System and method for matching patients with clinical trials

• US 7,711,580 B1
• Filed: 10/31/2000
• Issued: 05/04/2010
• Est. Priority Date: 10/31/2000
• Status: Expired due to Fees

• Current Assignee: Emergingmed.com
• Original Assignee: Emergingmed.com
• Inventors: Hudson, Courtney
• Primary Examiner(s): Gilligan; C. Luke
• Assistant Examiner(s): Porter; Rachel L
• Application Number:
  US09/699,372
• Time in Patent Office: 3,472 Days
• Field of Search: 705 2- 3, 600/300
• US Class Current: 705/3
• 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 40/20 for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders
• CPC Class Codes: G16H 70/00 ICT specially adapted for the handling or processing of medical references

Abstract

A system and method for matching patients with clinical trials and particular trial sites, prequalifying patients for clinical trials and trial sites, and providing information to patients to allow them to inform themselves about available clinical trials and trial sites. The method comprises receiving patient profile information for a patient at a server connected to a computer network, the patient profile information submitted by a user at a terminal connected to the network, comparing the patient profile information with acceptance criteria for clinical trials stored in a database, the comparison performed by the server, determining whether the patient prequalifies for any of the clinical trials, and notifying the user and the trial site whether the patient has prequalified for any clinical trials.

Claims

1. A method for matching patients with clinical trials, comprising:

receiving acceptance criteria for clinical trials and a series of questions targeted to at least one specific clinical trial at a server, wherein the acceptance criteria for clinical trials and the series of questions targeted to at least one specific clinical trial are provided over the Internet by a system of a clinical trial sponsor or investigator;

receiving patient profile information for a patient at the server, the patient profile information submitted over the Internet by a user at a user terminal;

comparing the patient profile information with the acceptance criteria for clinical trials stored in a database, the comparison performed by the server; and

automatically, determining that the patient prequalifies for any of the clinical trials based on the comparison of the patient profile information with the acceptance criteria;

notifying the user that the patient has prequalified for at least one specific clinical trial when the patient prequalifies for any of the clinical trials;

presenting to the user the series of questions targeted to the at least one specific clinical trial after determining that the patient prequalifies for any of the clinical trials, wherein the series of questions are provided by the server to the user terminal over the Internet;

determining that the patient prequalifies for the at least one specific clinical trial based on responses to the targeted questions;

storing the responses to the targeted questions;

providing the user with an application for the user to request that the patient be a participant in the specific clinical trial at a clinical trial site for the specific clinical trial when the patient prequalifies for the at least one specific clinical trial, wherein the application is provided by the server to the user terminal over the Internet; and

providing the contact information for the clinical trial site when the completed application is accepted.

2. The method of claim 1, further including providing the user with instructions for enrolling the patient in the specific clinical trial.

3. The method of claim 1, wherein receiving patient profile information further includes asking the user a plurality of questions;

and creating a patient profile based on the responses to the plurality of questions.

4. The method of claim 3, wherein the step of asking the user a plurality of questions includes:

asking one or more static questions;

asking one or more dynamic questions which are selected based on responses to other static and dynamic questions; and

creating the patient profile based on the responses to the static and dynamic questions.

5. The method of claim 4, wherein static questions, dynamic questions, and targeted questions are provided with a plurality of answer options, and the user may select one or more answer options in order to answer the questions.

6. The method of claim 5, wherein an answer is submitted in a specified format, the specified format being suitable for evaluation by a computer program process.

7. The method of claim 6, further including:

updating the static questions, dynamic questions, or answer options.

8. The method of claim 1, wherein the completed application is submitted to the server.

9. The method of claim 8, wherein the completed application is forwarded to the clinical trial site.

10. The method of claim 9, wherein the patient profile is forwarded to the clinical trial site with the completed application.

11. The method of claim 10, wherein the completed application and patient profile forwarded to the clinical trial site includes a patient ID number, but does not include the patient'"'"'s name to protect the privacy of the patient.

12. The method of claim 11, further including:

notifying the clinical trial sponsor when the completed application is submitted to the clinical trial site.

13. The method of claim 1, wherein a search engine is provided that allows a search for medical information before selecting a clinical trial.

14. The method of claim 1, wherein the acceptance criteria includes geographic location.

15. A system for matching patients with clinical trials, comprising:

a server connected to the Internet;

a data storage device included in the server;

a database located in the data storage device, the database storing patient profile information for a patient and acceptance criteria for a plurality of clinical trials

a system of a clinical trial sponsor or investigator for providing the acceptance criteria for clinical trials and a series of questions targeted to at least one specific clinical trial to the server over the Internet; and

a user terminal for providing the patient profile information for the patient to the server over the Internet;

the server comparing the patient profile information with the acceptance criteria for the clinical trials stored in the database;

automatically, determining that the patient prequalifies for any of the clinical trials based on the comparison of the patient profile information with the acceptance criteria;

notifying the user that the patient has prequalified for at least one specific clinical trial when the patient prequalifies for any of the clinical trial;

presenting to the user the series of questions targeted to the at least one specific clinical trial after determining that the patient prequalifies for any of the clinical trials, wherein the series of questions are provided by the server to the user terminal over the Internet;

determining that the patient prequalifies for the at least one specific clinical trial based on responses to the targeted questions, storing the responses to the targeted questions;

providing the user with an application for the user to request that the patient be a participant in the specific clinical trial at a clinical trial site for the specific clinical trial when the user prequalifies for the at least one specific clinical trial, wherein the application is provided by the server to the user terminal over the Internet, and providing the contact information for the clinical trial site when the completed application is accepted.

16. The system of claim 15, wherein the database contains at least one of;

a) diseasehub-disease records;

b) drug records;

c) content records;

d) clinical trial records;

e) question records;

f) device records;

g) patient profile records;

g) user registration records; and

g) trial site records.

17. The system of claim 16, wherein a record in the database contains links to other related records.

18. The system of claim 16, wherein the server transmits a plurality of questions over the Internet, the server also transmits a plurality of answer choices for each question, the server receives responses, and the server builds a patient profile based on the responses.

19. The system of claim 15, wherein the server retrieves a disease/sub-disease record corresponding to a received disease/sub-disease, the disease/-sub-disease record containing links to question records, the server retrieving the question records to access questions.

20. The system of claim 15, wherein the completed application is submitted to the server.

21. The system of claim 20, further comprising the server forwarding to the completed application to the clinical trial site.

22. The system of claim 21, further comprising the server forwarding the registration information to the clinical trial site with the completed application.

23. The system of claim 22, wherein the completed application and registration information forwarded to the clinical trial site includes a patient ID number, but does not include the patient'"'"'s name to protect the privacy of the patient.

24. The system of claim 23, further including:

the server notifying the clinical study sponsor when the completed application is submitted to the clinical trial site.

25. The system of claim 15 further comprising,

providing a search engine that allows a search for medical information before selecting a clinical study.

26. Computer executable software code stored on a computer readable medium, performing a method for matching patients with clinical trials, comprising:

receiving acceptance criteria for clinical trials and a series of questions targeted to at least one specific clinical trial at a server, wherein the acceptance criteria for clinical trials and the series of questions targeted to at least one specific clinical trial are provided over the Internet by a system of a clinical trial sponsor or investigator;

receiving patient profile information for a patient at the server, the patient profile information submitted over the Internet by a user at a user terminal;

comparing the patient profile information with the acceptance criteria for clinical trials stored in a database, the comparison performed by the server; and

automatically, determining that the patient prequalifies for any of the clinical trials based on the comparison of the patient profile information with the acceptance criteria;

notifying the user that the patient has prequalified for at least one specific clinical trial when the patient prequalifies for any of the clinical trials;

presenting to the user the series of questions targeted to the at least one specific clinical trial after determining that the patient prequalifies for any of the clinical trials, wherein the series of questions are provided by the server to the user terminal over the Internet;

determining that the patient prequalifies for the at least one specific clinical trial based on responses to the targeted questions;

storing the responses to the targeted questions;

providing the user with an application for the user to request that the patient be a participant in the specific clinical trial at a clinical trial site for the specific clinical trial when the patient prequalifies for the at least one specific clinical trial, wherein the application is provided by the server to the user terminal over the Internet; and

providing the contact information for the clinical trial site when the completed application is accepted.

27. The computer executable software code of claim 26, wherein the completed application is submitted to the server.

28. The computer executable software code of claim 27, further comprising the forwarding to the completed application to the clinical trial site.

29. The computer executable software code of claim 28, further comprising the forwarding the registration information to the clinical trial site with the application.

30. The computer executable software code of claim 26, wherein the completed application and registration information forwarded to the clinical trial site includes a patient ID number, but does not include the patient'"'"'s name to protect the privacy of the patient.

31. The computer executable software code of claim 30, further including:

the server notifying the clinical study sponsor when the completed application is submitted to the clinical trial site.

32. The computer executable software code of claim 26, further comprising providing a search engine that allows a search for medical information before selecting a clinical study.