Assessing Response Profiles from Incomplete Longitudinal Clinical Trial Data Under Regulatory Considerations
Assessing Response Profiles from Incomplete Longitudinal Clinical Trial Data Under Regulatory Considerations
Treatment effects are often evaluated by comparing change over time in outcome measures. However, valid analyses of longitudinal data can be problematic, particularly when some data are missing for reasons related to the outcome. In choosing the primary analysis for confirmatory clinical trials, regulatory agencies have for decades favored the …