NNTbiomarker-package

NNTbiomarker


Clarifying what performance would suffice if the test is to improve medical care makes it possible to design meaningful validation studies.


 package

Helps a clinical trial team  discuss
the clinical goals  of a well-defined biomarker with a diagnostic,
staging, prognostic, or predictive purpose.  From this discussion will
come a statistical plan for a (non-randomized) validation trial.
Both prospective and retrospective trials are supported. In a specific
focused discussion, investigators should determine the range of
"discomfort" for the NNT, number needed to treat.  The meaning of
the discomfort range, [NNTlower, NNTupper], is that within this range
most physicians would feel discomfort either in treating or withholding
treatment. A pair of NNT values bracketing that range, NNTpos and NNTneg,
become the targets of the study's design.  If the trial can demonstrate
that a positive biomarker test yields an NNT less than NNTlower,
and that a negative biomarker test yields an NNT less than NNTlower,
then the biomarker may be useful for patients. A highlight of the package
is visualization of a "contra-Bayes" theorem, which produces criteria for
retrospective case-controls studies.

NNTbiomarker-package: Plan a biomarker validation study by focusing on desired clinical actionability.

Description

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Examples