![]() An 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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