Trials stopped early for benefit? Not so fast!
نویسندگان
چکیده
Data extraction: Twelve reviewers working independently and in duplicate abstracted data on content area and type of intervention tested, reporting of funding, type of end point driving study termination, treatment effect, length of followup, estimated sample size and total sample studied, role of a data and safety monitoring board in stopping the study, number of interim analyses planned and conducted, and existence and type of monitoring methods, statistical boundaries, and adjustment procedures for interim analyses and early stopping.
منابع مشابه
Randomized trials addressing a similar question are commonly published after a trial stopped early for benefit.
OBJECTIVE We explored how investigators of ongoing or planned trials respond to the publication of a trial stopped early for benefit addressing a similar question. STUDY DESIGN AND SETTING We searched multiple databases from the date of publication of the truncated trial through August, 2015. Independent reviewers selected trials and extracted data. RESULTS We identified 207 trials truncate...
متن کاملRandomized trials stopped early for benefit: a systematic review.
CONTEXT Randomized clinical trials (RCTs) that stop earlier than planned because of apparent benefit often receive great attention and affect clinical practice. Their prevalence, the magnitude and plausibility of their treatment effects, and the extent to which they report information about how investigators decided to stop early are, however, unknown. OBJECTIVE To evaluate the epidemiology a...
متن کاملBiases in clinical trials with sequential monitoring
Objectives It is well known that a sequentially monitored clinical trial that stops early for benefit has a crude treatment difference that overestimates the true treatment effect. This has led to extended debate in the literature, with some researchers arguing that early stopping is an important source of bias in meta-analyses of clinical trials. We therefore investigated the implications of e...
متن کاملInitiation and continuation of randomized trials after the publication of a trial stopped early for benefit asking the same study question: STOPIT-3 study design
BACKGROUND Randomized control trials (RCTs) stopped early for benefit (truncated RCTs) are increasingly common and, on average, overestimate the relative magnitude of benefit by approximately 30%. Investigators stop trials early when they consider it is no longer ethical to enroll patients in a control group. The goal of this systematic review is to determine how investigators of ongoing or pla...
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عنوان ژورنال:
- Critical Care
دوره 11 شماره
صفحات -
تاریخ انتشار 2007