IP Library Patent Application 11503393
Patent Application
App. No. 11/503,393

Dynamic healthcare modeling

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Quick Facts
Patent No.
US None
App. No.
11/503,393
Abstract

A method for simulating a clinical trial includes: selecting a trial procedure for a simulated trial corresponding to the clinical trial; generating a population of subjects for the simulated trial; searching the population of subjects to determine acceptable subjects for the simulated trial; selecting subjects for the simulated trial from the acceptable subjects; simulating the trial procedure for the selected subjects; and collecting trial data for the simulated trial from the simulated trial procedure.

Claims (88)

1 . A method for simulating a clinical trial, comprising:

selecting a trial procedure for a simulated trial corresponding to the clinical trial;

generating a population of subjects for the simulated trial;

searching the population of subjects to determine acceptable subjects for the simulated trial;

selecting subjects for the simulated trial from the acceptable subjects;

simulating the trial procedure for the selected subjects; and

collecting trial data for the simulated trial from the simulated trial procedure.

2 . A method as claimed in claim 1 , wherein selecting the trial procedure for the simulated trial includes:

determining one or more criteria for inclusion or exclusion of the subjects; and

determining one or more treatment protocols for the subjects.

3 . A method as claimed in claim 2 , wherein the one or more criteria include a range for fasting plasma glucose (FPG).

4 . A method as claimed in claim 1 , wherein generating the population of subjects for the simulated trial includes: determining one or more parameters for characterizing the subject at an initial state of the simulated trial, wherein the or more parameters satisfy a statistical criterion for a population corresponding to the clinical trial.

5 . A method as claimed in claim 4 , wherein the statistical criterion includes a coronary death rate.

6 . A method as claimed in claim 1 , wherein searching the population of subjects to determine acceptable subjects for the simulated trial includes: comparing features of subjects with criteria from the trial procedure.

7 . A method as claimed in claim 6 , wherein the criteria from the trial procedure include a positive characterization of diabetes.

8 . A method as claimed in claim 1 , wherein selecting subjects for the simulated trial from the acceptable subjects includes:

selecting a pre-determined number of subjects for the simulated trial;

confirming the selection by determining at least one statistical criterion for accepting the selected subjects; and

adjusting the selected subjects if the at least one statistical criterion is not satisfied.

9 . A method as claimed in claim 8 , wherein the at least one statistical criterion includes a characterization for the incidence of diabetes.

10 . A method as claimed in claim 1 , wherein simulating the trial procedure for the selected subjects includes:

separating the subjects into at least two groups, including a control group and a treatment group, wherein the trial procedure includes a control-group trial procedure for the control group and treatment-group trial procedure for the treatment group; and

advancing a temporal variable to determine at least one trial event specified by the trial procedure

11 . A method as claimed in claim 10 , wherein the at least one trial event includes a glucose measurement for at least one subject.

12 . A method as claimed in claim 10 , wherein the at least one trial event includes a coronary event for at least one subject.

13 . A method as claimed in claim 1 , wherein collecting trial data for the simulated trial includes recording values for fasting plasma glucose (FPG) of the subjects at a plurality of times.

14 . A method as claimed in claim 1 , further comprising:

analyzing the trial data from the simulated trial procedure to determine a comparison between the trial data and a set of clinical results from the clinical trial.

15 . A method as claimed in claim 14 , wherein the comparison includes a comparison of coronary events between the simulated trial and the clinical trial.

16 . An apparatus for simulating a clinical trial, the apparatus comprising a computer for executing computer instructions, wherein the computer includes computer instructions for:

selecting a trial procedure for a simulated trial corresponding to the clinical trial;

generating a population of subjects for the simulated trial;

searching the population of subjects to determine acceptable subjects for the simulated trial;

selecting subjects for the simulated trial from the acceptable subjects;

simulating the trial procedure for the selected subjects; and

collecting trial data for the simulated trial from the simulated trial procedure.

17 . An apparatus as claimed in claim 16 , wherein selecting the trial procedure for the simulated trial includes:

determining one or more criteria for inclusion or exclusion of the subjects; and

determining one or more treatment protocols for the subjects.

18 . An apparatus as claimed in claim 17 , wherein the one or more criteria include a range for fasting plasma glucose (FPG).

19 . An apparatus as claimed in claim 16 , wherein generating the population of subjects for the simulated trial includes: determining one or more parameters for characterizing the subject at an initial state of the simulated trial, wherein the or more parameters satisfy a statistical criterion for a population corresponding to the clinical trial.

20 . An apparatus as claimed in claim 19 , wherein the statistical criterion includes a coronary death rate.

21 . An apparatus as claimed in claim 16 , wherein searching the population of subjects to determine acceptable subjects for the simulated trial includes: comparing features of subjects with criteria from the trial procedure.

22 . An apparatus as claimed in claim 21 , wherein the criteria from the trial procedure include a positive characterization of diabetes.

23 . An apparatus as claimed in claim 16 , wherein selecting subjects for the simulated trial from the acceptable subjects includes:

selecting a pre-determined number of subjects for the simulated trial;

confirming the selection by determining at least one statistical criterion for accepting the selected subjects; and

adjusting the selected subjects if the at least one statistical criterion is not satisfied.

24 . An apparatus as claimed in claim 23 , wherein the at least one statistical criterion includes a characterization for the incidence of diabetes.

25 . An apparatus as claimed in claim 16 , wherein simulating the trial procedure for the selected subjects includes:

separating the subjects into at least two groups, including a control group and a treatment group, wherein the trial procedure includes a control-group trial procedure for the control group and treatment-group trial procedure for the treatment group; and

advancing a temporal variable to determine at least one trial event specified by the trial procedure

26 . An apparatus as claimed in claim 25 , wherein the at least one trial event includes a glucose measurement for at least one subject.

27 . An apparatus as claimed in claim 25 , wherein the at least one trial event includes a coronary event for at least one subject.

28 . An apparatus as claimed in claim 16 , wherein collecting trial data for the simulated trial includes recording values for fasting plasma glucose (FPG) of the subjects at a plurality of times.

29 . An apparatus as claimed in claim 16 , wherein the computer further includes computer instructions for:

analyzing the trial data from the simulated trial procedure to determine a comparison between the trial data and a set of clinical results from the clinical trial.

30 . An apparatus as claimed in claim 29 , wherein the comparison includes a comparison of coronary events between the simulated trial and the clinical trial.

31 . An apparatus as claimed in claim 16 , wherein the computer includes a processor with memory for executing at least some of the computer instructions.

32 . A computer-readable medium that stores a computer program for simulating a clinical trial, wherein the computer program includes instructions for:

selecting a trial procedure for a simulated trial corresponding to the clinical trial;

generating a population of subjects for the simulated trial;

searching the population of subjects to determine acceptable subjects for the simulated trial;

selecting subjects for the simulated trial from the acceptable subjects;

simulating the trial procedure for the selected subjects; and

collecting trial data for the simulated trial from the simulated trial procedure.

33 . A computer-readable medium as claimed in claim 32 , wherein selecting the trial procedure for the simulated trial includes:

determining one or more criteria for inclusion or exclusion of the subjects; and

determining one or more treatment protocols for the subjects.

34 . A computer-readable medium as claimed in claim 33 wherein the one or more criteria include a range for fasting plasma glucose (FPG).

35 . A computer-readable medium as claimed in claim 32 , wherein generating the population of subjects for the simulated trial includes: determining one or more parameters for characterizing the subject at an initial state of the simulated trial, wherein the or more parameters satisfy a statistical criterion for a population corresponding to the clinical trial.

36 . A computer-readable medium as claimed in claim 35 , wherein the statistical criterion includes a coronary death rate.

37 . A computer-readable medium as claimed in claim 32 , wherein searching the population of subjects to determine acceptable subjects for the simulated trial includes: comparing features of subjects with criteria from the trial procedure.

38 . A computer-readable medium as claimed in claim 37 , wherein the criteria from the trial procedure include a positive characterization of diabetes.

39 . A computer-readable medium as claimed in claim 32 , wherein selecting subjects for the simulated trial from the acceptable subjects includes:

selecting a pre-determined number of subjects for the simulated trial;

confirming the selection by determining at least one statistical criterion for accepting the selected subjects; and

adjusting the selected subjects if the at least one statistical criterion is not satisfied.

40 . A computer-readable medium as claimed in claim 39 , wherein the at least one statistical criterion includes a characterization for the incidence of diabetes.

41 . A computer-readable medium as claimed in claim 32 , wherein simulating the trial procedure for the selected subjects includes:

separating the subjects into at least two groups, including a control group and a treatment group, wherein the trial procedure includes a control-group trial procedure for the control group and treatment-group trial procedure for the treatment group; and

advancing a temporal variable to determine at least one trial event specified by the trial procedure

42 . A computer-readable medium as claimed in claim 41 , wherein the at least one trial event includes a glucose measurement for at least one subject.

43 . A computer-readable medium as claimed in claim 41 , wherein the at least one trial event includes a coronary event for at least one subject.

44 . A computer-readable medium as claimed in claim 32 , wherein collecting trial data for the simulated trial includes recording values for fasting plasma glucose (FPG) of the subjects at a plurality of times.

45 . A computer-readable medium as claimed in claim 32 , wherein the computer program further comprises instructions for:

analyzing the trial data from the simulated trial procedure to determine a comparison between the trial data and a set of clinical results from the clinical trial.

46 . A computer-readable medium as claimed in claim 45 , wherein the comparison includes a comparison of coronary events between the simulated trial and the clinical trial.

Assignments (6)
TERMINATION AND RELEASE OF SECURITY INTEREST IN PATENT COLLATERAL (RELEASES RF 03214/0260) Recorded Sep 2, 2016
From: WELLS FARGO BANK, NATIONAL ASSOCIATION
To: ARCHIMEDES, INC.; EVIDERA HOLDINGS, INC.; EVIDERA, INC.; EVIDERA LLC
Reel/Frame 039905/0004 →
RELEASE OF SECURITY INTEREST Recorded Jun 27, 2014
From: KAISER FOUNDATION HOSPITALS
To: ARCHIMEDES, INC.
Reel/Frame 033248/0057 →
CHANGE OF NAME Recorded Jun 20, 2014
From: ARCHIMEDES, INC.
To: EVIDERA ARCHIMEDES, INC.
Reel/Frame 033205/0859 →
PATENT SECURITY AGREEMENT Recorded Feb 5, 2014
From: EVIDERA HOLDINGS, INC.; EVIDERA, INC.; EVIDERA LLC; ARCHIMEDES, INC.
To: WELLS FARGO BANK, NATIONAL ASSOCIATION, AS AGENT
Reel/Frame 032164/0260 →
SECURITY AGREEMENT Recorded Oct 16, 2013
From: ARCHIMEDES, INC.
To: KAISER FOUNDATION HOSPITALS
Reel/Frame 031421/0398 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 30, 2006
From: SCHLESSINGER, LEONARD; EDDY, DAVID
To: ARCHIMEDES, INC.
Reel/Frame 018461/0689 →