{
  "trial_id": {
    "type": "string",
    "description": "Unique trial identifier string"
  },
  "n_participants": {
    "type": "integer",
    "description": "Total randomized participants (100\u201350000)",
    "range": [
      100,
      50000
    ]
  },
  "trial_phase": {
    "type": "string",
    "description": "I | II | III | IV"
  },
  "blinding": {
    "type": "string",
    "description": "OPEN | SINGLE | DOUBLE"
  },
  "randomization": {
    "type": "string",
    "description": "SIMPLE | BLOCK | STRATIFIED | MINIMIZATION"
  },
  "n_sites": {
    "type": "integer",
    "description": "Number of investigator sites (5\u2013200)"
  },
  "arms": {
    "type": "array",
    "description": "List of arm objects: {arm_id, label, randomization_weight, treatment_effect_cohens_d, ae_multiplier}"
  },
  "therapeutic_area": {
    "type": "string",
    "description": "Cardiology | Oncology | Neurology | Metabolic | Respiratory | Psychiatry | Rheumatology | Infectious Disease | Rare Disease | Ophthalmology | Dermatology | GI"
  },
  "endpoint_type": {
    "type": "string",
    "description": "CONTINUOUS | BINARY | TTE"
  },
  "endpoint_name": {
    "type": "string",
    "description": "Human-readable endpoint label"
  },
  "baseline_mean": {
    "type": "float",
    "description": "Mean baseline endpoint value (CONTINUOUS only)"
  },
  "baseline_sd": {
    "type": "float",
    "description": "SD of baseline endpoint (CONTINUOUS only)"
  },
  "placebo_change_mean": {
    "type": "float",
    "description": "Mean CFB for placebo arm at primary visit (CONTINUOUS only)"
  },
  "binary_baseline_response_rate": {
    "type": "float",
    "description": "Placebo response probability (BINARY only, 0\u20131)"
  },
  "binary_odds_ratios": {
    "type": "array",
    "description": "Odds ratios vs placebo per arm (BINARY only)"
  },
  "tte_median_placebo_weeks": {
    "type": "float",
    "description": "Median survival weeks in placebo (TTE only)"
  },
  "tte_hazard_ratios": {
    "type": "array",
    "description": "Hazard ratios vs placebo per arm (TTE only, <1 = benefit)"
  },
  "dropout_mcar_rate": {
    "type": "float",
    "description": "Base MCAR dropout probability per visit (0\u20130.05)"
  },
  "dropout_mar_arm_coef": {
    "type": "float",
    "description": "Logit coefficient for arm index in MAR dropout model"
  },
  "ae_base_rate_per_patient": {
    "type": "float",
    "description": "Expected AEs per placebo patient"
  },
  "ae_active_arm_increment": {
    "type": "float",
    "description": "Additional AEs per active arm step above placebo"
  }
}