Simulation of Clinical Trials with Mathematical Models ... - CBI

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Type 1 10 The Model is comprehensive Family history Sex Race/ ethnicity Age BMI Height Diabetes feature Type 2 Diabetes feature Age, sex, race/ ethnicity Weight Diabetes blood pressure factor Insulin Gliburide Insulin level treatment Insulin production Joint (Pancreas) Glucose Diabetes uptake by feature muscle Insulin efficiency (Muscle) Glucose production Insulin by liver efficiency (Liver) Normal liver glucose production Metformin UKPDS data Diet and exercise HDL LDL Triglyceride cholesterol cholesterol s Unexplained variance in OGT FPG Untreated insulin level Diabetes Smoking cardiac risk factor Mean Systolic Coronary Peripheral arterial blood artery resistance pressure pressure stenosis FPG OGT Random plasma glucose Random error and variation Care processes Fractional change in Insulin FPG Propensity to blurred vision Propensity to polyuria OGTT test Random Diabetes plasma diagnosis glucose test FPG test HbA1c test Urine ketone test To treatment Ketoacidosis models Hypoglycemia Patient takes action Blurred vision Memory Polyuria Perception Behaviors Symptoms Signs Diseases Outcomes Cardiac output Arterial compliance Pulse \ pressure Propensity to fatigue Fatigue To the To the To the To the Coronary Retinopathy Nephropath Neuropathy artery model y model model disease model Propensity to thirst Thirst
11 The Model is clinically and administratively detailed, enabling detailed costing and economic analysis Patient: • Has chest pain and presents to the ER • Receives EKG, chest x-ray, and blood tests • Is diagnosed with MI, admitted to the hospital, and given an angioplasty with drug-eluting stent • Remains in the hospital for 2.1 days and is discharged Who is reimbursed Service performed Codes Cardiologist Reimbursement MS-DRG 247: Percutaneous Cardiovascular Procedure with Consultation Read EKG Perform cardiac catheterization Drug-Eluting Stent Perform angioplasty with drug-eluting stent •2008 Medicare base payment: $10,365 CPT CPT (professional component only) CPT CPT Radiologist Read x-ray CPT (professional component only) Anesthesiologist Provide anesthesia during angioplasty RVG code and time patient is anesthetized (can be converted to a CPT) •Medicare average length of stay: 2.1 days Other physicians Inpatient consultations CPT Hospital All services performed during stay DRG
Page 1 and 2: Simulation of Clinical Trials with
Page 3 and 4: Topics • Rationale, mechanisms, a
Page 5 and 6: There are several ways to try to pr
Page 7 and 8: Topics • Rationale, mechanisms, a
Page 9: 9 Physiological Pathways are Repres
Page 13 and 14: Over 50 trials have been used to va
Page 15 and 16: The Model can enhance trial design,
Page 17 and 18: Only simulation modeling could have
Page 19 and 20: 19 This enabled generation of longi
Page 21 and 22: In simulation, the DPP trial was si
Page 23 and 24: Estimating longitudinal cost outcom
Page 25 and 26: Simulation enabled trial expansion
Page 27 and 28: A-L-L: Clinical trial simulation en
Page 29 and 30: 29 A-L-L has a bigger effect than 1
Page 31 and 32: 31 CMI Independent Evaluation (2007
Page 33 and 34: A population dataset with pre-run i
Page 35 and 36: Health and cost outcomes can be cap
Page 37 and 38: Appendix www.archimedesmodel.com ..
Page 39 and 40: Publications • Age at initiation
Page 41 and 42: 41 The validation approach is rigor
Page 43 and 44: Fraction of patients 43 The Model y
Page 45 and 46: In the DPP simulation, populations
Page 47 and 48: Cost/ QALY DPP simulation also enab
Page 49 and 50: A-L-L: The savings begin immediatel

Simulation of Clinical Trials with Mathematical Models ... - CBI

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