Assistance for clinical trial protocols

• US 8,504,380 B2
• Filed: 06/05/2003
• Issued: 08/06/2013
• Est. Priority Date: 06/05/2003
• Status: Active Grant

• Current Assignee: Medidata Solutions Incorporated (Dassault Systemes SA)
• Original Assignee: Medidata Solutions Incorporated (Dassault Systemes SA)
• Inventors: Broverman, Carol A., Kahn, Michael G., Noon, Christopher
• Primary Examiner(s): NGUYEN, HIEP VAN
• Application Number:
  US10/454,954
• Publication Number:
  US 20040249664A1
• Time in Patent Office: 3,715 Days
• Field of Search: 705/2
• 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 in 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. Alter 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 of developing a clinical trial protocol, the method comprising:

receiving, by a computing device, a request to query a historical database, said request including user-specified filtering criteria having a clinical indication, trial phase and past time window, said historical database storing a plurality of individual tasks from multiple clinical trial protocols associated with past protocol dates, each individual task of said plurality of individual tasks being categorized for a particular clinical indication and particular trial phase;

retrieving, by the computing device, a subset of individual tasks from said plurality of individual tasks based on said filtering criteria, said subset including at least a first individual task from a first clinical trial protocol and a second individual task from a second clinical trial protocol, said past protocol dates of said first clinical trial protocol and said second clinical trial protocol being within said past time window, each of the individual tasks included in said subset being associated with a numerical association strength criterion that indicates at least a predetermined strength of association of each of the individual tasks in said subset to other clinical trial protocols for the clinical indication and trial phase;

receiving, by the computing device, a selection of at least one individual task from said subset; and

creating, by the computing device, a structured protocol modeling database for instantiating at least one object of said clinical trial protocol based on said selection of the at least one individual task.

2. A method according to claim 1, wherein said user-specified filtering criteria further has text-search criteria.

3. A method according to claim 1, further comprising excluding, by the computing device, from said subset individual tasks whose association with previous clinical trial protocols fail a particular association strength criterion.

4. A method according to claim 3, wherein said particular association strength criterion excludes individual tasks from said subset 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.

5. A method according to claim 3, wherein said particular association strength criterion excludes individual tasks but an N number of individual tasks indicated in said historical database as having been most frequently included in previous clinical trial protocols that satisfy user-specified filtering criteria, said N number being a positive number.

6. A method according to claim 1, further comprising scheduling, by the computing device, one of said at least one individual task for performance in at least one event of said clinical trial protocol.

7. A method according to claim 1, further comprising instantiating, by the computing device, at least one task object corresponding to said at least one individual task in the structured protocol modeling database of said clinical trial protocol.

8. A method according to claim 7, further comprising:

instantiating, by the computing device, at least one event object in said protocol modeling database; and

linking, by the computing device, said at least one task object to said at least one event object.

9. A method according to claim 8, wherein linking comprises instantiating, by the computing device, at least one task-event object in said protocol modeling database, said at least one task-event object associating said at least one task object with said at least one event object.

10. A method according to claim 1, further comprising:

scheduling, by the computing device, one of said at least one individual task for performance in at least one event of said clinical trial protocol; and

entering, by the computing device, a purpose for performing said one of said at least one individual task scheduled for performance in said at least one event.

11. A method according to claim 10, wherein entering a purpose comprises selecting, by the computing device, a purpose from a list of offered purposes.

12. A method according to claim 11, further comprising requiring, by the computing device, entry of said purpose from said offered purposes.

13. A method according to claim 11, further comprising entering, by the computing device, an outcome for association with at least one of said offered purposes.

14. A method according to claim 13, wherein entering an outcome comprises selecting, by the computing device, an outcome from a list of offered outcomes.

15. A method according to claim 13, wherein entering an outcome, for association with a particular one of said purposes, comprises linking, by the computing device, an outcome object with a task-event object that links said at least one individual task said at least one event.

16. A method according to claim 10, wherein the purpose is efficacy testing.

17. A method according to claim 1, further comprising requiring, by the computing device, entry of an outcome for said at least one individual task.

18. A method according to claim 1, wherein retrieving said subset of individual tasks includes retrieving, by the computing device, a cost estimate for at least one of the individual tasks in said subset.

19. A method according to claim 18, wherein said cost estimate is retrieved in dependence upon a historical database that includes task costs.

20. A method of developing a clinical trial protocol, the method comprising:

receiving, by a computing device, a request to query a historical database, said request including user-specified filtering criteria having a clinical indication, trial phase and past time window, said historical database storing a plurality of individual tasks from multiple clinical trial protocols associated with past protocol dates, each individual task of said plurality of individual tasks categorized for a particular clinical indication and particular trial phase;

retrieving, by the computing device, a subset of individual tasks from said plurality of individual tasks based on said filtering criteria, at least a first individual task in said subset from a first clinical trial protocol and a second individual task in said subset from a second clinical trial protocol, said past protocol dates of said first clinical trial protocol and said second clinical trial protocol being within said past time window, each of the individual tasks included in said subset being associated with a numerical association strength criterion that indicates at least a predetermined strength of association of each of the individual tasks in said subset to other clinical trial protocols for the clinical indication and trial phase;

receiving, by the computing device, a selection of at least one individual task from said subset;

creating, by the computing device, a structured protocol modeling database for instantiating at least one object of said clinical trial protocol based on said selection of the at least one individual task;

receiving, by the computing device, at least one event for the clinical trial protocol; and

linking, by the computing device, said at least one individual task to said at least one event.

21. A method according to claim 20, further comprising:

generating, by the computing device, a table having said at least one event along a first dimension of said table and said at least one individual task along a second dimension of said table;

wherein linking comprises marking, by the computing device, with a user-perceptible distinguishing feature, at least one task-event linkage in said table at which said at least one individual task is assigned to said at least one event.

22. A method according to claim 21, further comprising providing, by the computing device, in dependence upon said at least one task-event linkage of said at least one individual task and said at least one event made, a total per-patient cost estimate for a member of the group consisting of:

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

(2) an event from said at least one event.

23. A method according to claim 21, further comprising auto-generating, by the computing device, in a clinical trial protocol document, a schedule of activities table in dependence upon said at least one task-event-linkage.

24. A method according to claim 20, further comprising in said structured protocol modeling database, the computing device instantiating at least one task object corresponding to said at least one individual task.

25. A method according to claim 24, further comprising:

instantiating, by the computing device, at least one event object in said protocol modeling database corresponding said at least one event; and

linking, by the computing device, user-selected ones of said at least one task object to user-selected ones of said at least one event object.

26. A system to develop a clinical trial protocol, the system comprising:

a memory device comprising a historical database, the historical database storing a plurality of individual tasks from multiple clinical trial protocols associated with past protocol dates, each individual task of said plurality of individual tasks being categorized for a particular clinical indication and particular trial phase; and

a protocol design tool operatively connected to said historical database, said protocol design tool configured to;

receive a request to query said historical database, said request including user-specified filtering criteria having a clinical indication, trial phase and past time window;

retrieve a subset of individual tasks from said plurality of individual tasks based on said filtering criteria, at least a first individual task in said subset from a first clinical trial protocol and a second individual task in said subset from a second clinical trial protocol, said past protocol dates of said first clinical trial protocol and said second clinical trial protocol being within said past time window, each of the individual tasks included in said subset being associated with a numerical association strength criterion that indicates at least a predetermined strength of association of each of the individual tasks in said subset to other clinical trial protocols for the clinical indication and trial phase;

receive a selection of at least one individual task from said subset; and

instantiate, in a structured protocol modeling database, at least one object identifying said at least one individual task.

27. A system according to claim 26, wherein the protocol design tool is further configured to exclude from said subset individual tasks whose association with the previous clinical trial protocols fail a particular association strength criterion.

28. A system according to claim 26, wherein the protocol design tool is further configured to instantiate at least one task object corresponding to said at least one individual task in the structured protocol modeling database of the clinical trial protocol.

29. A system according to claim 28, wherein the protocol design tool is further configured to:

instantiate at least one event object in the protocol modeling database; and

link the at least one task object to the at least one event object.

30. A system according to claim 26, wherein the protocol design tool is further configured to:

schedule said at least one individual task for performance in at least one event of the clinical trial protocol; and

insert into the protocol modeling database a purpose for performing said at least one individual task in the at least one event.

31. A system according to claim 30, wherein the protocol design tool is further configured to enter into the structured protocol modeling database, in response to user input, an outcome for association with said purpose.

32. A system according to claim 31, wherein the protocol design tool is configured to instantiate an outcome object for the outcome, and to link the outcome object with a task-event object that links said at least one individual task with said at least one event.

33. A system according to claim 26, wherein the protocol design tool is configured to retrieve said subset together with a cost estimate for at least one of the individual tasks in said subset, derived in dependence upon said historical database, each individual task of the plurality of individual tasks in said historical database including task costs.

34. A system according to claim 26, wherein the protocol design tool is further configured to:

receive at least one event for the clinical trial protocol; and

link said at least one individual task to said at least one event.

35. A system according to claim 34, wherein the protocol design tool is further configured to auto-generate, in a clinical trial protocol document, a schedule of activities table in dependence upon link of said at least one individual task to said at least one event.

36. A system according to claim 34, wherein the protocol design tool is further configured to retrieve, in dependence upon the link of said at least one individual task to said at least one event, a total per-patient cost estimate for a member of the group consisting of:

(1) a trial conducted according to the clinical trial protocol; and

(2) an event from said at least one event.

37. A system to develop a clinical trial protocol, the system comprising:

a memory device comprising a historical database, the historical database storing a plurality of individual tasks from multiple clinical trial protocols associated with past protocol dates, each individual task of said plurality of individual tasks being categorized for a particular clinical indication and particular trial phase; and

a protocol design tool operatively coupled to said historical database, said protocol design tool configured to;

receive a request to query said historical database, said request including user-specified filtering criteria having a clinical indication, trial phase and past time window;

retrieve a subset of individual tasks from said plurality of individual tasks based on said filtering criteria, at least a first individual task of said subset from a first clinical trial protocol and a second individual task of said subset from a second clinical trial protocol, said past protocol dates of said first clinical trial protocol and said second clinical trial protocol being within said past time window, each of the individual tasks included in said subset being associated with a numerical association strength criterion that indicates at least a predetermined strength of association of each of the individual tasks in said subset to other clinical trial protocols for the clinical indication and trial phase;

receive at least one event for the clinical trial protocol;

receive a selection of at least one individual task from said subset; and

link said at least one individual task to said at least one event.