The authors noted that there has never been a controlled clinical trial of parachutes, and facetiously suggested that one be conducted in which subjects were randomized to jump from a plane either with or without a device.
The FDA approval comes without a controlled clinical trial, which is usually required for a regulatory OK. But in studies, Velcade clearly helped a third of multiple myeloma patients who had failed two or more previous therapies--a stunning result in such a lethal disease.
More substantial and convincing support for such a recommendation to eat cherries as a way to reduce gout flares would ideally emerge from a randomized controlled clinical trial.
The investigators are now conducting a randomized, controlled clinical trial of RAGE Control in the outpatient clinic at Boston Children's that adds a cooperative component.
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For one, the groups noted the analysis is a retrospective study, not a prospective, randomized controlled clinical trial, which many regard as a gold standard for ferreting out safety concerns.
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But a related Abbott drug, TriCor, failed to prove its benefits in a large randomized controlled clinical trial.
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In the accepted hierarchy of evidence generation, the results of a randomized, controlled clinical trial usually take precedence over other forms of evidence such as meta-analysis and observational studies.
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According to a press release, a clinical trial involving 424 patients showed tumors were controlled better by a combination of Erbitux and radiation than radiation alone.
In June, the British Medical Journal published a major analysis of all the controlled clinical trials that have so far been presented.
Packer says this is the first placebo-controlled study in acute heart failure to show a clinical benefit.
Genentech, in contrast, has insisted on large, controlled clinical studies that prove its drugs work beyond a reasonable doubt.
When big, controlled clinical trials designed to compare two medicines emerge, the results often resemble what Graham managed with a supposedly less-sensitive study.
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