Method and apparatus for clinical trials

• US 6,687,190 B2
• Filed: 12/21/2001
• Issued: 02/03/2004
• Est. Priority Date: 07/23/1999
• Status: Expired due to Term

• Current Assignee: Michael E. Infuso, Robert Momich
• Original Assignee: Michael E. Infuso, Robert Momich
• Inventors: Momich, Robert, Infuso, Michael E.
• Primary Examiner(s): MISKA, VIT W
• Application Number:
  US10/024,477
• Publication Number:
  US 20020064095A1
• Time in Patent Office: 774 Days
• Field of Search: 368/10, 368/73, 368/250, 221/1, 221/2, 221/3, 221/15, 600/300
• US Class Current: 368/10
• CPC Class Codes: A61J 2200/30 Compliance analysis for taking medication
• CPC Class Codes: A61J 2205/30 Printed labels
• CPC Class Codes: A61J 2205/60 using magnetic or electronic identifications, e.g. chips, RFID, electronic tags
• CPC Class Codes: A61J 2205/70 Audible labels, e.g. for pre-recorded info or messages
• CPC Class Codes: A61J 7/0418 with electronic history memory
• CPC Class Codes: A61J 7/0427 with direct interaction with a dispensing or delivery system
• CPC Class Codes: A61J 7/0481 working on a schedule basis
• CPC Class Codes: G06Q 10/109 Time management, e.g. calendars, reminders, meetings or time accounting
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients

Abstract

A method for conducting clinical trials for a medication uses a unique identifier, a clock and an smart memory associated with the medication. Information regarding a method of calculating a next take time is received. It is determined if an identifier field on the smart memory is empty and, if empty, the unique identifier is written onto the smart memory. If not empty, it is determined if the identifier in the identifier field is not the unique identifier and if not then exiting. On the other hand, if the unique identifier is present in the identifier field, then calculating the next take time; storing a next take time; and prompting at the next take time. The time on the clock is stored as a take time. In addition, a subject diary form is displayed and subject information in regard to subject diary form is stored.

Claims

1. A method for use in association with clinical trials for a medication using a unique identifier, a clock and a smart memory associated with the medication comprising the steps of:

determining if an identifier field on the smart memory associated with the medication is empty and, a) if empty, proceeding with a setup routine, b) if not empty, i) determining if the identifier in the identifier field is not the unique identifier then exiting;

or ii) if the unique identifier is present in the identifier field;

receiving information regarding a method of calculating a next take time;

calculating the next take time;

storing a next take time;

prompting at the next take time;

storing the time on the clock as a take time;

displaying a subject diary form; and

storing subject information in regard to the subject diary form.

2. A method as claimed in claim 1 wherein the subject diary forms are displayed at a time proximate to a time at which the next take time is prompted.

3. A method as claimed in claim 1 wherein the subject diary forms are displayed at predetermined times.

4. A method as claimed in claim 1 further including the step of receiving an indicator regarding taking the medication prior to the step of storing the time on the clock as a take time.

5. A method as claimed in claim 1 further including the steps of calculating a next take window and identifying if the present time is within the next take window.

6. A method as claimed in claim 1 further including the steps of calculating a deferred next take time and prompting at the deferred next take time.

7. A method as claimed in claim 1 further including the step of reading and displaying further information stored on the smart memory associated with the promoting device.

8. A method as claimed in claim 1 wherein the method is incorporated in one of an electronic personal organizer, a cell phone, a personal digital assistant and a hand held computer.

9. A method as claimed in claim 1 further including the following steps;

determining if the next form field is null;

if yes then determining if the next take field it null;

if yes then exiting;

if the next form field is not null then determining if the next form field date and time correspond to the clock date and time;

if yes then displaying the patient diary form;

if no then return to beginning; and

if the next take field is not null then determining if the next take field date and time correspond to the clock date and time;

if yes then prompting;

if no then return to beginning.

10. A method as claimed in claim 1 wherein the take time and the patient information is stored on one of the smart memory associated with the medication and a smart card.

11. A method as claimed in claim 1 wherein the take time and the patient information is stored on both the smart memory associated with the medication and a smart card.

12. A method as claimed in claim 1 further including the step of loading the subject diary form from one of a subject smart card, the smart memory associated with the medication, a remote site via a pointer on a subject smart card and a remote site via a pointer on the smart memory associated with the medication.

13. A method as claimed in claim 2 wherein the subject diary forms are additionally displayed at predetermined times.

14. A method as claimed in claim 13 further including the step of receiving an indicator regarding taking the medication prior to the step of storing the time on the clock as a take time.

15. A method as claimed in claim 14 further including the following steps;

determining if the next form field is null;

if yes then determining if the next take field it null;

if yes then exiting;

if the next form field is not null then determining if the next form field date and time correspond to the clock date and time;

if yes then displaying the patient diary form;

if no then return to beginning; and

if the next take field is not null then determining if the next take field date and time correspond to the clock date and time;

if yes then prompting;

if no then return to beginning.

16. A method as claimed in claim 15 further including the steps of calculating a next take window and identifying if the present time is within the next take window.

17. A method as claimed in claim 16 further including the steps of calculating a deferred next take time and prompting at the deferred next take time.

18. A method as claimed in claim 17 further including the step of reading and displaying further information stored on the smart memory on the prompting device.

19. A method as claimed in claim 18 wherein the take time and the patient information is stored on one of the smart memory associated with the medication and a smart card.

20. A method as claimed in claim 19 wherein the take time and the patient information is stored on both the smart memory associated with the medication and a smart card.

21. A method as claimed in claim 20 further including the step of loading the subject diary form from one of a subject smart card, the smart memory associated with the medication, a remote site via a pointer on a subject smart card and a remote site via a pointer on the smart memory associated with the medication.

22. A method as claimed in claim 1 wherein the setup routine includes the steps of:

writing the unique identifier onto the smart memory;

determining if taking now, if no then exiting, if yes then;

receiving information regarding a method of calculating a next take time;

calculating the next take time;

storing a next take time;

prompting at the next take time;

storing the time on the clock as a take time;

displaying a subject diary form; and

storing subject information in regard to the subject diary form.

23. A method as claimed in claim 1 wherein the subject diary forms are displayed responsive to a request.