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Clinical Trial CONSORT Flow Data

Source: R/data-clinical-trial-flow.R
clinical_trial_consort_data.Rd

Realistic simulated dataset for a Phase III randomized controlled trial (RCT) with multiple exclusion stages. Designed for testing the consortdiagram function and demonstrating CONSORT 2010 compliant flow diagrams.

Usage

clinical_trial_consort_data

Format

A data frame with 500 rows and 17 columns:

participant_id

Unique participant identifier (PT-0001 to PT-0500)

age

Age in years (mean=62, sd=12)

sex

Sex (Male/Female)

age_exclusion

Screening exclusion reason: age criteria violations

performance_exclusion

Screening exclusion reason: ECOG performance status or organ function issues

comorbidity_exclusion

Screening exclusion reason: severe comorbidity or prior malignancy

consent_exclusion

Enrollment exclusion reason: consent-related issues

eligibility_exclusion

Enrollment exclusion reason: eligibility re-assessment failures

treatment_arm

Randomized treatment assignment (Treatment A/Treatment B)

allocation_exclusion

Post-randomization exclusion: intervention not received

followup_loss

Follow-up exclusion reason: lost to follow-up or moved

followup_death

Follow-up exclusion reason: death or withdrawal

analysis_exclusion

Analysis exclusion reason: missing data or protocol violations

outcome_response

Treatment outcome (Complete/Partial Response, Stable/Progressive Disease)

Source

Generated using data-raw/create_clinical_trial_flow_data.R (seed: 20251005)

Details

This dataset simulates a realistic Phase III clinical trial with:

  • 500 participants initially assessed for eligibility

  • 20\

  • 10\

  • 1:1 randomization to Treatment A vs Treatment B

  • 5\

  • 12\

  • 3\

  • Final retention: 58.4\

Exclusion variables use NA for participants who continued to the next stage. Non-NA values indicate the specific exclusion reason at that stage.

Usage

This dataset demonstrates all features of the consortdiagram function:

  • Multiple exclusion stages (screening, enrollment, allocation, follow-up, analysis)

  • Multiple exclusion reasons per stage

  • Randomized treatment arms

  • Realistic retention rates

  • Detailed exclusion reasons for CONSORT compliance

References

Schulz KF, Altman DG, Moher D. (2010). CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ, 340:c332.

Ots R. (2024). CONSORT diagrams in R using patient-level data. https://www.riinu.me/2024/02/consort/

See also

observational_study_flow_data, multicenter_trial_data

Examples

if (FALSE) { # \dontrun{
# Load data
data(clinical_trial_consort_data)

# View structure
str(clinical_trial_consort_data)

# Summary statistics
summary(clinical_trial_consort_data)

# Count participants at each stage
n_assessed <- nrow(clinical_trial_consort_data)
n_screening_excl <- sum(!is.na(clinical_trial_consort_data$age_exclusion) |
                        !is.na(clinical_trial_consort_data$performance_exclusion) |
                        !is.na(clinical_trial_consort_data$comorbidity_exclusion))
n_randomized <- sum(!is.na(clinical_trial_consort_data$treatment_arm))
n_analyzed <- sum(!is.na(clinical_trial_consort_data$outcome_response))

cat("Assessed:", n_assessed, "\n")
cat("Screening excluded:", n_screening_excl, "\n")
cat("Randomized:", n_randomized, "\n")
cat("Analyzed:", n_analyzed, "\n")
} # }