1 - 6 of 6 Chapters
[The ultimate purpose of the results from a clinical trial is not to tell us precisely what happened in that trial, but, in combination with results from other trials in the drug’s clinical development program, to gain insight into likely drug responses in patients who would be prescribed the...
[The safety of a drug is assessed at all stages of its life cycle, from drug discovery through nonclinical development, preapproval clinical development, and all the time it is subsequently on the market. The focus of this chapter is safety assessment during later-stage clinical trials. When a...
[A drug must demonstrate efficacy to be given marketing approval. That is, it must provide therapeutic benefit to patients with the disease or condition of clinical concern. Efficacy is assessed in two ways: there must be compelling evidence of both statistically significant efficacy and...
[Focus in this chapter falls on two-sided confidence intervals. A two-sided confidence interval constitutes a range of values that are defined by the lower limit and the upper limit of the interval placed around the treatment effect calculated from the trial, which is now referred to as the...
[Meta-methodology facilitates the quantitative evaluation of the evidence provided by two or more individual clinical trials that have addressed the same research question. It commonly involves not only the statistical combination of summary statistics from various trials (study-level data), but...
[Benefit–risk estimation is a key facet of decision-making at both the regulatory (public health) level and the level of individual patient pharmacotherapy. It requires consideration of both benefit and risk. For a drug to receive regulatory approval, the regulatory agency must find a drug to...
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