Calculate Design Parameters for Biomarker Validation Studies
achievable.se.sp(): target sensitivity and specificity for a retrospec...
argmin Argmin function for a vector.
binom.confint
%&% string concatenation
NNT.from.pv
NNT.from.sesp
NNT.to.pv
NNT.to.sesp
Plan a biomarker validation study by focusing on desired clinical acti...
NNTintervalsProspective
NNTintervalsRetrospective
pv.from.sesp
ROCplots
run
runCombinePlots
runElicit
sesp.from.pv.feasible
sesp.from.pv
setVerboseCatOption
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.