Package: CoRpower 1.0.4

CoRpower: Power Calculations for Assessing Correlates of Risk in Clinical Efficacy Trials

Calculates power for assessment of intermediate biomarker responses as correlates of risk in the active treatment group in clinical efficacy trials, as described in Gilbert, Janes, and Huang, Power/Sample Size Calculations for Assessing Correlates of Risk in Clinical Efficacy Trials (2016, Statistics in Medicine). The methods differ from past approaches by accounting for the level of clinical treatment efficacy overall and in biomarker response subgroups, which enables the correlates of risk results to be interpreted in terms of potential correlates of efficacy/protection. The methods also account for inter-individual variability of the observed biomarker response that is not biologically relevant (e.g., due to technical measurement error of the laboratory assay used to measure the biomarker response), which is important because power to detect a specified correlate of risk effect size is heavily affected by the biomarker's measurement error. The methods can be used for a general binary clinical endpoint model with a univariate dichotomous, trichotomous, or continuous biomarker response measured in active treatment recipients at a fixed timepoint after randomization, with either case-cohort Bernoulli sampling or case-control without-replacement sampling of the biomarker (a baseline biomarker is handled as a trivial special case). In a specified two-group trial design, the computeN() function can initially be used for calculating additional requisite design parameters pertaining to the target population of active treatment recipients observed to be at risk at the biomarker sampling timepoint. Subsequently, the power calculation employs an inverse probability weighted logistic regression model fitted by the tps() function in the 'osDesign' package. Power results as well as the relationship between the correlate of risk effect size and treatment efficacy can be visualized using various plotting functions. To link power calculations for detecting a correlate of risk and a correlate of treatment efficacy, a baseline immunogenicity predictor (BIP) can be simulated according to a specified classification rule (for dichotomous or trichotomous BIPs) or correlation with the biomarker response (for continuous BIPs), then outputted along with biomarker response data under assignment to treatment, and clinical endpoint data for both treatment and placebo groups.

Authors:Stephanie Wu [aut], Michal Juraska [aut, cre], Peter Gilbert [aut], Yunda Huang [aut]

CoRpower_1.0.4.tar.gz
CoRpower_1.0.4.zip(r-4.7)CoRpower_1.0.4.zip(r-4.6)CoRpower_1.0.4.zip(r-4.5)
CoRpower_1.0.4.tgz(r-4.6-any)CoRpower_1.0.4.tgz(r-4.5-any)
CoRpower_1.0.4.tar.gz(r-4.7-any)CoRpower_1.0.4.tar.gz(r-4.6-any)
CoRpower_1.0.4.tgz(r-4.6-emscripten)
manual.pdf |manual.html
DESCRIPTION
card.svg |card.png
CoRpower/json (API)

# Install 'CoRpower' in R:
install.packages('CoRpower', repos = c('https://mjuraska.r-universe.dev', 'https://cloud.r-project.org'))

Bug tracker:https://github.com/mjuraska/corpower/issues

On CRAN:

Conda:

4.18 score 15 scripts 190 downloads 7 exports 4 dependencies

Last updated from:85f10e177a. Checks:9 OK. Indexed: yes.

TargetResultTimeFilesSyslog
linux-devel-x86_64OK133
source / vignettesOK151
linux-release-x86_64OK133
macos-release-arm64OK152
macos-oldrel-arm64OK113
windows-develOK101
windows-releaseOK104
windows-oldrelOK127
wasm-releaseOK92

Exports:computeNcomputePowerplotPowerContplotPowerTriplotROCcurveTriplotRRgradVEplotVElatCont

Dependencies:latticeMatrixosDesignsurvival

Introduction to R Package CoRpower
Set-up and notation | Without replacement sampling | Algorithm for trichotomous biomarker $S(1)$ | Without replacement sampling | Illustration: hypothetical randomized placebo-controlled VE trial | Trial design | Illustration: calculation of input parameters with computeN() | Assumptions | Number of vaccine recipients observed to be at risk at $\tau$ | Number of observed cases in vaccine recipients between $\tau$ and $\tau_{\mathrm{max}}$ | Number of observed controls in vaccine recipients between $\tau$ and $\tau_{\mathrm{max}}$ | Number of observed cases (controls) in vaccine recipients between $\tau$ and $\tau_{\mathrm{max}}$ with measured $S(1)$ | Compute $N_1, n_{cases,1}, n_{controls,1},$ and $n^S_{cases,1}$ with computeN() | Illustration: CoRpower for trichotomous (, S(1)) | Without replacement sampling | Scenario 1: vary control:case ratio (Approach 1) | Trichotomous $S(1)$, without replacement sampling | Run simulations and compute power with computePower() | Plot power curves with plotPowerTri() | Scenario 2: vary (, Sens) and (, Spec) (Approach 1) | Trichotomous (, S(1)), without replacement sampling | Scenario 3: vary (, P^{lat}_0, P^{lat}_2, P_0, P_2) (Approach 1) | Trichotomous (, S(1)), without replacement sampling | Scenario 4: vary (, \rho ) (Approach 2) | Trichotomous (, S(1)), without replacement sampling | Plot $RR_t$ vs. $RR_2^{lat}/RR_0^{lat}$ with plotRRgradVE() | Plot ROC curves with plotROCcurveTri() | Scenario 5: vary (, P^{lat}_0, P_0, P^{lat}_2, P_2 ) (Approach 2) | Trichotomous (, S(1)), without replacement sampling | Scenario 6: vary (, n_{cases,1}) (Approach 2) | Trichotomous (, S(1)), without replacement sampling | Illustration: CoRpower for binary (, S(1)) | Without replacement sampling | Scenario 7: vary (, n_{cases,1}) (Approach 2) | Binary (, S(1)), without replacement sampling | Algorithm for continuous biomarker (, S^{\ast}(1)) | Without replacement sampling | Illustration: CoRpower for continuous (, S^{\ast}(1)) | Without replacement sampling | Scenario 8: vary (, \rho ) | Continuous (, S^{\ast}(1)), without replacement sampling | Plot power curves with plotPowerCont() | Plot $VE^{lat}_{x^{\ast}}$ curves with plotVElatCont() | Scenario 9: vary (, P_{lowestVE}^{lat} ) | Continuous (, S^{\ast}(1)), without replacement sampling | Bernoulli / case-cohort sampling of (, S(1)) (or (, S^{\ast}(1))) | Illustration: CoRpower for trichotomous (, S(1)) and continuous (, S^{\ast}(1)) | Bernoulli sampling | Scenario 10: vary (, p ) (Approach 1) | Trichotomous (, S(1) ), Bernoulli sampling | Scenario 11: vary (, p ) | Continuous (, S^{\ast}(1)), Bernoulli sampling

Last update: 2019-09-27
Started: 2019-04-16

CoRpower's Algorithms for Simulating Placebo Group and Baseline Immunogenicity Predictor Data
Introduction | Algorithms for Simulating Placebo Group Data | Trichotomous (, X) and (, S(1)) Using Approach 1 | Trichotomous (, X) and (, S(1)) Using Approach 2 | Continuous (, X^) and (, S^(1)) | Algorithms for Simulating a Baseline Immunogenicity Predictor (BIP) | Trichotomous (, X, S(1),) and (, BIP) Using Approach 1 | Trichotomous (, X, S(1),) and (, BIP) Using Approach 2 | Continuous (, X^, S^(1),) and (, BIP^*)

Last update: 2019-04-17
Started: 2019-04-16