2020
Received 18 Sep, 2020
Invitations sent on 31 Aug, 2020
On 31 Aug, 2020
On 16 Aug, 2020
On 15 Aug, 2020
On 15 Aug, 2020
On 12 Aug, 2020
On 20 Jun, 2020
Received 18 Jun, 2020
Invitations sent on 17 Jun, 2020
On 17 Jun, 2020
On 10 Jun, 2020
On 09 Jun, 2020
On 09 Jun, 2020
On 13 Apr, 2020
Received 11 Apr, 2020
On 27 Mar, 2020
Received 12 Mar, 2020
On 02 Mar, 2020
On 09 Jan, 2020
Invitations sent on 09 Jan, 2020
On 07 Jan, 2020
On 06 Jan, 2020
On 30 Dec, 2019
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