A set of ADaM datasets are simulated to create a virtual clinical trial enviroment
CDISC standards are required for regulatory submissions to the FDA (CDER & CBER) for drugs and biologics. While CDRH does not mandate the use of CDISC standards, it strongly encourages manufacturers to adopt data and terminology standards in pre-clinical and post-market submissions to enhance consistency and improve data quality.
The Data Simulation section enables the generation of multiple simulated datasets based on CDISC standards. These datasets are invaluable for early-phase exploratory analyses, model testing, and power calculations. Whether you are exploring patient subgroups, treatment efficacy, or biomarker correlations, simulated data provides the flexibility to investigate various scenarios without relying on real-world trial data, which may be limited or unavailable in early research phases.
ADSL
- USUBJID: dynamic ITT with sample size =
- SITE: 4 sites from multinomial distribution with prob = [0.2, 0.2, 0.3, 0.3]
- SEX: gender samples from a binomial distribution (p =
) - AGE: integer samples from a uniform distribution
- HEIGHT [CM]: integer samples from a uniform distribution
- WEIGHT [KG]: integer samples from a uniform distribution
- BMI [
]: Range from to - FLG1: 2 groups from a binomial distribution (p =
) - TRTEMFL: Treatment vs Control from a binomial distribution (p =
)
ADLB
ADLB contains the information of
endpoints: - by
vistis: - with retention rates: