Method for identifying and communicating with potential clinical trial participants

• US 20040172293A1
• Filed: 11/19/2003
• Published: 09/02/2004
• Est. Priority Date: 01/21/2003
• Status: Abandoned Application

• Current Assignee: Siemens Medical Solutions USA Incorporated (Siemens AG)
• Original Assignee: Siemens Medical Solutions USA Incorporated (Siemens AG)
• Inventors: Bruschi, Paul, Sherman, William, Masticola, Stephen P.
• Application Number:
  US10/716,919
• Publication Number:
  US 20040172293A1
• Time in Patent Office: Days
• US Class Current: 705/2
• CPC Class Codes: G06F 21/6254 by anonymising data, e.g. decorrelating personal data from the owner's identification
• 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

The present invention is a method and system for selecting clinical trial candidates. Medical records are obtained from a source of patient clinical data, and are searched by a clinical trial candidate identification service for suitability for a particular clinical trial. The privacy of patients whose medical records are searched is preserved by replacing the identity of the patient with a secure patient code before the records are released to the clinical trial candidate identification service.

Claims

1. A method for identifying clinical trial candidates, the method comprising the steps of:

receiving from a patient clinical data source, patient data including identities of patients;

replacing the identities of the patients in the patient data with secure patient codes;

forwarding the patient data with secure patient codes to a clinical trial candidate identification service;

receiving from the clinical trial candidate identification service a clinical trial candidate proposal including a secure patient code corresponding to a proposed clinical trial candidate;

determining an identity of the proposed clinical trial candidate from the secure patient code; and

forwarding the identity of the proposed clinical trial candidate to a candidate contact.

2. The method of claim 1, wherein the candidate contact is a health care provider of the candidate.

3. The method of claim 1, wherein the candidate contact is the proposed clinical trial candidate.

4. The method of claim 1, wherein the step of replacing the identities of the patients in the patient data with secure patient codes comprises encrypting the identities to create secure patient codes, and the step of determining an identity of the proposed clinical trial candidate comprises decrypting the secure patient code corresponding to the proposed clinical trial candidate.

5. The method of claim 1, wherein the step of replacing the identities of the patients in the patient data with secure patient codes comprises replacing the identities with unique codes and maintaining a table correlating the identities with the unique codes, and the step of determining an identity of the proposed clinical trial candidate comprises looking up in the table an identity of a patient corresponding to the secure patient code.

6. The method of claim 1, further comprising the step of extracting patient medical information from the patient data received from a patient clinical data source.

7. The method of claim 1, further comprising the step of reformatting the patient data received from a patient clinical data source.

8. The method of claim 1, wherein the clinical data source is a database containing transactions between health care providers and payers.

9. The method of claim 1, wherein the clinical data source is a hospital network.

10. The method of claim 1, further comprising the steps of:

receiving from the candidate contact a status of the clinical trial candidate proposal; and

forwarding the status to the clinical trial candidate identification service.

11. The method of claim 10, wherein the status includes the identity of the proposed candidate, and the method further comprises the step of replacing the identity of the proposed candidate with a secure patient code before forwarding the status to the clinical trial candidate identification service.

12. The method of claim 1, further comprising the steps of:

receiving from the clinical trial candidate identification service, descriptive information about a clinical trial of the clinical trial candidate proposal; and

forwarding the information to the candidate contact.

13. A method for identifying clinical trial candidates, the method comprising the steps of:

receiving at least one clinical data record, each said record including clinical data and a secure patient code uniquely identifying the record without revealing an identity of a corresponding patient;

receiving a candidate selection criterion for a clinical trial;

searching the at least one clinical data record for a matching clinical data record based on the candidate selection criterion; and

if a matching clinical data record is found, then forwarding a contact request including at least a secure patient code from the matching clinical data record.

14. The method of claim 13, wherein the contact request is forwarded to a trusted entity having an identity of a patient corresponding to the forwarded secure patient code.

15. The method of claim 13, wherein the secure patient code is an encrypted identity of a patient.

16. The method of claim 13, wherein the secure patient code is a unique code corresponding to an entry in a table accessible to a trusted entity.

17. The method of claim 13, further comprising the step of receiving descriptive information about the clinical trial, and wherein the contact request includes the descriptive information.

18. The method of claim 13, wherein the at least one clinical data record is received from a data exchange service.

19. The method of claim 18, wherein the secure patient code corresponding to a matching clinical data record is forwarded to the data exchange service.

20. The method of claim 13, wherein the at least one clinical data record is received from an entity controlling a database containing transactions between health care providers and payers.

21. The method of claim 13, wherein the secure patient code corresponding to a matching clinical data record is forwarded to an entity controlling a database containing transactions between health care providers and payers.

22. The method of claim 13, further comprising the step of:

maintaining records of matching clinical data records; and

wherein the step of forwarding a contact request including a secure patient code is performed only if that code has not already been forwarded.

23. A method for selecting clinical trial candidates, the method comprising the steps of:

periodically receiving clinical data records, each said record including clinical data and a secure patient code uniquely identifying the record without revealing an identity of a corresponding patient;

periodically searching the data records to identify records of clinical trial candidates.

24. A system for identifying clinical trial candidates, comprising:

a data exchange service for receiving patient records from a patient clinical data source and replacing identities of patients in each patient record with a secure patient code;

a clinical trial candidate identification service for receiving the patient records with secure patient codes from the data exchange service, and identifying a patient record as a clinical trial candidate.

25. The system of claim 24, wherein the clinical trial candidate identification service forwards a secure patient code of the identified patient record to the data exchange service, and the data exchange service determines the identity of the patient for contacting the patient.

26. The system of claim 24, wherein the data exchange service receives a status of the clinical trial candidate proposal, replaces an identity of the proposed candidate with a secure patient code;

and forwards the status to the clinical trial candidate identification service.

27. The system of claim 24, wherein the clinical trial candidate identification service is further for receiving candidate selection criteria for a clinical trial, and the clinical trial candidate identification service identifies a patient record based on the candidate selection criteria.

28. The system of claim 24, wherein the data exchange service replaces the identities of the patients with secure patient codes that are encryptions of the identities of the patients.

29. The system of claim 24, wherein the data exchange service replaces the identities of the patients with secure patient codes that are unique codes, and the data exchange service further comprises a lookup table correlating each unique code with a patient code.

30. The system of claim 24, wherein the data exchange service is further for extracting patient medical information from the patient data received from a patient clinical data source.

31. The system of claim 24, wherein the data exchange service is further for reformatting the patient data received from a patient clinical data source.

32. The system of claim 24, wherein the clinical data source is a database containing transactions between health care providers and payers.

33. The system of claim 24, wherein the clinical data source is a hospital network.