Clinical trials are planned to stop when one of the following is reached
length of follow up goal
scheduled date of closure
Unplanned early stopping of trials may occur for a number of reasons (e.g. lack of funding, failure to recruit participants), which may affect the internal validity of the study
should be planned a priori
ideally involve an independent data monitoring committee
multiple statistical examinations of accumulating data without appropriate correction can lead to erroneous results and interpretations, this must be corrected for (e.g. if five interim analyses that use a P value of 0.05 are performed, the overall false positive rate is nearer to 19% than to the nominal 5%)
REASONS FOR EARLY STOPPING
interim analysis showing larger than expected benefit or harm from an intervention
futility (evidence of no important difference between experimental and control interventions)
trial becomes non-viable (e.g. funding vanishes, researchers cannot access eligible patients or study interventions, or other studies make the research question irrelevant)
Full reporting of why a trial ended is important for evidence based decision making
Trials that stop early for reasons apparently independent of trial findings, and trials that reach their planned termination, are unlikely to introduce bias by stopping
After finishing his medical degree at the University of Auckland, he continued post-graduate training in New Zealand as well as Australia’s Northern Territory, Perth and Melbourne. He has completed fellowship training in both intensive care medicine and emergency medicine, as well as post-graduate training in biochemistry, clinical toxicology, clinical epidemiology, and health professional education.
He is actively involved in in using translational simulation to improve patient care and the design of processes and systems at Alfred Health. He coordinates the Alfred ICU’s education and simulation programmes and runs the unit’s education website, INTENSIVE. He created the ‘Critically Ill Airway’ course and teaches on numerous courses around the world. He is one of the founders of the FOAM movement (Free Open-Access Medical education) and is co-creator of litfl.com, the RAGE podcast, the Resuscitology course, and the SMACC conference.
His one great achievement is being the father of two amazing children.
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