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Patients in whom life-sustaining therapies were withdrawn or withheld increased over time (5%% in the control period vs 18%% in the study period, p = 0.008), suggesting the increased use of ICU trials with time.
In trials with time to event outcomes, an analysis that includes all randomised participants with censoring at the point of loss to follow-up is generally acceptable, but possible biases from informative censoring should be considered.
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In this paper, a one-sample log-rank test is introduced for the design and analysis of phase II cancer clinical trials with time-to-event endpoints.
The proposed hybridization, along with a novel resampling method, can be used together to assess futility in sequential trials with time-to-event outcomes.
The semi-parametric proportional hazards model is widely adopted in randomized clinical trials with time-to-event outcomes, and the log-rank test is frequently used to detect a potential treatment effect.
31 However, this has not been investigated comprehensively for trials with time-to-event outcomes with crossovers.
Choodari-Oskooei et al. [ 15] investigated the extent of this bias for two-arm multi-stage trials with time-to-event outcomes.
Using simulations, we investigated the effect of crossovers on various analysis populations in non-inferiority trials with time-to-event outcomes.
Using simulations, we investigate the effect of 2%, 5% and 10% random and non-random crossovers prior to radiotherapy initiation on the ITT, PP, AT and the combination of ITT and PP analyses with respect to type I error in trials with time-to-event outcomes.
Ten studies (67%) were based on randomised clinical trials (RCTs) with time horizons ranging from 6 to 24 months.
Samuelson, 50, qualified for her sixth Olympic trials with a time of 2 46:2 46
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