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

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The approach involved matching populations, care protocols, and costs Approach • Created a simulated population representing all diabetics over 55 years in Kaiser Permanente (CA) • Constructed trial with three groups: – Current care (based on national guidelines and realistic performance and compliance) – A-L-L regimen on top of Current Care – Reference group: 1% HbA1c reduction • Used KP’s costs for drugs, lab tests, office visits, and admissions for MIs and strokes • Set duration of simulated trial at 30 years ******** • KP’s Care Management Institute conducted an independent real trial (2 years) to evaluate A-L-L 28
29 A-L-L has a bigger effect than 1% HbA1c reduction 0.045 0.04 0.035 0.03 Average annual risk of various events Nothing HbA1c control ALL 0.025 0.02 0.015 0.01 0.005 0 MI Stroke ESRD Blind Dying
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 and 10: 9 Physiological Pathways are Repres
Page 11 and 12: 11 The Model is clinically and admi
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: A-L-L: Clinical trial simulation en
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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