Technique for specifying the parameters of complex technical studies by using a decision tree

• US 6,643,660 B1
• Filed: 10/30/2000
• Issued: 11/04/2003
• Est. Priority Date: 10/30/2000
• Status: Expired due to Fees

• Current Assignee: Toxweb Incorporated
• Original Assignee: Toxweb Incorporated
• Inventors: Miller, James Arthur, Lanfear, Dennis M.
• Primary Examiner(s): KINDRED, ALFORD W
• Application Number:
  US09/702,198
• Time in Patent Office: 1,100 Days
• Field of Search: 707/1, 707/6-7, 707/100, 707/103.R, 707/514, 706/45-47, 717/100
• US Class Current: 1/1
• CPC Class Codes: G06Q 10/10 Office automation; Time management
• CPC Class Codes: G06Q 30/08 Auctions

Abstract

The present specification, discloses a method, apparatus, and article of manufacture for specifying the design and execution related parameters of a technical study by creating and using a decision tree. In accordance with an embodiment of the present invention, a decision tree is created that has interdependent decision nodes. One or more decision choices is associated with each interdependent decision nodes. The interdependent decision nodes are ordered in a hierarchical manner such. that a selection of one of the decision choices dynamically and functionally determines the manner in which a subsequent decision choice is affected. This embodiment of the present invention has utility for objectively defining study parameters and thereby substantially stream lining the design specification process for complex technical studies.

Claims

1. A method of creating a decision tree for use with a technical study design specification, wherein the technical study design specification is based on toxicology studies, comprising:

at a computer,

(a) identifying a plurality of possible parameters that can be used to objectively describe the technical study;

(b) developing one or more hierarchical and causal relationships between the parameters by using expert knowledge;

(c) assigning each parameter to one or more interdependent decision nodes, and

(d) ordering the interdependent decision nodes in a hierarchical manner, such that a decision choice at one node dynamically and functionally determines the manner in which a subsequent decision choice is affected at a subsequent node.

2. A method of creating a decision tree for use with a technical study design specification, wherein the technical study design specification is based on a pharmaceutical drug research, development and commercialization activity, comprising:

at a computer,

(a) identifying a plurality of possible parameters that can be used to objectively describe the technical study;

(b) developing one or more hierarchical and causal relationships between the parameters by using expert knowledge;

(c) assigning each parameter to one or more interdependent decision nodes; and

(d) ordering the interdependent decision nodes in a hierarchical manner, such that a decision choice at one node dynamically and functionally determines the manner in which a subsequent decision choice is affected at a subsequent node.

3. A method of using a decision tree to generate a technical study design specification, comprising:

at a computer,

(a) storing the decision tree, wherein the decision tree includes at least two interdependent nodes, and wherein each interdependent node represents a different aspect of the technical study;

(b) transmitting the decision tree or its functional representation to a client computer;

(c) for one of the interdependent nodes of the decision tree, displaying the interdependent node on a monitor that is attached to the client computer, wherein displaying the interdependent node comprises displaying one or more possible choices for that interdependent node;

(d) receiving at least one user-specified choice, wherein the user-specified choice is a subset of the displayed choices;

(e) based on the received user-specified choices, dynamically and functionally affecting a pre-defined number of possible choices from any other interdependent nodes; and

(f) continuing steps (b)-(f) until the possible choices for each node have been displayed on the monitor.

4. The method of claim 3, further comprising:

before step (a), at a computer, creating the decision tree by;

(i) identifying a plurality of possible parameters that can be used to objectively describe the technical study;

(ii) developing one or more hierarchical and causal relationships between the parameters by using expert knowledge;

(iii) assigning each parameter to an interdependent decision node; and

(iv) ordering the interdependent decision nodes in a hierarchical manner, such that a decision choice at one node dynamically and functionally determines the manner in which a subsequent decision choice is affected.

5. The method of claim 3, wherein the decision tree is a menudriven system that allows a user to select from two or more menu choices.

6. The method of claim 3, wherein the decision tree comprises a combination of a menu-driven system and a command-driven system, this combination allows a user to select from two or more menu choices, and the combination allows the user to enter at least one user-defined choice.

7. The method of claim 3, wherein the decision tree is a command-driven system that allows a user to enter one or more user-defined choices.

8. The method of claim 3, further comprising, at a computer, transmitting the user-specified choices for each node to a database that is stored on a data storage device which is connected to the computer.

9. The method of claim 3, wherein the technical study design specification is based on a complex technical study.

10. The method of claim 3, wherein the technical study design specification is based on a toxicology study.

11. The method of claim 3, wherein the technical study design specification is based on a pharmaceutical drug research, development and commercialization study.

12. The method of claim 3, wherein the technical study design specification is based on any sequence of objectively defined procedures or conditions.

13. A method of using a decision tree to generate a technical study design specification, comprising:

at a computer,

(a) creating a decision tree by,

(i) identifying a plurality of possible parameters that can be used to objectively describe the technical study;

(ii) developing hierarchical and causal relationships between the parameters by using expert knowledge;

(iii) assigning each parameter to an interdependent decision node;

(iv) ordering the interdependent decision nodes in a hierarchical manner, such that a decision choice at one node dynamically and functionally affects the decision choice at a subsequent node;

(b) storing the decision tree;

(c) transmitting the decision tree to a client computer;

(d) for one of the interdependent nodes of the decision tree, displaying the interdependent node on a monitor that is attached to the client computer, wherein displaying the interdependent node comprises displaying one or more possible choices for that interdependent node;

(e) receiving at least one user-specified choice, wherein the user-specified choice is a subset of the displayed choices;

(f) based on the received user-specified choices, dynamically and functionally affecting a pre-defined number of possible choices from any other interdependent nodes; and

(g) continuing steps (c)-(g) until the possible choices for each node have been displayed on the monitor.

14. The method of claim 13, wherein the decision tree is a menudriven system that allows a user to select from two or more menu choices.

15. The method of claim 13, wherein the decision tree comprises a combination of a menu-driven system and a command-driven system, this combination allows a user to select from two or more menu choices, and the combination allows the user to enter at least one user-defined choice.

16. The method of claim 13, wherein the decision tree is a command-driven system that allows a user to enter one or more user-defined choices.

17. The method of claim 13, further comprising, at a computer, transmitting the user-specified choices for each node to a database that is stored on a data storage device which is connected to the computer.

18. The method of claim 13, wherein the technical study design specification is based on a complex technical study.

19. The method of claim 13, wherein the technical study design specification is based on a toxicology study.

20. The method of claim 13, wherein the technical study design specification is based on a pharmaceutical drug technical and development and commercialization study.

21. The method of claim 13, wherein the technical study design specification is based on any sequence of objectively defined procedures or conditions.

22. An apparatus for creating a decision tree for use with a technical study design specification, wherein the technical study design specification is based on toxicology studies, comprising:

a computer; and

a computer program, performed by the computer, that (a) identifies a plurality of possible parameters that can be used to objectively describe the technical study, (b) develops one or more hierarchical and causal relationships between the parameters by using expert knowledge, (c) assigns each parameter to one or more interdependent decision nodes, and (d) orders the interdependent decision nodes in a hierarchical manner, such that a decision choice at one node dynamically and functionally determines the manner in which a subsequent decision choice is affected at a subsequent node.

23. An apparatus for creating a decision tree for use with a technical study design specification, wherein the technical study design specification is based on a pharmaceutical drug research, development and commercialization activity, comprising:

a computer; and

a computer program, performed by the computer, that (a) identifies a plurality of possible parameters that can be used to objectively describe the technical study, (b) develops one or more hierarchical and causal relationships between the parameters by using expert knowledge, (c) assigns each parameter to one or more interdependent decision nodes, and (d) orders the interdependent decision nodes in a hierarchical manner, such that a decision choice at one node dynamically and functionally determines the manner in which a subsequent decision choice is affected at a subsequent node.

24. An apparatus for using a decision tree to generate a technical study design specification, comprising:

a computer; and

a computer program, performed by the computer, that (a) stores the decision tree, wherein the decision tree includes at least two interdependent nodes, and wherein each interdependent node represents a different aspect of the technical study, (b) transmits the decision tree or its functional representation to a client computer, (c) for one of the interdependent nodes of the decision tree, displays the interdependent node on a monitor that is attached to the client computer, wherein displaying the interdependent node comprises displaying one or more possible choices for that interdependent node, (d) receives at least one user-specified choice, wherein the user-specified choice is a subset of the displayed choices, (e) based on the received user-specified choices, dynamically and functionally affects a pre-defined number of possible choices from any other interdependent nodes, and (f) continues steps (b)-(f) until the possible choices for each node have been displayed on the monitor.

25. The apparatus of claim 24, further comprising:

a computer program, performed by the computer, that, before step (a), creates the decision tree by (i) identifying a plurality of possible parameters that can be used to objectively describe the technical study, (ii) developing one or more hierarchical and causal relationships between the parameters by using expert knowledge, (iii) assigning each parameter to an interdependent decision node, and (iv) ordering the interdependent decision nodes in a hierarchical manner, such that a decision choice at one node dynamically and functionally determines the manner in which a subsequent decision choice is affected.

26. The apparatus of claim 24, wherein the decision tree is a menu-driven system that allows a user to select from two or more menu choices.

27. The apparatus of claim 24, wherein the decision tree comprises a combination of a menu-driven system and a command-driven system, this combination allows a user to select from two or more menu choices, and the combination allows the user to enter at least one user-defined choice.

28. The apparatus of claim 24, wherein the decision tree is a command-driven system that allows a user to enter one or more user-defined choices.

29. The apparatus of claim 24, further comprising, a computer program, performed by the computer, that transmits the user-specified choices for each node to a database that is stored on a data storage device which is connected to the computer.

30. The apparatus of claim 24, wherein the technical study design specification is based on a complex technical study.

31. The apparatus of claim 24, wherein the technical study design specification is based on a toxicology study.

32. The apparatus of claim 24, wherein the technical study design specification is based on a pharmaceutical drug research, development and commercialization study.

33. The apparatus of claim 24, wherein the technical study design specification is based on any sequence of objectively defined procedures or conditions.

34. An apparatus for using a decision tree to generate a technical study design specification, comprising:

a computer;

a computer program, performed by the computer, that creates a decision tree by (a) identifying a plurality of possible parameters that can be used to objectively describe the technical study, (b) developing hierarchical and causal relationships between the parameters by using expert knowledge, (c) assigning each parameter to an interdependent decision node, (d) ordering the interdependent decision nodes in a hierarchical manner, such that a decision choice at one node dynamically and functionally affects the decision choice at a subsequent node; and

a computer program, performed by the computer, that (a) stores the decision tree, (b) transmits the decision tree to a client computer, (c) for one of the interdependent nodes of the decision tree, displays the interdependent node on a monitor that is attached to the client computer, wherein displaying the interdependent node comprises displaying one or more possible choices for that interdependent node, (d) receives at least one user-specified choice, wherein the user-specified requirement is a subset of the displayed choices, (e) based on the received user-specified choices, dynamically and functionally affects a pre-defined number of possible choices from any other interdependent nodes, and (f) continues steps (b)-(f) until the possible choices for each node have been displayed on the monitor.

35. The apparatus of claim 34, wherein the decision tree is a menu-driven system that allows a user to select from two or more menu choices.

36. The apparatus of claim 34, wherein the decision tree comprises a combination of a menu-driven system and a command-driven system, this combination allows a user to select from two or more menu choices, and the combination allows the user to enter at least one user-defined choice.

37. The apparatus of claim 34, wherein the decision tree is a command-driven system that allows a user to enter one or more user-defined choices.

38. The apparatus of claim 34, further comprising, at a computer, transmitting the user-specified choices for each node to a database that is stored on a data storage device which is connected to the computer.

39. The apparatus of claim 34, wherein the technical study design specification is based on a complex technical study.

40. The apparatus of claim 34, wherein the technical study design specification is based on a toxicology study.

41. The apparatus of claim 34, wherein the technical study design specification is based on a pharmaceutical drug technical and development and commercialization study.

42. The apparatus of claim 34, wherein the technical study design specification is based on any sequence of objectively defined procedures or conditions.

43. An article of manufacture comprising a computer program carrier readable by a computer and embodying one or more instructions executable by the computer to perform the method of creating a decision tree for use with a technical study design specification, wherein the technical study design specification is based on toxicology studies, comprising:

at a computer,

(a) identifying a plurality of possible parameters that can be used to objectively describe the technical study;

(b) developing one or more hierarchical and causal relationships between the parameters by using expert knowledge;

(c) assigning each parameter to one or more interdependent decision nodes; and

(d) ordering the interdependent decision nodes in a hierarchical manner, such that a decision choice at one node dynamically and functionally determines the manner in which a subsequent decision choice is affected at a subsequent node.

44. An article of manufacture comprising a computer program carrier readable by a computer and embodying one or more instructions executable by the computer to perform the method of creating a decision tree for use with a technical study design specification, wherein the technical study design specification is based on a pharmaceutical drug research, development and commercialization activity, comprising:

at a computer,

(a) identifying a plurality of possible parameters that can be used to objectively describe the technical study;

(b) developing one or more hierarchical and causal relationships between the parameters by using expert knowledge;

(c) assigning each parameter to one or more interdependent decision nodes; and

(d) ordering the interdependent decision nodes in a hierarchical manner, such that a decision choice at one node dynamically and functionally determines the manner in which a subsequent decision choice is affected at a subsequent node.

45. An article of manufacture comprising a computer program carrier readable by a computer and embodying one or more instructions executable by the computer to perform the method of using a decision tree to generate a technical study design specification, comprising:

at a computer,

(a) storing the decision tree, wherein the decision tree includes at least two interdependent nodes, and wherein each interdependent node represents a different aspect of the technical study;

(b) transmitting the decision tree or its functional representation to a client computer;

(c) for one of the interdependent nodes of the decision tree, displaying the interdependent node on a monitor that is attached to the client computer, wherein displaying the interdependent node comprises displaying one or more possible choices for that interdependent node;

(d) receiving at least one user-specified choice, wherein the user-specified choice is a subset of the displayed choices;

(e) based on the received user-specified choices, dynamically and functionally affecting a pre-defined number of possible choices from any other interdependent nodes; and

(f) continuing steps (b)-(f) until the possible choices for each node have been displayed on the monitor.

46. The article of manufacture of claim 45, further comprising:

before step (a), at a computer, creating the decision tree by;

(i) identifying a plurality of possible parameters that can be used to objectively describe the technical study;

(ii) developing one or more hierarchical and causal relationships between the parameters by using expert knowledge;

(iii) assigning each parameter to an interdependent decision node; and

(iv) ordering the interdependent decision nodes in a hierarchical manner, such that a decision choice at one node functionally determines the manner in which a subsequent decision choice is affected.

47. The article of manufacture of claim 45, wherein the decision tree is a menu-driven system that allows a user to select from two or more menu choices.

48. The article of manufacture of claim 45, wherein the decision tree comprises a combination of a menu-driven system and a command-driven system, this combination allows a user to select from two or more menu choices, and the combination allows the user to enter at least one user-defined choice.

49. The article of manufacture of claim 45, wherein the decision tree is a command-driven system that allows a user to enter one or more user-defined choices.

50. The article of manufacture of claim 45, further comprising, at a computer, transmitting the user-specified choices for each node to a database that is stored on a data storage device which is connected to the computer.

51. The article of manufacture of claim 45, wherein the technical study design specification is based on a complex technical study.

52. The article of manufacture of claim 45, wherein the technical study design specification is based on a toxicology study.

53. The article of manufacture of claim 45, wherein the technical study design specification is based on a pharmaceutical drug research, development and commercialization study.

54. The article of manufacture of claim 45, wherein the technical study design specification is based on any sequence of objectively defined procedures or conditions.

55. An article of manufacture comprising a computer program carrier readable by a computer and embodying one or more instructions executable by the computer to perform the method of using a decision tree to generate a technical study design specification, comprising:

at a computer,

(a) creating a decision tree by,

(i) identifying a plurality of possible parameters that can be used to objectively describe the technical study;

(ii) developing hierarchical and causal relationships between the parameters by using expert knowledge;

(iii) assigning each parameter to an interdependent decision node;

(iv) ordering the interdependent decision nodes in a hierarchical manner, such that a decision choice at one node dynamically and functionally affects the decision choice at a subsequent node;

(b) storing the decision tree;

(c) transmitting the decision tree to a client computer;

(d) for one of the interdependent nodes of the decision tree, displaying the interdependent node on a monitor that is attached to the client computer, wherein displaying the interdependent node comprises displaying one or more possible choices for that interdependent node;

(e) receiving at least one user-specified choice, wherein the user-specified choice is a subset of the displayed choices;

(f) based on the received user-specified choices, dynamically and functionally affecting a pre-defined number of possible choices from any other interdependent nodes; and

(g) continuing steps (c)-(g) until the possible choices for each node have been displayed on the monitor.

56. The article of manufacture of claim 55, wherein the decision tree is a menu-driven system that allows a user to select from two or more menu choices.

57. The article of manufacture of claim 55, wherein the decision tree comprises a combination of a menu-driven system and a command-driven system, this combination allows a user to select from two or more menu choices, and the combination allows the user to enter at least one user-defined choice.

58. The article of manufacture of claim 55, wherein the decision tree is a command-driven system that allows a user to enter one or more user-defined choices.

59. The article of manufacture of claim 55, further comprising, at a computer, transmitting the user-specified choices for each node to a database that is stored on a data storage device which is connected to the computer.

60. The article of manufacture of claim 55, wherein the technical study design specification is based on a complex technical study.

61. The article of manufacture of claim 55, wherein the technical study design specification is based on a toxicology study.

62. The article of manufacture of claim 55, wherein the technical study design specification is based on a pharmaceutical drug technical and development and commercialization study.

63. The article of manufacture of claim 55, wherein the technical study design specification is based on any sequence of objectively defined procedures or conditions.