cardiology_ldl_config.json

{
  "trial_id": "HLT003-CARD-CONT-001",
  "trial_name": "Phase III RCT \u2014 LDL-C Reduction with Lipid-Lowering Therapy",
  "sponsor": "XpertSystems Pharma LLC",
  "n_participants": 800,
  "trial_phase": "III",
  "blinding": "DOUBLE",
  "randomization": "STRATIFIED",
  "n_sites": 30,
  "arms": [
    {
      "arm_id": 0,
      "label": "Placebo",
      "randomization_weight": 1,
      "treatment_effect_cohens_d": 0.0,
      "ae_multiplier": 1.0
    },
    {
      "arm_id": 1,
      "label": "Drug A 50mg",
      "randomization_weight": 1,
      "treatment_effect_cohens_d": 0.4,
      "ae_multiplier": 1.6
    },
    {
      "arm_id": 2,
      "label": "Drug A 100mg",
      "randomization_weight": 1,
      "treatment_effect_cohens_d": 0.75,
      "ae_multiplier": 2.2
    }
  ],
  "therapeutic_area": "Cardiology",
  "endpoint_type": "CONTINUOUS",
  "endpoint_name": "LDL-C Reduction (mg/dL)",
  "endpoint_unit": "mg/dL",
  "baseline_mean": 148.0,
  "baseline_sd": 30.0,
  "placebo_change_mean": -8.0,
  "residual_sd_factor": 0.35,
  "visit_schedule": [
    -2,
    0,
    1,
    2,
    4,
    8,
    12,
    16,
    20,
    24,
    28
  ],
  "dropout_mcar_rate": 0.04,
  "dropout_mar_baseline_logit": -3.5,
  "dropout_mar_severity_coef": 0.025,
  "dropout_mar_age_coef": 0.015,
  "dropout_mar_arm_coef": 0.4,
  "dropout_mnar_fraction": 0.15,
  "ae_base_rate_per_patient": 3.2,
  "ae_active_arm_increment": 1.5,
  "ae_grade_probs_placebo": [
    0.45,
    0.32,
    0.16,
    0.05,
    0.02
  ],
  "ae_grade_probs_active": [
    0.38,
    0.3,
    0.2,
    0.08,
    0.04
  ],
  "subgroups": {
    "biomarker_positive_fraction": 0.42,
    "biomarker_treatment_interaction": 0.2,
    "elderly_fraction": 0.28,
    "elderly_ae_multiplier": 1.3
  },
  "output_filename": "cardiology_ldl_trial.csv",
  "seed": 42
}