Design assistance for clinical trial protocols

• US 20040249664A1
• Filed: 06/05/2003
• Published: 12/09/2004
• Est. Priority Date: 06/05/2003
• Status: Active Grant

• Current Assignee: Medidata Solutions Incorporated (Dassault Systemes SA)
• Original Assignee: Fasttrack Systems, Inc.
• Inventors: Noon, Christopher, Abramowitsch, Peter L., Kahn, Michael G., Broverman, Carol A.
• Granted Patent: US 8,504,380 B2
• Time in Patent Office: Days
• US Class Current: 705/2
• CPC Class Codes: G06F 16/93 Document management systems
• CPC Class Codes: G06Q 10/067 Enterprise or organisation modelling
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 70/60 relating to pathologies

Abstract

Roughly described, a user instantiates protocol elements in a structured clinical trial protocol database and then draws from them in the development of one or more protocol related documents. The system helps the user select tasks to be performed during the study by reference to a historical database of tasks previously associated with similar protocols. The system automatically generates complex content from protocol elements m the database, and can render overlapping sets of protocol elements differently at different locations in the document. The system can automatically provide advisories indicating aspects of the document that still require completion or highlighting other issues that a sponsoring authority deems important for the document type. After all protocol elements are instantiated in the protocol database, it can then be used to drive the operation of most downstream aspects of the study.

Claims

1. A method for intelligent document formation, comprising the steps of:

instantiating a plurality of objects in a structured clinical trial protocol modeling database;

rendering first content at a first location in a document in dependence upon a first subset of said objects; and

rendering second content different from said first content, at a second location in said document in dependence upon a second subset of said objects, said second subset overlapping with said first subset.

2. A method according to claim 1, wherein said step of rendering first content includes the steps of:

converting to text a value associated with a particular object in said first subset; and

inserting said text into said document within said first content.

3. A method according to claim 2, wherein said particular object is also in said second subset,

and wherein said step of rendering second content includes the step of inserting into said document within said second content a reference to said particular object in said database.

4. A method according to claim 1, wherein said step of rendering second content includes the step of inserting into said document within said second content a reference to said particular object in said database.

5. A method according to claim 4, flier comprising the step of updating a value of said particular object as visible in said document in response to user commitment to a change made by a user in said particular object in said database.

6. A method for developing a first clinical trial protocol, comprising the steps of:

in dependence upon on a historical database, suggesting to a user a subset of tasks that are indicated in said database as having been included in previous clinical trial protocols; and

a user choosing at least one of the tasks from said subset for inclusion in said first clinical trial protocol;

instantiating, in a stored protocol modeling database for said first clinical trial protocol, at least one object identifying the task(s) chosen in said step of choosing.

7. A method according to claim 6, further comprising the step of selecting said subset of tasks in response to user-specified filtering criteria.

8. A method according to claim 7, wherein said user-specified filtering criteria narrow said subset to tasks indicated in said database as having been included in previous clinical trial protocols for at least one member of the group consisting of a user-specified therapeutic area, a user-specified group of clinical indications within a therapeutic area, and a user-specified clinical indication.

9. A method according to claim 7, wherein said user-specified filtering criteria narrows said subset to tasks indicated in said database as having been included in previous clinical trial protocols for one or more user-specified disease phases.

10. A method according to claim 7, wherein said user-specified filtering criteria narrows said subset to tasks indicated in said database as having been included in previous clinical trial protocols bearing a predetermined relationship with one or more user-specified time windows.

11. A method according to claim 7, wherein said user specified filtering criteria narrows said subset to tasks indicated in said database as having been included in previous clinical trial protocols that satisfy user-specified text-search criteria.

12. A method according to claim 6, further comprising the step of excluding from said subset of tasks all tasks whose association with said previous clinical trial protocols fail particular association strength criteria.

13. A method according to claim 12, wherein said particular association strength criteria exclude all tasks that are indicated in said historical database as having been included in no more than a predetermined percentage of previous clinical trial protocols that satisfy user-specified filtering criteria.

14. A method according to claim 12, wherein said particular association strength criteria exclude all but the N tasks indicated in said historical database as having been most frequently included in previous clinical trial protocols that satisfy user-specified filtering criteria, N being a positive number.

15. A method according to claim 6, further comprising the step of scheduling a task chosen in said step of choosing, for performance in at least one event of said first clinical trial protocol.

16. A method according to claim 6, further comprising the step of instantiating a task object corresponding to each task chosen in said step of choosing, in a structured protocol modeling database of said first clinical trial protocol.

17. A method according to claim 16, further comprising the steps of:

instantiating an event object in said protocol modeling database; and

linking said task object to said event object.

18. A method according to claim 17, wherein said step of lining comprises the step of instantiating a task-event object in said protocol modeling database, said task-event object associating said task object with said event object.

19. A method according to claim 6, further comprising the step of scheduling a task chosen in said step of choosing, for performance in at least one event of said first clinical trial protocol;

and

entering a purpose for performing said suggested task in each said at least one event.

20. A method according to claim 19, wherein said step of entering a purpose comprises the step of selecting a purpose from a list of offered purposes.

21. A method according to claim 19, wherein the purpose entered in said step of entering a purpose includes efficacy testing.

22. A method according to claim 19, further comprising the step of requiring entry of at least one of said purposes.

23. A method according to claim 19, further comprising the step of entering an outcome for association with at least one of said purposes.

24. A method according to claim 23, wherein said step of entering an outcome comprises the step of selecting an outcome from a list of offered outcomes.

25. A method according to claim 23, wherein said step of entering an outcome, for association with a particular one of said purposes, comprises the step of linking an outcome object with a task-event object that links said task chosen in said step of choosing with one of said events.

26. A method according to claim 6, further comprising the step of requiring entry of an outcome for said suggested task.

27. A method according to claim 6, wherein said step of suggesting a subset of tasks includes the step of providing a user with a cost estimate for at least one task in said subset.

28. A method according to claim 27, wherein said step of providing a user with a cost estimate comprises the step of providing said cost estimate in dependence upon a historical database that includes task costs.

29. A method for developing a first clinical trial protocol, comprising the steps of:

in dependence upon on a historical database, suggesting to a user a subset of tasks that are indicated in said database as having been associated with previous clinical trial protocols;

a user choosing a plurality of the tasks from said subset for inclusion in said first clinical trial protocol;

specifying a plurality of events for said first protocol; and

linking tasks chosen in said step of choosing, to user-selected ones of said plurality of events.

30. A method according to claim 29, further comprising the step of presenting a table having events of said plurality of events along a first dimension of said table and tasks chosen in said step of choosing, along a second dimension of said table,

and wherein said step of linking comprises the step of marking, with a user-perceptible distinguishing feature, intersections in said table at which a task is to be assigned to an event.

31. A method according to claim 30, further comprising the step of autogenerating in a clinical trial protocol document a schedule of activities table in dependence upon task-event links created in said step of linking.

32. A method according to claim 30, further comprising the step of providing, in dependence upon the linkages of tasks and events made in said step of linking, a total per-patient cost estimate for a member of the group consisting of:

(1) a trial conducted according to said first protocol; and

(2) an event in said plurality of events.

33. A method according to claim 29, wherein said step of choosing a plurality of tasks comprises the step of, in a structured protocol modeling database of said first clinical trial protocol, instantiating a task object corresponding to each task chosen in said step of choosing.

34. A method according to claim 33, further comprising the steps of:

instantiating an event object in said protocol modeling database corresponding to each of said plurality of events; and

linking user-selected ones of said plurality of task objects to user-selected ones of said event objects.

35. A method for intelligent document formation, comprising the steps of:

defining, in a structured protocol modeling database, at least one event to occur in the conduct of a particular clinical trial;

identifying, in a scan of said database, at least one particular one of said events for which no tasks are associated in said database; and

identifying said particular events to a user.

36. A method according to claim 35, further comprising the step of a user associating a task with one of said particular events after said step of identifying said particular events to a user.

37. A method according to claim 35, wherein said step of defining at least one event comprises the step of instantiating at least one event object in said database,

and wherein said step of identifying at least one particular one of said events comprises the step of, for each event object in said database, determining whether a task object is associated with the event object.

38. A method according to claim 37, further comprising the steps of:

instantiating a task object in said database; and

in said database, linking said task object to one of said event objects.

39. A method for intelligent document formation, comprising the steps of:

defining, in a structured protocol modeling database, at least one event to occur in the conduct of a fist clinical trial;

defining in said database at least one task to occur in the conduct of said first clinical trial;

forming a task-event linkage linking one of said tasks to one of said events;

identifying, in a scan of said database, at least one particular one of said task-event linkages for which no purpose is indicated in said database for performing the task of the particular task-event linkage in conjunction with the event of the particular task-event linkage; and

identifying said particular task-event linkages to a user.

40. A method according to claim 39, further comprising the step of a user associating a purpose with one of said particular task-event linkages after said step of identifying said particular task-event linkages to a user.

41. A method according to claim 39, wherein said step of defining at least one event comprises the step of instantiating at least one event object in said database,

wherein said step of defining at least one task comprises the step of instantiating at least one task object in said database,

wherein said step of forming a task-event linkage comprises the step of instantiating at least one task-event object in said database,

and wherein said step of identifying at least one particular one of said task-event linkages comprises the step of, for each of said task-event objects linked to a task object and an event object, determining whether a purpose is associated in said database with the task-event object.

42. A method for intelligent document formation, comprising the steps of:

defining, in a structured protocol modeling database, at least one task to occur in the conduct of a first clinical trial;

identifying, in a scan of said database, at least one particular one of said tasks which is not associated with any event defined in said database; and

identifying said tasks to a user.

43. A method according to claim 42, further comprising the step of a user associating one of said particular tasks with an event in said database after said step of identifying said tasks to a user.

44. A method according to claim 42, wherein said step of defining at least one task comprises the step of instantiating at least one task object in said database,

and wherein said step of identifying at least one particular one of said tasks comprises the step of, for each task object in said database, determining whether an event object is associated with the task object.

45. A method according to claim 44, further comprising the steps of:

instantiating an event object in said database; and

in said database, linking one of said task objects to one said event object.

46. A method for intelligent document formation, comprising the steps of:

defining, in a structured protocol modeling database, at least one outcome to be detected in the conduct of a first clinical trial;

identifying, in a scan of said database, at least one particular one of said outcomes for which no assessment tasks are associated in said database; and

identifying said particular outcomes to a user.

47. A method according to claim 46, further comprising the step of a user associating an assessment task with one of said particular outcomes after said step of identifying said particular outcomes to a user.

48. A method according to claim 46, wherein said step of defining at least one outcome comprises the step of instantiating at least one outcome object in said database,

and wherein said step of identifying at least one particular one of said outcomes comprises the step of, for each outcome object in said database, determining whether the outcome object has a task object associated therewith in said database.

49. A method according to claim 48, further comprising the steps of:

instantiating a task object in said database; and

in said database, linking said task object to one of said outcome objects.

50. A method for intelligent document formation, comprising the steps of:

providing a structured protocol modeling database for a clinical trial protocol;

providing a document model for a first document type, said document model including a set of at least one requirement for documents of said first document type;

instantiating a first document of said first document type, said first document including references to elements in said protocol modeling database;

scanning said first document, in dependence upon said document model, to identify any of said requirements which are not satisfied in said first document; and

reporting to a user any of said requirements identified in said step of scanning.

51. A method according to claim 50, wherein a first one of the requirements in said document model requires that at least one element of a first specified type be included in each document of said first document type.

52. A method according to claim 51, wherein said step of scanning identifies absence of any reference in said first document to an element of said first type,

and wherein said step of reporting reports to said user failure of said first requirement.

53. A method according to claim 51, wherein said step of scanning identifies no reference in said document to an element of said first type which points to an element of said first type in said protocol modeling database,

and wherein said step of reporting reports to said user failure of said first requirement.

54. A method according to claim 50, wherein a first one of said requirements comprises a requirement that at least one element of a first specified type be included in each document of said first document type and have a value assigned.

55. A method according to claim 54, wherein said step of scanning identifies no reference in said document to an element of said first type which points to a valued element of said first type in said protocol modeling database,

and wherein said step of reporting reports to said user failure of said first requirement.

56. A method according to claim 50, wherein a first one of the requirements in said document model requires that all elements required for valid export according to an external data specification be included in each document of said first document type.

57. A method according to claim 50, wherein a first one of the requirements in said document model requires that at least one document section of a first specified type be included in each document of said first document type.

58. A method according to claim 50, further comprising the step of a user correcting in said first document the non-satisfaction of one of the requirements reported to a user in said step of reporting.

59. A method for intelligent document formation, comprising the steps of:

providing a first document of a first document type;

providing a structured protocol modeling database for a clinical trial protocol, said protocol modeling database including a plurality of elements which are referenceable in a document of said first document type;

scanning said first document to identify any elements in said plurality of elements which are not referenced in said first document; and

reporting to a user any elements identified in said step of scanning.

60. A method according to claim 59, further comprising the step of a user instantiating in said first document a reference to an element reported to a user in said step of reporting.

61. A method for intelligent document formation, comprising the steps of:

providing a fist document of a first document type;

providing a structured protocol modeling database for a clinical trial protocol, said protocol modeling database including a plurality of elements which are referenceable in a document of said first document type;

scanning said first document to identify any elements in said plurality of elements which have values assigned but which are not referenced in said first document; and

reporting to a user any elements identified in said step of scanning.

62. A method according to claim 61, further comprising the step of a user instantiating in said first document a reference to an element r to a user in said step of reporting.

63. A method for intelligent document formation, comprising the steps of:

providing a first document of a first document type;

providing a structured protocol modeling database for a clinical trial protocol, said protocol modeling database being capable of incorporating elements of a plurality of element types;

scanning said first document to identify any document elements in said first document which have an element type in said plurality of element types but which do not reference any elements in said protocol modeling database of the same element type; and

reporting to a user any document elements identified in said step of scanning.

64. A method according to claim 63, further comprising the step of a user lining in said first document an element reported to a user in said step of reporting, to an element in said protocol modeling database.

65. A method for intelligent document formation, comprising the steps of:

providing a first document of a first document type;

providing a structured protocol modeling database for a clinical trial protocol, said protocol modeling database being capable of incorporating elements of a plurality of element types;

scanning said first document to identify any document elements in said first document which have an element type in said plurality of element types but which do not reference any first valued elements in said protocol modeling database of the same element type; and

reporting to a user any document elements identified in said step of scanning.

66. A method according to claim 65, wherein a particular one of the elements reported in said step of reporting is linked to a null-valued element in said protocol modeling database of the same element type,

further comprising the step of a user assigning a value to said null-valued element in said protocol modeling database.

67. A method according to claim 65, wherein a particular one of the elements reported in said step of reporting is not linked to any element in said protocol modeling database of the same element type,

further comprising the step of a linking in said first document said particular element to a particular element in said protocol modeling database.

68. A method according to claim 67, further comprising the step of assigning a value to said particular element in said protocol modeling database.

69. A method for intelligent document formation, comprising the steps of:

representing as a first XML document a document model for at least a particular document type;

representing as a second XML document a structured protocol modeling database for a clinical trial protocol;

instantiating a particular document of said particular document type, said particular document including references to elements in said protocol modeling database;

surfacing said particular document as a third XML document;

encoding a document advisory assertion as an XSL transformation, into an atomic datum, of at least one of said first, second and third XML documents;

obtaining a result of said transformation; and

reporting to a user any instances in which said result indicates that said assertion failed.