oncology_pfs_config.json

{
  "trial_id": "HLT003-ONC-TTE-001",
  "trial_name": "Phase II RCT \u2014 Oncology Progression-Free Survival",
  "sponsor": "XpertSystems Pharma LLC",
  "n_participants": 600,
  "trial_phase": "II",
  "blinding": "OPEN",
  "randomization": "STRATIFIED",
  "n_sites": 20,
  "arms": [
    {
      "arm_id": 0,
      "label": "SoC Chemotherapy",
      "randomization_weight": 1,
      "treatment_effect_cohens_d": 0.0,
      "ae_multiplier": 1.0
    },
    {
      "arm_id": 1,
      "label": "Targeted Therapy",
      "randomization_weight": 1,
      "treatment_effect_cohens_d": 0.3,
      "ae_multiplier": 1.3
    }
  ],
  "therapeutic_area": "Oncology",
  "endpoint_type": "TTE",
  "endpoint_name": "Progression-Free Survival",
  "endpoint_unit": "weeks",
  "tte_median_placebo_weeks": 14.0,
  "tte_hazard_ratios": [
    1.0,
    0.6
  ],
  "tte_censoring_rate": 0.35,
  "treatment_weeks": 52,
  "visit_schedule": [
    -2,
    0,
    4,
    8,
    12,
    16,
    20,
    24,
    32,
    40,
    52
  ],
  "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": 4.5,
  "ae_active_arm_increment": 1.5,
  "ae_grade_probs_placebo": [
    0.3,
    0.3,
    0.25,
    0.1,
    0.05
  ],
  "ae_grade_probs_active": [
    0.25,
    0.28,
    0.27,
    0.12,
    0.08
  ],
  "subgroups": {
    "biomarker_positive_fraction": 0.35,
    "biomarker_treatment_interaction": 0.25,
    "elderly_fraction": 0.45,
    "elderly_ae_multiplier": 1.4
  },
  "output_filename": "oncology_pfs_trial.csv",
  "seed": 42
}