Package: PhysioTrial 0.5.1

Yusuke Matsui

PhysioTrial: Randomization, Allocation Concealment and Blinding for Clinical Trials

Provides reproducible trial-design infrastructure for simple, permuted-block, stratified-block, and Pocock-Simon minimization randomization. Sealed allocation sequences, deterministic audit fingerprints, treatment-code management, append-only unblinding logs, CONSORT/SPIRIT operations, adverse-event summaries, explicit analysis populations, missing-data hooks, and endpoint-analysis wrappers support auditable clinical-trial workflows. Deterministic CDISC SDTM-shaped and ADaM-shaped exports provide linked tabulation and analysis datasets without claiming external regulatory conformance.

Authors:Yusuke Matsui [aut, cre]

PhysioTrial_0.5.1.tar.gz
PhysioTrial_0.5.1.zip(r-4.7-any)PhysioTrial_0.5.1.zip(r-4.6-any)PhysioTrial_0.5.1.zip(r-4.5-any)
PhysioTrial_0.5.1.tgz(r-4.6-any)PhysioTrial_0.5.1.tgz(r-4.5-any)
PhysioTrial_0.5.1.tar.gz(r-4.7-any)PhysioTrial_0.5.1.tar.gz(r-4.6-any)
PhysioTrial_0.5.1.tgz(r-4.6-emscripten)
manual.pdf |manual.html✨
DESCRIPTION |NEWS
card.svg |card.png
PhysioTrial/json (API)

# Install 'PhysioTrial' in R:

install.packages('PhysioTrial', repos = c('https://x-biosignal.r-universe.dev', 'https://cloud.r-project.org'))

Bug tracker:https://github.com/x-biosignal/physiotrial/issues

Pkgdown/docs site:https://x-biosignal.github.io

On CRAN:

2.70 score 45 exports 22 dependencies

Last updated from:1d209055a7. Checks:7 NOTE, 2 OK. Indexed: yes.

Target	Result	Time
linux-devel	NOTE	156
source / vignettes	OK	189
linux-release	NOTE	158
macos-release	NOTE	122
macos-oldrel	NOTE	105
windows-devel	NOTE	100
windows-release	NOTE	98
windows-oldrel	NOTE	84
wasm-release	OK	117

Exports:adverseEvent aeSummary allocationRatio allocationTable analysisData analysisExclusions analysisParticipants Arm arms assignments auditLog blindingCodes blindingIndex blindingManager consortCounts consortDiagram defineXML endpointANCOVA endpointMMRM estimateBaselineCorrelation intentionToTreat nextAllocation Participant perProtocol powerBinary powerContinuous powerCurve randomize randomSeed responderAnalysis sampleSizeANCOVA sampleSizeBinary sampleSizeChangeScore sampleSizeContinuous sampleSizeRepeatedMeasures spiritChecklist spiritSchedule strata toADaM toSDTM Trial trialFingerprint unblind unblindingLog validateCDISC

Dependencies:abind Biobase BiocGenerics cli DelayedArray digest generics GenomicRanges IRanges lattice lifecycle Matrix MatrixGenerics matrixStats PhysioExperiment rlang S4Arrays S4Vectors Seqinfo SparseArray SummarizedExperiment XVector

Designing and running a randomized trial with PhysioTrial

Rendered fromPhysioTrial.Rmdusingknitr::rmarkdown

Last update: 2026-10-03
Started: 2026-10-03

Help page	Topics
Capture an Adverse Event	adverseEvent
Summarize Adverse Events by Trial Arm	aeSummary
Allocation Ratio	allocationRatio allocationRatio,Trial-method
Allocation Counts	allocationTable allocationTable,RandomizationSequence-method
Apply an Analysis Set and Missing-Data Method	analysisData
Extract Analysis-Set Rows and Exclusions	analysisExclusions analysisParticipants analysisSetAccessors
Construct a Trial Arm	Arm
Trial Arm	Arm-class
Arm Labels	arms arms,Trial-method
Revealed Assignments	assignments assignments,RandomizationSequence-method
Randomization Audit Log	auditLog auditLog,RandomizationSequence-method
Masked Treatment Codes	blindingCodes
Bang Blinding Index	blindingIndex
Construct a Blinding Manager	blindingManager
Blinding and Treatment-Code Manager	BlindingManager-class
CONSORT Node Counts	consortCounts
CONSORT Participant-Flow Diagram	consortDiagram
Create a Deterministic define.xml Metadata Stub	defineXML
ANCOVA Endpoint Analysis	endpointANCOVA
MMRM Endpoint Analysis	endpointMMRM
Estimate the baseline-outcome correlation (for ANCOVA planning)	estimateBaselineCorrelation
Intention-to-Treat Analysis Set	intentionToTreat
Reveal the Next Allocation	nextAllocation nextAllocation,RandomizationSequence-method
Construct a Trial Participant	Participant
Trial Participant	Participant-class
Per-Protocol Analysis Set	perProtocol
Power of a two-arm binary endpoint at a given sample size	powerBinary
Power of a two-arm continuous endpoint at a given sample size	powerContinuous
Power curve over a range of sample sizes or effect sizes	powerCurve
Concealed Randomization Sequence	RandomizationSequence-class
Generate a Concealed Randomization Sequence	randomize
Captured Randomization Seed	randomSeed randomSeed,RandomizationSequence-method
MDC/MCID Responder Analysis	responderAnalysis
Sample size for a baseline-adjusted (ANCOVA) continuous endpoint	sampleSizeANCOVA
Sample size for a two-arm binary / responder endpoint	sampleSizeBinary
Sample size for a change-from-baseline continuous endpoint	sampleSizeChangeScore
Sample size for a two-arm continuous endpoint	sampleSizeContinuous
Sample size for a repeated-measures continuous endpoint	sampleSizeRepeatedMeasures
SPIRIT 2013 Protocol Checklist	spiritChecklist
SPIRIT Schedule of Events	spiritSchedule
Trial Strata	strata strata,Trial-method
Export Trial Analysis Sets to ADaM-Shaped Data	toADaM
Export Trial Data to CDISC SDTM-Shaped Domains	toSDTM
Construct a Randomized Trial	Trial
Randomized Trial Definition	Trial-class
Trial Object Fingerprint	trialFingerprint trialFingerprint,BlindingManager-method trialFingerprint,RandomizationSequence-method
Record an Unblinding Event	unblind
Unblinding Log	unblindingLog
Validate a CDISC-Shaped Export	validateCDISC

Package: PhysioTrial 0.5.1

PhysioTrial: Randomization, Allocation Concealment and Blinding for Clinical Trials

Citation

Development and contributors

Readme and manuals

Help Manual

Usage by other packages (reverse dependencies)