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Therefore, new clinical study paradigms, such as cluster randomization and therapeutic strategy trials, are needed.
As a sequel to last week's paper on the fundamentals of clinical trial design, this paper tackles related controversial issues: noninferiority trials, the value of factorial designs, the importance and challenges of strategy trials, Data Monitoring Committees (including when to stop a trial early), and the role of adaptive designs.
We also believe that modernising biologic treatment regimens for rheumatoid arthritis requires more strategy trials.
From the identified strategy trials, data were extracted concerning definitions of targets and success rates of applied strategies.
The four memory strategy trials reported that training was supervised by psychologists or neuropsychologists [ 8, 15, 28, 36].
The two randomized memory strategy trials did not include outcome data on measures of mood [ 28, 36].
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A5164 was a randomized strategy trial of "early ART" - given within 14 days of starting acute OI treatment versus "deferred ART" - given after acute OI treatment is completed.
This strategy trial did not demonstrate a significant result in the primary outcome: an ordered categorical endpoint at one year that combines clinical and virologic outcomes.
Design Randomised controlled, open label, non-inferiority strategy trial.
Secondary analysis from a randomised antibiotic strategy trial (the Procalcitonin And Survival Study).
To investigate if the effect varies by the type of strategy, trial setting and healthcare area.
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