Methods for determining parameters and planning clinical studies in automatic study and data management systems

• US 20080194920A1
• Filed: 05/31/2007
• Published: 08/14/2008
• Est. Priority Date: 02/09/2007
• Status: Active Grant

• Current Assignee: Siemens Healthcare GMBH (Siemens AG)
• Original Assignee: Siemens AG
• Inventors: Schmidt, Markus, Schneider, Siegfried, Zahlmann, Gudrun
• Granted Patent: US 8,529,446 B2
• Time in Patent Office: Days
• US Class Current: 600/300
• 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

Abstract

In a method for determining a parameter in an automatic study and data management system, data is gathered in a knowledge database, and a parameter is determined based the data gathered in the knowledge database. The data is correlated to at least one of a configuration and implementation of a previous clinical study. The parameter is usable for configuring a future clinical study.

Claims

1. A method for automatically determining a parameter in a system for configuring a clinical study, the method comprising:

gathering, in a knowledge database, data correlated to at least one of a configuration and implementation of a first clinical study; and

automatically determining the parameter using the knowledge database, the parameter being usable for configuring one of the first and at least one second clinical study.

2. The method of claim 1, wherein the parameter is indicative of at least one characteristic of a configuration of at least one of the first and the second clinical study.

3. The method of claim 1, wherein at least one of the first and the at least one second clinical study is an image-based study.

4. The method of claim 1, wherein the data is gathered by an automatic study and data management system.

5. The method of claim 4, wherein at least one of the first and the at least one second clinical study is an image-based study.

6. The method of claim 1, wherein the data gathered in the knowledge database includes at least one of image data, metadata and study results, the metadata being associated with the image data.

7. The method of claim 1, wherein the determined parameter is associated with at least one of a study protocol and a standard operating procedure for the at least one second clinical study.

8. The method of claim 1, wherein the parameter is determined iteratively during implementation of the at least one second clinical study.

9. The method of claim 1, further comprising:

implementing the at least one second clinical study using the determined parameter.

10. The method of claim 1, wherein the parameter is determined iteratively during the implementation of the at least one second clinical study.

11. The method of claim 1, further comprising:

designing the at least one second clinical study based at least in part on the parameter.

12. The method of claim 11, further comprising:

implementing the designed at least one second clinical study.

13. The method of claim 1, wherein the first clinical study is carried out prior to the at least one second clinical study.

14. The method of claim 1, wherein the first clinical study is a previous clinical study and the at least one second clinical study is a future clinical study.

15. A method for automatically planning a clinical study using an automatic data and study management system, the method comprising:

gathering, in a knowledge database, data correlated to at least one of a configuration and implementation of a previous clinical study;

determining a parameter using the knowledge database; and

configuring a clinical study based on the determined parameter.

16. The method of claim 15, wherein the clinical study is an image-based study.

17. The method of claim 15, wherein the gathered data includes at least one of image data, metadata and study results, the metadata being associated with the image data.

18. The method of claim 15, wherein the determined parameter is associated with at least one of a study protocol and a standard operating procedure for the clinical study.

19. The method of claim 15, further comprising:

implementing the configured clinical study.

20. A computer readable medium storing computer program instructions executable by a computer, the instructions, when executed by the computer, causing the computer to execute a method for automatically determining a parameter in a system for configuring a clinical study, the method comprising:

gathering, in a knowledge database, data correlated to at least one of a configuration and implementation of a first clinical study; and

automatically determining the parameter using the knowledge database, the parameter being usable for configuring one of the first and at least one second clinical study.

21. The computer readable medium of claim 20, wherein the method further comprises:

designing the at least one second clinical study based at least in part on the parameter.

22. The computer readable medium of claim 20, wherein the method further comprises:

implementing the designed at least one second clinical study.

23. The computer readable medium of claim 20, wherein the first clinical study is carried out prior to the at least one second clinical study.

24. The computer readable medium of claim 20, wherein the first clinical study is a previous clinical study and the at least one second clinical study is a future clinical study.

25. A computer readable medium storing computer program instructions executable by a computer, the instructions, when executed by the computer, causing the computer to execute a method for automatically planning a clinical study using an automatic data and study management system, the method comprising:

gathering, in a knowledge database, data correlated to at least one of a configuration and implementation of a first clinical study;

determining a parameter using the knowledge database; and

configuring at least one of the first and at least one second clinical study based on the determined parameter.

26. A data and study management system comprising:

a first management system configured to gather and store data correlated to at least one of a configuration and an implementation of a first clinical study, the first management system being further configured to determine a parameter based on the gathered and stored data, the parameter being usable in configuring at least one of the first and at least one second clinical study, the first management system including a knowledge database for storing the data.

27. The data and study management system of claim 26, further comprising:

a second management system configured to determine procedures for a future clinical study based on the determined parameter.