Guidance for Industry and Food and Drug Administration Staff; Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests." This guidance describes some statistically appropriate practices for reporting results from different studies evaluating diagnostic tests and identifies some common inappropriate practices. Special attention is given to describing a practice called discrepant resolution and its associated problems.