discrete-event simulation in clinical trials - Institut für Statistik ...

EXAMPLE OF MODELLING AND SIMULATION OF PHASE II-III
CLINICAL TRIAL BASED IN DRUG ACTION AND DISEASE
MODEL
‣N=144 patients (40 per dosing group (+ withdrawn):
placebo, 50 mg or 100 mg). α=0,05 y β=0,80; δ = 3,2 (Y)
‣End point: Searching the most efficient dose to treat
disease (E), but minimizing the risk of adverse events (side
effects).
‣ p-value treatments < 0,05
‣ p-valor adverse events < 0,05
‣Scope of the simulation:
Pharmacological action (PD).
Disease model (E)
Use of different parameters PK/PD of previous clinical
trials (Fase I).
Efficacy.
Safety.
Logistic subjects (number of hospitals recuiting
patients, recuiting time, time between visits, time of last
visit (end of clinical trial) withdrawn, etc).
‣Time schedule: 11 visits, every moth (0,1,2,…, 10 months).
‣First end point: Y (efficacy), RAA (Safety): Risk of adverse
event.
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