Group sequential methods for interim monitoring of randomized clinical trials with time‐lagged outcome
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DOI: 10.1002/sim.9580
Abstract: The primary analysis in two‐arm clinical trials usually involves inference on a scalar treatment effect parameter; for example, depending on the outcome, the difference of treatment‐specific means, risk difference, risk ratio, or odds ratio. Most… read more here.
Keywords: time; clinical trials; interim analysis; trials time ... See more keywords
Remote digital monitoring in clinical trials in the time of COVID-19
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DOI: 10.1038/d41573-020-00094-0
Abstract: can be used in clinical trials to evaluate novel end points that provide information that was previously difficult or impossible to obtain. These technologies could also make trials more efficient and less burdensome to participants… read more here.
Keywords: monitoring clinical; clinical trials; remote digital; digital monitoring ... See more keywords
Aligning sample size calculations with estimands in clinical trials with time-to-event outcomes
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DOI: 10.4310/23-sii804
Abstract: The ICH E9(R1) guidance recommended a framework to align planning, design, conduct, analysis, and interpretation of any clincial trial with its objective and estimand. How to handle intercurrent events (ICEs) is one of the five… read more here.
Keywords: sample size; size; size calculation; time event ... See more keywords