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Adaptive seamless trial designs, combining the learning and confirming cycles of drug development in a single trial, have gained popularity in recent years. Adaptations may include dose selection, sample size re‐estimation and enrichment of the study population. Despite methodological advances and recognition of the potential efficiency gains such designs offer, their implementation, including how...
Random coefficient (RC) models are commonly used in clinical trials to estimate the rate of change over time in longitudinal data. Trials utilizing a surrogate endpoint for accelerated approval with a confirmatory longitudinal endpoint to show clinical benefit is a strategy implemented across various therapeutic areas, including immunoglobulin A nephropathy. Understanding conditional power (CP) and...
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