Generate realistic clinical trial synthetic data including study definitions, sites, subjects, visits, adverse events, efficacy assessments, and disposition. Use when user requests: clinical trial data, CDISC/SDTM/ADaM datasets, trial cohorts (Phase I/II/III/IV), FDA submission test data, or specific therapeutic areas like oncology or biologics/CGT.
Generate realistic clinical trial data including study definitions, subjects, visits, adverse events, efficacy assessments, and CDISC-compliant output.
TrialSim is the clinical trial data engine of HealthSim. It creates synthetic trial data that follows regulatory standards—proper SDTM domains, MedDRA-coded adverse events, LOINC-coded labs, and realistic enrollment patterns across multi-site, multi-country trials.
Whether you need a small Phase 1 dose-escalation study or a large Phase 3 pivotal trial with SDTM/ADaM output, TrialSim generates data suitable for testing EDC systems, statistical programming, and regulatory submission workflows.
Simple:
Generate a Phase 3 oncology trial with 200 subjects
Generate adverse events for an immunotherapy trial
SDTM domains:
Generate DM domain for 50 subjects as SDTM
Generate AE domain with MedDRA coding
With output format:
Generate a Phase II trial as SDTM datasets
Generate analysis-ready data as ADaM
See hello-healthsim examples for detailed examples with expected outputs.
| Capability | Description | Skill Reference | |------------|-------------|-----------------| | Study Definition | Protocol, arms, visit schedules | SKILL.md | | Phase 1 | Dose escalation, MTD, 3+3, BOIN, CRM | phase1-dose-escalation.md | | Phase 2 | Proof of concept, Simon's two-stage | phase2-proof-of-concept.md | | Phase 3 | Pivotal registration trials | phase3-pivotal.md | | SDTM Domains | DM, AE, VS, LB, CM, EX, DS, MH | domains/ | | Therapeutic Areas | Oncology, CV, CNS, CGT | therapeutic-areas/ | | Real World Evidence | Synthetic controls, external comparators | rwe/ |
| Phase | Key Elements | Skill | |-------|--------------|-------| | Phase 1 | First-in-human, dose escalation, MTD, DLTs | phase1-dose-escalation.md | | Phase 2 | Proof of concept, dose-ranging, futility | phase2-proof-of-concept.md | | Phase 3 | Pivotal, registration, NDA/BLA enabling | phase3-pivotal.md |
| Domain | Purpose | Skill | |--------|---------|-------| | DM | Subject demographics, treatment arms | domains/demographics-dm.md | | AE | Adverse events with MedDRA | domains/adverse-events-ae.md | | VS | Vital sign measurements | domains/vital-signs-vs.md | | LB | Laboratory results with LOINC | domains/laboratory-lb.md | | CM | Concomitant medications with ATC | domains/concomitant-meds-cm.md | | EX | Study drug exposure | domains/exposure-ex.md | | DS | Subject disposition | domains/disposition-ds.md | | MH | Medical history | domains/medical-history-mh.md |
| Format | Request | Use Case | |--------|---------|----------| | JSON | (default) | API testing, EDC integration | | CDISC SDTM | "as SDTM" | Regulatory submission | | CDISC ADaM | "as ADaM" | Statistical analysis | | Star Schema | "as star schema" | BI dashboards, DuckDB | | CSV | "as CSV" | Spreadsheet analysis |
| Product | Integration | Example | |---------|-------------|---------| | PatientSim | Patient → Subject | Cancer patient enrolls in trial | | PopulationSim | Geography → Feasibility | County data → Site selection, diversity | | NetworkSim | Provider → Investigator | Site PI with credentials | | MemberSim | Standard of care claims | SOC claims during trial |
When planning trials, TrialSim uses real population data for evidence-based feasibility:
Identify top 5 US counties for a Phase III NASH trial based on patient availability
This provides:
See SKILL.md for full integration details.
For complete generation parameters, examples, and validation rules, see:
TrialSim generates synthetic trial data only. Never use for actual regulatory submissions.
npx skills add mark64oswald/healthsim-trialsim下载完整 Skill 目录，包含 SKILL.md 及所有相关文件
Category:health-wellness