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3 years ago

Clinical Research Experience

Clinical Research Experience

Review underlying

Review underlying assumptions for statistical power during the trial • Assess overall rates of the main clinical outcomes (blinded to allocated treatment) • Assess impact of compliance to allocated treatment on risk factor levels (for example unblinded differences in lipids or BP) • Modify study duration, number of events and/or pre-specified outcomes (blinded to effects of allocation on clinical outcomes)

FDA draft guidance: Adaptive design clinical trials for drugs and biologics “Statistical bias can be introduced into adaptive design studies that make modifications based on interim analyses of a biomarker or an intermediate clinical endpoint thought to be related to the study final endpoint even though the final study analysis uses a clinical efficacy endpoint. This is because of the correlation between the biomarker and final study endpoint.” Not true: assessing the effect on a biomarker (such as blood lipids or pressure) does NOT introduce bias (ie, does not inflate type 1 error)

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