Method and system for interactive prescription and distribution of prescriptions in conducting clinical studies

• US 5,991,731 A
• Filed: 02/01/1999
• Issued: 11/23/1999
• Est. Priority Date: 03/03/1997
• Status: Expired due to Term

• Current Assignee: University of Florida Research Foundation, Incorporated (State University System of Florida)
• Original Assignee: University of Florida (State University System of Florida)
• Inventors: Marks, Ronald G., Padgett, Phillip, Pepine, Carl J., Cooper-DeHoff, Rhonda M., Handberg-Thurmond, Eileen M., Colon, Michael
• Primary Examiner(s): MacDonald, Allen R.
• Assistant Examiner(s): PATEL, JAGDISH
• Application Number:
  US09/241,140
• Time in Patent Office: 295 Days
• Field of Search: 705/2, 705/3, 705/10, 705/14
• 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 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 70/40 relating to drugs, e.g. their side effects or intended usage

Abstract

A computer system (11, 12, 13) and method for managing data used in conducting clinical studies concerning subjects at a plurality of participating, geographically distributed clinical sites, each participating clinical site having a computer (17, 18, 19) for inputting, transmitting and receiving data over the Internet (15). An Internet network server computer (13) is interfaced to a database host computer (11) through a private network (12). The system (11, 12, 17, 18, 19) communicates data over the Internet (15, 16) to determine patient eligibility, randomization and initial prescriptions, which can then be adjusted by the physician online. The final prescription is printed out for signature and sent electronically to a distribution center (55). Study data is maintained in a database in the host computer (11) behind a firewall provided in the Internet server computer (13).

Claims

1. A computer system for conducting a clinical study concerning subjects at a plurality of participating sites, each participating site having a computer for inputting, transmitting and receiving data over the Internet, said participating sites being remote from a study management site for managing the clinical study, the computer system comprising:

a host computer including means for receiving identification, demographic and medical data about the subjects from the participating sites;

an Internet network server computer including means connected for receiving said identification, demographic and medical data about the subjects from the participating sites over the Internet and means connected for transferring said identification, demographic and medical data about the subjects to said host computer, said Internet network server computer thereafter executing a randomization routine by which the subjects are randomized to respective treatment strategies and responding to such randomization by transmission of a proposed prescription to one of the computers at the participating sites; and

a participating site communication program for running on computers at the participating sites for inputting, encrypting and transmitting identification, demographic and medical data about the subjects to the study management computer and for receiving from the Internet server computer, and displaying, data comprising said proposed prescription.

2. The computer system of claim 1, wherein the participating site communication means further comprises means for confirming or adjusting the prescription being displayed and means for communicating a confirmed or adjusted prescription to the Internet server computer.

3. The computer system of claim 1, wherein said host computer includes means for receiving said demographic and medical data and means responsive thereto to determine either non-eligibility or eligibility for participation of a subject in the clinical study.

4. The computer system of claim 1, wherein said participating site communication means includes means for transmitting said prescription confirmed or adjusted by the physician to the Internet server computer for transfer to the host computer, and wherein the Internet server computer includes means for transmission of said prescription to a distribution center.

5. The computer system of claim 1, wherein said participating site communication means includes means for printing out a prescription selected by a physician in response to said proposed prescription.

6. The computer system of claim 1, wherein the host computer including means for receiving identification, demographic and medical data about the subjects from the participating sites further includes a relational database.

7. The computer system of claim 6, wherein the relational database includes separate respective tables for users, clinical sites, permissions, eligibility data, randomization data, data on follow-up visits, endpoint status data and significant events data.

8. The computer system of claim 1, wherein the routine for randomization of the subjects to respective treatment strategies includes a randomization module for randomization of the subjects to respective treatment strategies in response to demographic and medical data.

9. The computer system of claim 1, wherein the host computer including means for receiving identification, demographic and medical data about the subjects from the participating sites further includes a relational database with tables and wherein the Internet network server executes a script for transferring data between data communication files transferred on the Internet and the tables of said relational database.

10. A method for managing a clinical study of a treatment strategy to be prescribed for subjects distributed at a plurality of participating sites which are geographically distributed in relation to a study management site, said method comprising:

inputting identification, demographic and medical data at said participating sites for respective subjects and transmitting said identification, demographic and medical data over the Internet to said study management site;

receiving said identification, demographic and medical data at an Internet server computer at the study management site;

transferring said identification, demographic and medical data from said Internet server computer to a host computer;

executing a randomization routine in the Internet server computer with respect to a subject for which identification, demographic and medical data has been received to assign the subject to a respective treatment strategy, and according to said treatment strategy transmitting a proposed prescription to a respective participating site; and

receiving and displaying said proposed prescription on a computer at said respective clinical site.

11. The method of claim 10, further comprising the step of adjusting or confirming said proposed prescription under direction of a physician while said proposed prescription is being displayed on the computer at said respective clinical site.

12. The method of claim 11, further comprising the steps of:

transmitting said proposed prescription as determined by said physician from said computer at said respective clinical site over said Internet to said Internet server computer, and eventually to said host computer; and

transmitting said physician-determined prescription from said Internet network server computer to a distribution center for filling said drug prescription for the subject.

13. The method of claim 11, further comprising the step of printing out a copy of the prescription for signature by a physician.

14. The method of claim 11, further comprising the step of:

transmitting said proposed prescription as determined by said physician from said computer at said respective clinical site over said Internet to said Internet server computer, and eventually to said host computer; and

wherein in said transfer of identification, demographic and medical data to a host computer further comprises inputting said identification, demographic and medical data into a relational database stored in said host computer; and

wherein said database is updated with said proposed prescription as determined by said physician.

15. The method of claim 10, wherein said step of transmitting a proposed prescription to a respective participating site provides limits to modifying said prescription according to a range of prescriptions determined for the clinical study.

16. The method of claim 10, further comprising:

inputting follow-up data at said clinical sites for respective subjects and transmitting said follow-up data over the Internet to said study management site;

receiving said follow-up data at an Internet server computer at the study management site;

transferring said follow-up data to a host computer;

executing a control routine in the host computer with respect to a subject for which follow-up data has been received to assign the subject to a stepped or non-stepped treatment strategy, and according to said treatment strategy transmitting a proposed prescription to a respective clinical site; and

receiving and displaying said proposed prescription on a computer at said respective clinical site.

17. A method for interactive prescription by a plurality of clinical study investigators at a plurality of geographically distributed sites, said method comprising:

inputting data at one of said distributed sites for a respective subject and transmitting said data over the Internet to a computing center;

receiving said data at said computing center;

executing a routine in a computer at the computing center with respect to said dat a received from said one of the distributed sites to determine a responsive form to be sent to said one of the distributed sites in which further data to be input to the computing center is limited by a parameter determined by said computer in said computing center; and

receiving and displaying said f orm at said one of the distributed sites;

inputting further data comprising a prescription into said form at said one of the distributed sites and transmitting said prescription to the computing center; and

transmitting said prescription from said computing center to a distribution facility for distributing a prescribed item to a subject in response to the prescription received from said one of the distributed sites.

18. The method of claim 17, wherein the computing center further comprises an Internet server computer and a database host computer having a database therein.

19. The method of claim 18, wherein the database is behind a firewall provided by the Internet server computer, so that the database is inaccessible to computers at the distributed sites.

20. The method of claim 19, further comprising the step of executing a script in the Internet server computer to transfer data between the Internet server computer and the database.