discrete-event simulation in clinical trials - Institut für Statistik ...
discrete-event simulation in clinical trials - Institut für Statistik ...
discrete-event simulation in clinical trials - Institut für Statistik ...
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Realistic <strong>simulation</strong> by means of <strong>discrete</strong> envents<br />
Hospital 1<br />
Pacient<br />
…<br />
Hospital n<br />
Total poblation considered<br />
Eligible for the study<br />
Non eligible for the study<br />
Registered on the study<br />
Reflected for the study<br />
Ramdomized<br />
Study treatment assignation<br />
No randomized<br />
Alternativ assignation treatment<br />
Withdrawn<br />
Drop out<br />
Que<strong>in</strong>g dur<strong>in</strong>g visits<br />
Hospital i<br />
T 1<br />
= W(β=2, λ, γ =0)<br />
0 moths<br />
T 2<br />
= fix<br />
2 months+/- 10 days<br />
+/- 10 days<br />
4 months<br />
+/- 10 days<br />
6 months<br />
+/- 10 days<br />
8 meses<br />
Holydays / weekends<br />
N(0, 10)<br />
+/- 10 days<br />
10 months<br />
Time flow<br />
Y ( u n i d a d e s )<br />
Y (unidades)<br />
Riesgo AA<br />
10,3<br />
10,25<br />
10,2<br />
10,15<br />
16<br />
15<br />
14<br />
13<br />
12<br />
11<br />
10<br />
0 2 4 6 8 10<br />
1,2<br />
1<br />
0,8<br />
0,6<br />
0,4<br />
0,2<br />
Pacebo (Conceptual)<br />
10,1<br />
0 2 4 6 8 10<br />
Pacebo (Conceptual)<br />
50 mg (Conceptual)<br />
100 mg (Conceptual)<br />
Placebo (Conceptual)<br />
50 mg (Conceptual)<br />
Modelo de enfermedad<br />
Tiempo (meses)<br />
100 mg (Conceptual)<br />
Atribute variation<br />
Modelo de enfermedad<br />
Tiempo (meses)<br />
0<br />
0 5 10 15 20 25<br />
Tiempo (meses)<br />
Dosis de máximo efecto<br />
Dosis óptima<br />
Complete cl<strong>in</strong>ical trial<br />
Models<br />
Simulation:<br />
•Var between-patients,<br />
•Var <strong>in</strong>ter-patient<br />
•Global error<br />
Disease sub-model<br />
Efficacy<br />
submodel<br />
Safety submodel<br />
27
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