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Research Outline
Prepared for Cara O. | Delivered February 22, 2020
Diagnostic Trials FDA
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Goals
We will identify and detail the role of the FDA in diagnostic clinical trials.
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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
v
i
t
r
o
diagnostic (IVD) regulations
, an
IVD devices labeling requirements
, and an
IVD guidelines document
.
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