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In one arm of a study called the Fracture Intervention Trial, or FIT, sponsored by Merck and involving about 2,000 women ages 55 to 81 with an existing vertebral fracture, Fosamax cut the risk of a new vertebral fracture by about half compared with a placebo.
The Microbicide Trials Network (MTN), which is funded by the U.S. National Institutes of Health, today announced that it decided to stop one arm of a study involving more than 5000 women in South Africa, Zimbabwe, and Uganda.
When one arm of a study contained no events, 0.5 was added to all cells of the two-by-two table [ 16].
A particular issue with the assessment of the studies was that the phrase 'walking group' often related to a walking arm of a study, or a group within a trial that could walk, and not a 'walking group' per se.
In the placebo arm of a study of 32 patients who died from IPF-related causes, Martinez et al. [ 86] reported that 47% suffered an acute deterioration, and 27% of the acute deteriorations were associated with infection.
Having an ethicist on the data management committee which has oversight of the emerging data; data management committees may have to consider issues such as the welfare of patients in the arm of a study which is showing less benefit.
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This process ensures that underlying risks are randomly distributed between or among the arms of a study, thus enabling an internally valid comparison of the outcome of interest.
Arrays of equations will be introduced, in order to simulate, simultaneously, several dosing arms of a study, for example.
Thus, predictive biomarker tests that are used to balance arms of a study or to select patients for enrollment into a clinical study are under the purview of both the CMS and the U.S. FDA.
When a predictive marker will be used to direct patient enrollment or to balance arms of a study, the assay will need to be performed in a Clinical Laboratory Improvement Amendments (CLIA) laboratory.
In fact, the FDA considers any test used to direct patient treatment (including selecting patients for enrollment or balancing arms of a study) to be an IVD device that must be reviewed by the FDA [ 17].
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com