Integrated disease information system

• US 6,108,635 A
• Filed: 04/30/1997
• Issued: 08/22/2000
• Est. Priority Date: 05/22/1996
• Status: Expired due to Fees

• Current Assignee: Interleukin Genetics Incorporated (Orig3n, Inc.)
• Original Assignee: Interleukin Genetics Incorporated (Orig3n, Inc.)
• Inventors: Moehle, Christopher J., Herren, L. Tandy, Moore, Debra J., Fink, Pamela K., Kornman, Kenneth S.
• Primary Examiner(s): MacDonald, Allen R.
• Assistant Examiner(s): Irshadullah, M.
• Application Number:
  US08/858,200
• Time in Patent Office: 1,210 Days
• Field of Search: 705/2, 705/3, 705/4, 600/300, 364/578, 128/200.3, 530/391.7
• US Class Current: 705/2
• CPC Class Codes: G06Q 10/10 Office automation; Time management
• CPC Class Codes: G06Q 40/08 Insurance
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 70/60 relating to pathologies

Abstract

A system including a set of software based Explorers, and a computer assisted methodology support the development of new medical interventions for diseases. The system includes Explorer modules for discovering proposed interventions, designing clinical trials, performing pharmacoeconomic analysis, and illustrating disease progression for various patients over time including creating disease progression tutorials for patients. The Explorers support a bottom-up or data driven methodology that enables a user, such as medical researcher, to mine data sources of clinical, biologic, expert or other types of data to discover, test, evaluate, and understand a proposed intervention and its impact on disease progression in different patient types. A Target Discovery Explorer assists the user in identifying leverage points in disease progression in relationship to various patient attributes and interventions, thereby identifying a proposed intervention for the desease. A Clinical Trials Explorer assists the user in designing clinical trials based through identification of combinations of patient attributes and intervention attributes that yield efficacious changes in selected disease progression measures. A Pharmacoeconomic Explorer enables the user to determine relative costs-benefits of a proposed intervention for patients, practitioners, and payers, including quality of life results for patients, practice results for practitioners, and financial payment results for payers. A Disease Progression Explorer enables the user to visually project disease progression for specified patient attributes and interventions, in order to better understand and explain the effects of an intervention on a disease for such patients and their practitioners, and to select disease progression tutorials that are directed to the specific patient attributes and their corresponding effect on disease progression over time.

Claims

1. A computer assisted method of identifying a proposed intervention for a disease, comprising the computer assisted steps of:

storing a database of biological data relating changes in biological systems to changes in disease progression of the disease, the biological data including;

data relating intercellular, intracellular, and organic changes in a biological system to changes in disease progression for a standard intervention;

patient attributes of a plurality of patient types;

intervention attributes of a plurality of interventions;

biology attributes of cellular changes or cellular attributes associated with each intervention; and

disease progression measures for a disease;

receiving user inputs of biologic parameters of a biological system;

constructing a query from the user inputs;

querying a data source with the query to determine values of disease progression measures associated with the biologic parameters, the disease progression measures selectively including;

cellular behavior parameters;

intermediate biological disease progression measures; and

clinically observable disease progression measures;

displaying the values of the disease progression measures; and

systematically querying of the data source with user input changes in the biologic parameters associated with standard interventions to identify the proposed intervention that produces disease progression measures indicative of an effective alteration of the disease.

2. A computer assisted method of designing a clinical trial for a proposed intervention for a disease, comprising the computer assisted steps of:

receiving data relating disease progression for selected patient types to different interventions with respect to clinical symptoms;

receiving an input of a proposed clinical trial design defined by a user selected of intervention attributes of a proposed intervention and patient attributes that are to be controlled during the proposed clinical trial;

producing a disease progression of values of disease progression measures for each of the proposed interventions for each of a plurality of patient types having different patient attributes by;

receiving patient attributes for a single patient of a selected patient type;

determining values of disease progression measures for the patient as a function of the patient attributes and the proposed intervention and standard interventions; and

displaying the values of the disease progression measures and patient attributes for each of the interventions, to assist in identifying patient attributes for which the proposed intervention provides an efficacious result on the disease progression relative to other interventions.

3. The method of claim 2, wherein the disease progression measures include at least one of:

cellular data descriptive of disease progression;

intermediate biologic data descriptive of the disease progression; and

clinically observable symptoms of the disease progression.

4. The method of claim 2, further comprising:

storing an expert knowledge base relating values of disease progression measures to selected anatomical representations of clinically observable symptoms of disease progression on a human body;

selecting from the knowledge base at least one anatomical representation of the disease progression measures in response to the patient attributes; and

graphically displaying the selected anatomical representation(s) of the disease progression measures.

5. The method of claim 2, wherein determining values of disease progression measures further comprises:

receiving patient attribute data for a plurality of patient attributes;

displaying a plurality of factorial combinations of the patient attributes, each factorial combination representing patient attributes of a single patient type;

for each of the plurality of factorial combinations of patient attributes;

querying a data source to retrieve values of disease progression measures for the combination of patient attributes; and

selectively displaying the values of the disease progression measures for patient attributes.

6. The method of claim 5, further comprising:

displaying correlations between the plurality of patient attributes and the plurality of disease progression data retrieved from the data source.

7. A computer assisted method of determining a disease progression for a proposed intervention for a disease, comprising the computer assisted steps of:

providing a database of a disease progression information relating changes in disease progression measures of changes in subcellular, cellular, organ, anatomical, or clinical attributes with respect to time and to patient attributes;

receiving a user input of specified patient attributes of a patient;

receiving disease progression measures of the disease, including a time period for projecting the disease progression for the patient;

determining from the database, the disease progression for the time period as a function of the patient attributes, and the disease progression measures; and

displaying the disease progression as changes in subcellular, cellular, tissue, or anatomical attributes of the patient.

8. The method of claim 7, wherein displaying the disease progression further comprises:

displaying the disease progression on an anatomical model of the body, showing disease progression over the time period.

9. The method of claim 7, further comprising:

providing a plurality of disease progression tutorials for the disease;

receiving patient attributes for a patient;

receiving intervention data for the proposed intervention;

receiving a user selection of a disease progression tutorial from the plurality of disease progression tutorials; and

displaying the selected disease progression tutorial.

10. The method of claim 7, further comprising:

graphically displaying the disease progression for a patient having the specified patient attributes.

11. A computer assisted method of developing an intervention for a disease, comprising the computer assisted steps of:

storing a database of biologic parameters of biological systems, disease progression measures, patient attributes, and intervention data;

receiving an input of a proposed clinical trial design defined by a user selected plurality of intervention attributes and patient attributes that are to be controlled during the proposed clinical trial;

automatically and successively altering the biologic parameters of selected biological systems and querying the database to identify a proposed intervention that affects or measures the disease progression; and

automatically and successively altering patient attributes, biologic parameters, and intervention attributes from the user selected set, and querying the database to determine a database outcome of the proposed clinical trial in terms of relationships between patient attributes, interventions, and disease progression measures.

12. The method of claim 11, further comprising:

specifying patient attributes and intervention data, and a time period for a disease progression; and

projecting from the database, disease progression measures over the time period as a function of the patient attributes and intervention data.

13. The method of claim 11, further comprising:

receiving at least one of patient attributes, practitioner attributes, and payer attributes; and

determining for a proposed intervention a pharmacoeconomic analysis of economic benefits of the proposed intervention relative to at least one standard intervention.

14. The method of claim 11, wherein identifying from the biological data a proposed intervention, further comprises:

receiving user inputs of biologic parameters of a biological system;

constructing a query from the user inputs;

querying a data source with the query to determine values of disease progression measures associated with the biologic parameters;

displaying the values of the disease progression measures; and

systematically querying of the data source with user input changes in the biologic parameters associated with standard interventions to identify the proposed intervention that produces disease progression measures indicative of an effective alteration of the disease.

15. The method of claim 14, wherein the disease progression measures are displayed as an animated sequence of images.

16. The method of claim 14, further comprising:

inferring disease progression measures associated with the input biologic parameters in response to the input biologic parameters not matching biologic parameters in the data source.

17. A computer assisted method of developing an intervention for a disease, comprising the computer assisted steps of:

identifying, from biological data of a disease progression, a proposed intervention that affects or measures the disease progression;

designing a clinical trial of the proposed intervention by analysis of a factorial combination of intervention attributes and patient attributes to determine a disease progression of the disease for a selected patient type receiving the proposed intervention;

estimating economic costs and benefits of the proposed intervention relative to standard interventions by analysis of economic and non-economic intervention costs and benefits associated with disease progression for the proposed intervention relative to economic and non-economic intervention costs and benefits associated with the disease progression for the standard interventions; and

displaying a disease progression over a specified time period for a selected patient attributes.

18. A computer assisted method of developing an intervention for a disease, comprising the computer assisted steps of:

identifying, from biological data of a disease progression, a proposed intervention that affects or measures the disease progression;

determining clinical trial data of the disease progression of the disease for a selected patient type receiving the proposed intervention by analysis of a factorial combination of intervention attributes of the proposed intervention and patient attributes; and

producing for the proposed intervention a pharmacoeconomic analysis of economic benefits of the proposed intervention relative to other interventions by analysis of economic and non-economic intervention costs and benefits associated with disease progression for the proposed intervention relative to economic and non-economic intervention costs and benefits associated with the disease progression for the standard interventions.

19. The method of claim 18, further comprising:

creating a disease progression that describes a progression of the disease for user specified patient attributes, to assist practitioners in providing the proposed intervention to a patient having the specified patient attributes.

20. A computer assisted method for therapy data analysis and creation comprising:

storing information related to therapy data for therapies and disease data for diseases, the information including one or more biologic parameters related to the therapies and biology changes from disease progression in the diseases in response to the therapies; and

receiving in a therapy discovery explorer one or more biologic parameters and analyzing the biologic parameters to create therapy data for a therapy for a disease, the therapy data relating biology change from the therapy to disease progression in the disease.

21. A computer system for assisting in the development of an intervention for a disease, comprising:

a database storing;

biological data for biological systems related to the disease;

patient type data for patients having the disease;

economic data for standard interventions applied to the disease, and

clinical data of clinical trials of standard interventions;

a target discovery module, coupled to the database to receive the biological data and patient type data, to identify a proposed intervention and produce first intervention data of effects of the proposed intervention on measures of disease progression;

a clinical trials module, coupled to the database and the target discovery module, to receive the patient type data, the first intervention data, and second intervention data of effects of standard interventions on the disease progression, and to produce clinical trial data relating selected patient populations having specific patient attributes, and disease progression for each patient type to identify patient types for which the proposed intervention has a clinically efficacious effect for inclusion in a clinical trial of the proposed intervention;

a pharmacoeconomic module, coupled to the database, and the clinical trials module, to receive the patient type data, and the economic data, to produce a pharmacoeconomic analysis of economic costs and benefits of the proposed intervention for a selected patient type relative to standard interventions; and

a disease progression module, coupled to the database to receive the biological data and patient type data, to produce, for at least one patient type having specified patient attributes, a description of disease progression in the patient type over a user specified time period.

22. The system of claim 21, further comprising:

a results database for storing intermediate result data, including;

patient attributes;

intervention attributes, for both standard interventions and the proposed intervention;

disease progression measures for the standard interventions and the proposed intervention over time, the disease progression measures selectively including cellular data and clinically observable symptoms;

cost data for the standard intervention and the proposed intervention for patients and for payers; and

pharmacoeconomic outcome data for selected patients or patient populations, practitioners, and payers.

23. The system of claim 21, wherein the pharmacoeconomic outcome data further comprises:

estimated cost of future treatments for the standard interventions and the proposed intervention;

quality of life data for the standard interventions and the proposed intervention; and

practice based results to the practitioner for providing either standard interventions or the proposed intervention.

24. A computer system for describing and presenting disease progression measures resulting from a proposed intervention for a disease, comprising:

a database storing;

biological data for biological systems related to the disease;

patient type data for patients having the disease;

disease progression measures for the disease of changes in subcellular, cellular, organ, anatomical, or clinical attributes over time for various interventions as applied to the disease in different types of patients; and

a disease progression module, coupled to the database to receive the biological data, a proposed one of the interventions, and selected patient type data, to produce, for at least one patient type having specified patient attributes, a graphic presentation of a projection of disease progression measures of the disease over time in the selected patient type resulting from the proposed intervention.

25. The system of claim 24, wherein the disease progression module further comprises:

a patient history module for receiving patient attributes of a patient and retrieving values for disease progression measures from the database descriptive of disease progression in the patient.

26. The system of claim 24, wherein the disease progression module further comprises:

a disease progression evaluation module that receives patient attributes for a patient, intervention data for the proposed intervention, and a time period for projecting the disease progression measures in the patient, and that displays the disease progression measures over the time period for the patient based on the patient attributes, the disease progression measures, and the intervention data.

27. The system of claim 26, wherein the disease progression evaluation module displays the disease progression on an anatomical representation of a human body or portion thereof.

28. An apparatus for therapy data analysis and creation comprising:

a data/information source for storing information related to therapy data and disease data, the stored information including one or more biologic parameters related to therapies and biology changes from disease progression in response to the therapies;

a process interface for accessing the data/information source to obtain biologic parameters; and

a therapy discovery explorer for receiving biologic parameters from the process interface and for analyzing the biologic parameters to create therapy data for a therapy, the therapy data relating biology change from the therapy to disease progression.

29. The apparatus according to claim 28, wherein the therapy discovery explorer comprises a biologic manipulation tool for producing one or more profiles of disease progression based on the one or more biologic parameters.

30. The apparatus according to claim 29, wherein the biologic manipulation tool queries the data/information source based on the one or more biologic parameters to produce the one or more profiles of disease progression.

31. The apparatus according to claim 29, wherein the biologic manipulation tool comprises a graphical user interface for entering the biologic parameters.

32. The apparatus according to claim 28, wherein the therapy discovery explorer further comprises a disease progression evaluation facility for analyzing disease progression based at least in part on information retrieved by the biologic manipulation tool from the data/information source and for developing information relating biology change and disease change.

33. The apparatus according to claim 28, wherein the therapy discovery explorer comprises a disease progression evaluation facility for analyzing one or more profiles of disease progression and developing the information relating biology change and disease change based on the profiles.

34. The apparatus according to claim 33, wherein the disease progression evaluation facility comprises target treatment development support for identifying at least one therapy.

35. The apparatus according to claim 33, wherein the disease progression evaluation facility comprises a user interface element for creating a display of the information relating biology change and disease change.

36. The apparatus of claim 28, wherein:

the data/information source further comprises a database storing;

biological data for biological systems related to the disease;

patient type data for patients having the disease; and

the therapy discovery explorer is coupled to the database to receive the biological data and patient type data, to identify a proposed intervention and produce intervention data of effects of a proposed intervention on measures of disease progression.

37. The apparatus of claim 36, wherein the therapy discovery explorer further comprises:

a biological manipulation tool for qualitatively or quantitatively altering biological parameters of a biological system to determine changes in disease progression measures; and

a biological change evaluation tool for displaying relationships between alterations in biological parameters and resulting changes in disease progression measures.

38. The apparatus of claim 37, wherein:

the biological manipulation tool;

receives user inputs of biological parameters of a biological system;

constructs a query from the user inputs;

queries a data source with the query to determine values of the disease progression measures associated with the biological parameters; and

the biological change evaluation tool displays the values of the disease progression measures in relationship to the input biological parameters.

39. The apparatus of claim 38, wherein:

the data/information source comprises a database storing;

biologic parameters for biological systems related to a disease;

disease progression measures for the disease over time;

patient attribute data for various patient types having the disease;

intervention data descriptive of standard interventions and a proposed intervention; and

the clinical trials explorer is coupled to the database, to receive selected patient attributes, selected biologic parameters, and selected intervention data, for querying the database to identify combinations of patient attributes and intervention for which the proposed intervention has a clinically efficacious effect on the disease progression measures, for designing a clinical trial of selected patient attributes, biologic parameters, and intervention data.

40. The apparatus of claim 39, wherein the clinical trials explorer further comprises:

a patient type efficacy module that receives the patient attributes for a single patient type, and outputs the disease progression measures for the patient type as a function of each of a plurality of interventions, including the proposed intervention and other interventions; and

a clinical trial design module that receives a plurality of distinct patient attributes, biological parameters, and intervention data, and queries the database with respect selected combinations of patient attributes, each selected combination of patient attributes representing a patient type, to determine disease progression measures for each patient type and an intervention.

41. The apparatus of claim 40, wherein the patient type efficacy module further comprises:

a clinical visualization module that receives patient attributes for a plurality of patient types and selected disease progression measures, and outputs an anatomical representation of disease progression for the selected ones of the disease progression measures and patient types as a function of the proposed intervention.

42. The apparatus of claim 40, wherein the clinical trial design module further comprises:

a trial analysis tool that receives values of selected disease progression measures, for the plurality of patient attributes, and determines and displays correlations between individual ones of the patient attributes and selected disease progression measures.

43. An apparatus for clinical trial data analysis and creation comprising:

a data/information source for storing information related to therapy data, patient data, and patient type information, the information including one or more biologic parameters related to therapies and biology changes from disease progression in response to the therapies, therapy data, and patient type information;

a process interface for accessing the data/information source to obtain biologic parameters, therapy data and patient type information; and

a clinical trials explorer for receiving biologic parameters, therapy data, and patient type information from the process interface and for analyzing the biologic parameters, therapy data, and patient type information to create clinical trial data including disease progression information from biology changes for the patient type and a therapy.

44. The apparatus according to claim 43, wherein the clinical trials explorer includes:

a patient type efficacy module for receiving patient type information and developing disease progression information based on the patient type information.

45. The apparatus according to claim 43, wherein the clinical trials explorer comprises a visualization component for displaying patient type disease progression information from rules-based analysis.

46. The apparatus according to claim 43, wherein the clinical trials explorer includes, a clinical trial design suite for determining one or more disease outcomes for one or more patient types over a specified period of time with respect to at least one therapy.

47. The apparatus according to claim 46, wherein the clinical trial design suite comprises a study design tool for developing information relating patient types and disease progression based on analysis variables.

48. The apparatus according to claim 46, wherein the clinical trial design suite comprises a trial analysis tool for developing correlations between patient variables and disease outcomes.

49. An apparatus for therapy outcome data analysis and creation comprising:

a data/information source for storing information related to therapy data for therapies, biology change from therapies, and economic and non-economic outcomes of therapies;

a process interface for accessing the data/information source to obtain the stored information; and

a pharmacoeconomic explorer for receiving the stored information from the process interface and for performing an effectiveness analysis on the received information to determine an effectiveness of a therapy as a result of biology changes from the therapy and economic and non-economic outcomes of the therapy.

50. The apparatus according to claim 49, wherein the pharmacoeconomic explorer includes at least one outcome analyzer for comparing a proposed therapy to current standard therapy for a particular constituent.

51. The apparatus according to claim 50, wherein the pharmacoeconomic explorer receives information characterizing clinical trial results to support the outcome analyzer.

52. The apparatus according to claim 49, wherein the pharmacoeconomic explorer includes, at least one outcome analyzer for developing information relating a therapy to a particular constituent outcome.

53. The apparatus according to claim 52, wherein the pharmacoeconomic explorer receives information characterizing clinical trial results to support the outcome analyzer.

54. The apparatus of claim 49 wherein:

the data/information source comprises a database storing;

patient type data for patients having the disease;

economic data for a plurality of standard interventions and the proposed intervention as applied to the disease;

disease progression measures for the disease for the plurality of standard interventions and the proposed intervention as applied to disease; and

the pharmacoeconomic explorer is coupled to the database to receive the patient type data, the economic data, and the disease progression data, to produce a pharmacoeconomic analysis of economic costs and benefits of the proposed intervention for a selected patient type relative to the standard interventions.

55. The apparatus of claim 54, wherein the pharmacoeconomic explorer further comprises:

a patient outcome analysis module that receives patient attributes for a patient type, disease attributes for a disease, and intervention data of the proposed intervention, and determines a patient outcome, including an estimated cost of the proposed intervention to the patient and a quality of life value for the patient type receiving the proposed intervention.

56. The apparatus of claim 54, wherein the pharmacoeconomic explorer further comprises:

a practitioner outcome analysis module that receives practitioner attributes for a practitioner providing the proposed intervention, and patient attributes for a patient type receiving the proposed intervention, and determines a practitioner outcome as a result of providing the proposed intervention to the patient type.

57. The apparatus of 54, wherein the pharmacoeconomic explorer further comprises:

a payer outcome analysis module that receives intervention data of the proposed intervention, future treatment data for the proposed intervention, and payer attributes of a payer providing payment for the proposed intervention, and determines a payer outcome, including an estimated cost of the proposed intervention to the payer.

58. A system for biological data analysis used in developing, testing and evaluating therapies for a disease, comprising:

at least two distinct data/information sources storing information related to at least one disease, various interventions for the at least one disease, including standard interventions, and disease progression information for at least one disease from the interventions; and

a pharmacoeconomic explorer interface integrating data received from the at least two distinct data/information sources to provide an outcome analysis of a proposed one of the interventions for a disease compared to standard interventions for the disease.

59. The system according to claim 58, wherein the at least two distinct data/information sources are chosen from the group consisting of expert knowledge databases, historical databases, clinical trial results, and computer models.

60. The system according to claim 58, wherein results produced by the pharmacoeconomic clinical trials explorer interface are a distinct data/information source which may be used by a second interface in providing reliably appraised data of a desired biological system.

61. An apparatus for therapy analysis and creation comprising:

a process interface for accessing an information source storing biological information of biological systems, the information including therapy data for therapies, biologic parameters related to the therapies and biology changes from disease progression in response to the therapies, patient type information, and economic and non-economic outcomes of the therapies, the process interface communicatively coupled to at least two explorers selected from a group consisting of;

a therapy discovery explorer that receives selected biologic parameters from the information source and develops therapy data relating biology changes to disease changes from a disease by selective alteration of biological parameters;

a clinical trials explorer that receives patient type information and therapy data, and biological parameters from the information source and develops disease progression data for the patient type and therapy therefrom; and

a pharmacoeconomic explorer that develops outcome data of a proposed therapy compared to at least one standard therapy.

62. The apparatus of claim 61, further comprising:

an information source including a plurality of different information sources, each information source providing a different type of information, including at least one of biological information, pharmaceutical information, or clinical information, economic information, or therapy information.

63. The apparatus of claim 62, wherein the plurality of information sources include at least two information sources from the group comprising:

an expert knowledge database;

a historical literature database;

a clinical trials results database; and

a computer model.

64. The apparatus of claim 62, wherein at least one of the explorers receives and processes data from at least two different information sources to develop its data.

65. The apparatus of claim 62, including at least two of the explorers, wherein the data developed by one of the explorers is an information source used by another explorer to develop its respective data.