9/2/2023 0 Comments Optimism bias studyAn effect size at least as large as the one projected in the protocol trials was observed in 9.8% of trials, compared with 17% of NCI trials published from 1955 to 2006. The median ratio of observed-to-expected hazard ratios among trials that observed a statistically significant effect on the primary end point was 1.07 (range: 0.33-1.28) versus 1.32 (range: 0.86-2.02) for trials that did not, compared with 1.34 and 1.86, respectively, for National Cancer Institute (NCI) trials published between 19. Twenty-eight trials (21.5%) observed a statistically significant difference in the primary end point favoring the experimental treatment. Original protocols could not be located for 8 trials (5.0%). ResultsWe identified 161 clinical trials, of which 130 were eligible for analysis. We also reviewed the methods of each protocol to assess whether a rationale for the hypothesized effect size was provided. We compared the hypothesized versus observed treatment effects in each trial, and examined whether trial-related factors were correlated with the study results. MethodsWe conducted a systematic review of NCTN phase III randomized trials published from January 2007 to January 2017. The prevalence of 'optimism bias' in contemporary National Clinical Trials Network (NCTN) cancer clinical trials is unknown. 'optimism bias') leads to underpowered clinical trials. BackgroundPrevious studies have found that overestimating treatment effects (i.e.
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