منابع مشابه
Futility stopping in clinical trials
Early stopping due to futility, also referred to as a go/nogo decision, during interim analysis has become an important feature of clinical trial designs. Current methods for futility stopping in literature are mostly based on conditional power or predictive power in conjunction with the theory of stochastic curtailment or group sequential design. They have certain drawbacks that have been note...
متن کاملComparison of four sequential methods allowing for early stopping of comparative clinical trials.
Phase III trials aim to assess whether a new treatment has superior efficacy than a standard treatment. Sequential methods, such as the sequential probability ratio test (SPRT), the triangular test (TT) and so-called one-parameter boundaries (OPB), now allow early stopping of such trials, both in the case of efficacy (alternative hypothesis; H(1)) and in the case of lack of efficacy (null hypot...
متن کاملConditionally unbiased estimation in phase II/III clinical trials with early stopping for futility
Seamless phase II/III clinical trials combine traditional phases II and III into a single trial that is conducted in two stages, with stage 1 used to answer phase II objectives such as treatment selection and stage 2 used for the confirmatory analysis, which is a phase III objective. Although seamless phase II/III clinical trials are efficient because the confirmatory analysis includes phase II...
متن کاملStatistical considerations for stopping systemic lupus erythematosus clinical trials earlier
Group sequential designs are used to potentially shorten randomized clinical trials and thereby reduce subject burden, improve safety, and save time and resources. Clinical trials comparing treatments for systemic lupus erythematosus (SLE) might adopt such designs if the ordinal outcome scales for SLE, such as the Systemic Lupus Activity Measure and Systemic Lupus Erythematosus Disease Activity...
متن کاملEvaluation of Clinical Trials
In a number of important clinical issues such as evaluation of the efficacy or effectiveness of therapeutic or preventive interventions as well as for comparing the harms of interventions, randomized controlled trials (RCTs) provide the highest levels of evidence, either directly or indirectly. It is obvious that critical appraisal of these studies to assess their validity and precision is of p...
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ژورنال
عنوان ژورنال: BMJ
سال: 2004
ISSN: 0959-8138,1468-5833
DOI: 10.1136/bmj.329.7465.525