Clinical trial process improvement method and system

• US 20040078216A1
• Filed: 04/12/2002
• Published: 04/22/2004
• Est. Priority Date: 02/01/2002
• Status: Abandoned Application

• Current Assignee: Gregory Toto
• Original Assignee: Gregory Toto
• Inventors: Toto, Gregory
• Application Number:
  US10/121,967
• Publication Number:
  US 20040078216A1
• Time in Patent Office: Days
• US Class Current: 705/2
• 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 40/67 for remote operation

Abstract

A clinical trial method provides a repository which includes a plurality of clinical trial documents from one or a plurality of document sources. At least a portion of the clinical trial documents in the repository are compared with a plurality of clinical trial documents accessed from one or the plurality of document sources. A current copy of a clinical trial document is maintained in the repository. A query interface to the repository is provided for access to at least a portion of the clinical trial documents in the repository.

Claims

1. A clinical trial method, comprising:

providing a repository that includes a plurality of clinical trial documents from one or a plurality of document sources;

comparing at least a portion of the clinical trial documents in the repository with a plurality of clinical trial documents accessed from one or the plurality of document sources;

maintaining a current copy of a clinical trial document in the repository; and

providing a query interface to the repository for access to at least a portion of the clinical trial documents in the repository.

2. The method of claim 1, wherein the document source is selected from a direct clinical trial information database import, an incremental clinical trial information database import, a remote clinical trial information database query, a remote clinical trial information web-site query, and parsing of the content of a clinical trials web site.

3. The method of claim 2, wherein a clinical trials web-site is selected from HTML, XHTML, SGML, XML, WML, WAP, BREW, i-Mode, and plain text encoded clinical trials information accessible by a communication network.

4. The method of claim 3, wherein the communication network is selected from the internet, local area network, wide area network, broadband network, wireless network and telephone system.

5. The method of claim 1, further comprising:

accessing at least a portion of a clinical trial document from the one or the plurality of document sources.

6. The method of claim 1, further comprising:

creating a clinical trial document from different versions of a clinical trial document accessed from the one or the plurality of document sources.

7. The method of claim 6, further comprising:

updating a clinical trial document from different versions of a clinical trial document accessed from the one or the plurality of document sources.

8. The method of claim 1, further comprising:

accessing a document source in response to a ranking score of the one or the plurality of document sources.

9. The method of claim 8, further comprising:

generating a ranking score for each of the one or the plurality of document sources; and

updating a clinical trial document in the repository in response to a ranking score of the clinical trial document.

10. The method of claim 9, wherein the ranking score is determined by at least one of, a document source rating, an age of the repository'"'"'s clinical trial documents accessed from a document source, a historical frequency that at least a portion of a clinical trial document from a document source is included by the repository in response to a query.

11. The method of claim 9, wherein the document source rating is determined by at least one of, a document source'"'"'s content update frequency, an age of the document source'"'"'s content, a document source'"'"'s content breadth, and a content source'"'"'s content depth.

12. The method of claim 11, wherein the document source content breadth is determined by a reviewer or assigned by the repository.

13. The method of claim 12, further comprising:

accessing at least a portion of the clinical trial documents accessible from the at least one or the plurality of document sources;

providing a ranking score for the at least one or the plurality of document sources, wherein the ranking is based on a quantity of documents accessible from the at least one or the plurality of document sources; and

assigning a ranking to the at least one or the plurality of document sources.

14. The method of claim 11, wherein the document source content depth is subjectively assigned by a reviewer or assigned by the repository.

15. The method of claim 14, further comprising:

accessing at least a portion of clinical trial documents accessible from the at least one or the plurality of document sources;

providing a ranking score for the at least one or the plurality of document sources, wherein the ranking is based on a length of clinical trial documents accessed from the at least one or the plurality of document sources; and

assigning a ranking to the at least one or the plurality of document sources.

16. The method of claim 1, wherein meta-information associated with a clinical trial document in the repository is maintained in the repository.

17. The method of claim 16, wherein meta-information includes at least one of, a date and time the clinical trial document was added to the repository, a date and time a clinical trial document was accessed from a document source, at least one document source of the clinical trial document, a portion of the clinical trial document accessed from the document source, and the date and time the clinical trial document in the repository was updated from the document source.

18. The method of claim 1, wherein a clinical trial document in the repository is compared with the clinical trial document from at the at least one or the plurality of document sources.

19. The method of claim 18, further comprising:

comparing a clinical trial document in the repository with a clinical trial document from at least one or the plurality of document sources;

determining a clinical trial document from the at least one or the plurality of document sources not included in the repository; and

adding to the repository the clinical trial document not included in the repository.

20. The method of claim 19, wherein each step of claim 19 is repeated for all clinical trial documents in the repository.

21. The method of claim 18, further comprising:

updating at least a portion of the clinical trial documents in the repository of content with content from a newer clinical trial document.

22. The method of claim 21, further comprising:

providing notice to a system administrator of the updating of at least a portion of the clinical trial documents in the repository.

23. The method of claim 21, further comprising:

receiving confirmation from a system administrator to accept a clinical trial document from the at least one or the plurality of document sources.

24. The method of claim 21, further comprising:

repeating steps of claim 21 for all clinical trial documents in the repository.

25. The method of claim 18, further comprising:

determining when a clinical trial document in the repository is no longer accessible from the at least one or the plurality of document sources; and

removing clinical trial documents from the repository that are no longer accessible from the at least one or the plurality of document sources.

26. The method of claim 25, further comprising:

repeating the steps of claim 25 for all clinical trial documents in the repository.

27. The method of claim 25, further comprising:

determining a document source of the at least one or the plurality of document sources that contains an different version of a clinical trial document; and

updating at least part of a clinical trial document in the repository with content a corresponding part of a clinical trial document.

28. The method of claim 1 further comprising:

accessing a document source from the at least one or the plurality of document sources in response to a length of time elapsed since a clinical trial document was added or updated in the repository from the document source.

29. The method of claim 28, further comprising:

determining the length of time elapsed since a clinical trial document was added or updated in the repository;

determining if the length of time elapsed exceeds a threshold value; and

updating at least a portion of the clinical trial documents in the repository when the elapsed time threshold value is exceeded.

30. The method of claim 1, wherein clinical trial documents are organized in a structured relationship in the repository according to a document characteristic, a document classification, and a clinical trial detail.

31. The method of claim 30, wherein the document characteristic includes at least one of, a clinical trial document title, if the clinical trial document is new, date of clinical trial document updated, a date the clinical trial document was added in the system, a date the clinical trial document was updated in the clinical trial information system, clinical trial document language, medical or lay intended audience of a clinical trial document, if a pre-screen questionnaire is associated with a clinical trial document, and clinical trial document source.

32. The method of claim 30, wherein the document classification includes at least one of, International Classification of Disease number, Diagnostic and Statistical Manual of Mental Disorders classification, histopathological disease classification, and a disease condition.

33. The method of claim 30, wherein the clinical trial detail includes at least one a location of a clinical trial, a medical organizational affiliation of a clinical trial investigative site, a hospital affiliation of a clinical trial investigative site, a clinical trial enrollment contact information, a clinical trial investigator name, a clinical trial investigator specialty, a clinical trial protocol ID, a therapeutic drug, a gene expression and an insurance company covering clinical trial treatment.

34. The method of claim 31, wherein the clinical trial document'"'"'s lay or medical target audience is determined.

35. The method of claim 34, further comprising:

maintaining by the repository a database of medical terms;

generating a ranking score for a clinical trial documentation response to a frequency of occurrence of medical terms in a clinical trial document; and

categorizing a clinical trial document'"'"'s target audience as lay if the ranking is less than a threshold value and as medical if the ranking is equal or greater than a threshold value.

36. The method of claim 30, wherein the structured relationship between documents of a document source is converted by the repository to the structured relationship of the repository.

37. The method of claim 1, further comprising:

providing a query interface for searching the repository in response to at least one of, a keyword phrase, a document characteristic, a document classification, and a clinical trial detail.

38. The method of claim 37, wherein the document characteristic includes at least one of, a clinical trial document title, if the clinical trial document is new, date of clinical trial document updated, a date the clinical trial document was added in the system, a date the clinical trial document was updated in the clinical trial information system, clinical trial document language, medical or lay intended audience of a clinical trial document, if a pre-screen questionnaire is associated with a clinical trial document, and a clinical trial document source.

39. The method of claim 37, wherein the document classification includes at least one of, International Classification of Disease number, Diagnostic and Statistical Manual of Mental Disorders classification, histopathological disease classification, and a disease condition.

40. The method of claim 37, wherein the clinical trial detail includes at least one a location of a clinical trial, a medical organizational affiliation of a clinical trial investigative site, a hospital affiliation of a clinical trial investigative site, a clinical trial enrollment contact information, a clinical trial investigator name, a clinical trial investigator specialty, a clinical trial protocol ID, a therapeutic drug, a gene expression and an insurance company covering clinical trial treatment.

49. The system of claim 41, further comprising:

a at least one permissions server coupled to the document server.

51. The system of claim 41, wherein the at least one document server is configured to permit polling by a client.

41. A clinical trial information system, comprising:

at least one database including clinical trial information for a at least one clinical trial;

a user interface including a plurality of selectable user inputs to permit a user to access the at least one database;

at least one document server coupled to the at least one database and configured to provide information exchange between a user and at least one third-party user.

42. The system of claim 41, further comprising:

a client coupled to the database that provides a user with access to medical information in the at least one database.

43. The system of claim 42, wherein the client is selected from software residing in a desktop computer device, software residing in a portable computer device, a communication device, and software residing in a computer information system.

44. The system of claim 41, further comprising:

a network coupled to the at least one database, the network configured to provide communication between clients by peer to peer communication protocols.

45. The system of claim 44, wherein the network is selected from at least one of the internet, local area network, wide area network, broadband network, wireless network, wired network, virtual private network, and telephone system.

46. The system of claim 45, further comprising:

an encryption mechanism coupled to the network configured to provide encryption of communication between a client and the at least one database; and

an encryption mechanism coupled to the network configured to provide encryption of communication between a client and a document server.

47. The system of claim 46, wherein the encryption mechanism is selected from at least one of, PKI, TLS, WTLS, SSL, S/MIME, VPN, and IPSec.

48. The system of claim 41, further comprising:

a at least one authentication server coupled to the document server.

50. The system of claim 41, further comprising:

at least one routing server coupled to the document server.

52. The system of claim 41, wherein the at least one document server is configured to provide selected medical information to a user.

53. The system of claim 41, where in the at least one document server is configured to deliver the selected medical information to the user in response to criteria provided to the document server by a client.

54. The system of claim 41, wherein the at least one document server is configured to deliver the selected medical information to the user in response to the user'"'"'s identity provided to the document server by a client.

55. The system of claim 41, wherein the at least one document server is configured to authenticate transactions conducted between the document server and at least one of a client, routing server, audit server, and a permissions server.

56. The system of claim 41, wherein the at least one document server is configured to encrypt communication between the document server and at least one of a client, routing server, audit server, and a permissions server.

57. A clinical trial information system, comprising:

at least one database including clinical trial information for a at least one clinical trial;

a user interface including a plurality of selectable user inputs to permit a user to access the at least one database;

at least one routing server coupled to the database and configured to provide anonymous communication between a client and at least one third-party client.

58. The system of claim 57, further comprising:

a client coupled to the database that provides a user with access to medical information in the at least one database.

59. The system of claim 58, wherein the client is selected from software residing in a desktop computer device, software residing in a portable computer device, a communication device, and software residing in a computer information system.

60. The system of claim 57, further comprising:

a network coupled to the at least one database, the network configured to provide communication between clients by peer to peer communication protocols.

61. The system of claim 60, wherein the network is selected from at least one of the internet, local area network, wide area network, broadband network, wireless network, wired network, virtual private network, and telephone system.

62. The system of claim 61, further comprising:

an encryption mechanism coupled to the network configured to provide encryption of communication between a client and the at least one database; and

an encryption mechanism coupled to the network configured to provide encryption of communication between a client and a document server.

63. The system of claim 62, wherein the encryption mechanism is selected from at least one of, PKI, TLS, WTLS, SSL, S/MIME, VPN, and IPSec.

64. The system of claim 57, further comprising:

at least one authentication server coupled to the routing server.

65. The system of claim 57, further comprising:

at least one permissions server coupled to the routing server.

66. The system of claim 57, further comprising:

at least one routing server coupled to the document server.

67. The system of claim 57, wherein the at least one routing server is configured to provide anonymous message exchange between a user and at least one third-party user via a client.

68. The system of claim 67, wherein the at least one routing server is configured to replace a user'"'"'s identifiable information in a message with an anonymous identifier.

69. The system of claim 67, where in a user'"'"'s identifiable information and the anonymous identifier are coupled and retained within the routing server for a defined period of time.

70. The system of claim 67, wherein the anonymous identifier and coupled identifiable information are used by the routing server to direct a third-party user'"'"'s reply to an anonymous message to the user originating the message without revealing a user'"'"'s identifying information to the third-party user.

71. The system of claim 57, wherein the at least one document server is configured to authenticate transactions conducted between the document server and at least one of a client, routing server, audit server, and a permissions server.

72. The system of claim 57, wherein the at least one routing server is configured to encrypt communication between a client and at least one of a third-party client, document server, audit server, and a permissions server.