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Diagnostic Trials FDA


We will identify and detail the role of the FDA in diagnostic clinical trials.

Early Findings

  • According to our research, the FDA does not necessarily differentiate between normal clinical trials and diagnostic trials, which means that all diagnostic trials are regulated under their clinical trial guidelines and regulations.
  • However, the FDA does provide guidelines about the reporting of results from studies evaluating diagnostic tests.
  • A diagnostic test should always "compare a new product’s outcome (test results) to an appropriate and relevant diagnostic benchmark using subjects/patients from the intended use population; that is, those subjects/patients for whom the test is intended to be used."
  • The test's outcome must also be compared to a benchmark in order to assess the diagnostic performance of the test, with the FDA recognizing two specific benchmarks, namely 1) the comparison to a reference standard or 2) the comparison to a method or predicate other than a reference standard (non-reference standard).
  • If a non-reference standard is used for the comparison, the FDA recommends that the study "demonstrates the ability of the candidate test to agree sufficiently with the comparative method or predicate."
  • The document also contains several recommendations about the reference standard and the study population of the studies.
  • The FDA also has in vitro diagnostic (IVD) regulations, an IVD devices labeling requirements, and an IVD guidelines document.

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