NIH- vs FDA-Regulated Clinical Trials

Some Statistical Process Differences

When transitioning from an NIH-funded clinical trial to an FDA-regulated clinical trial, biostatisticians face new layers of regulatory oversight and specific procedural requirements. While the statistical principles and modeling techniques may be similar, the rigor of documentation, validation, and adherence to regulations within FDA-regulated trials introduces unique challenges. [Read More]

Auxiliary variables

basics

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Missing data is really an incredible area of research. It occurs in most areas of the applied sciences and knowledge of missing data can function sort of as a repair kit - so that you can avoid losing additional information when handling missingness. We can actually use missing data theory... [Read More]