NETWORKED SYSTEM FOR INTERACTIVE COMMUNICATION AND REMOTE MONITORING OF PHARMACEUTICAL MANUFACTURER AND CLINICAL TRIALS

• US 20070168242A1
• Filed: 12/20/2006
• Published: 07/19/2007
• Est. Priority Date: 03/28/1997
• Status: Active Grant

• Current Assignee: Robert Bosch Healthcare Systems, Inc. (Robert Bosch GmbH)
• Original Assignee: Robert Bosch Healthcare Systems, Inc. (Robert Bosch GmbH)
• Inventors: Brown, Stephen
• Granted Patent: US 8,870,762 B2
• Time in Patent Office: Days
• US Class Current: 705/7
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: G06Q 30/02 Marketing; Price estimation or determination; Fundraising
• CPC Class Codes: G06Q 30/0601 Electronic shopping [e-shopping]
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: H04N 21/24 Monitoring of processes or resources, e.g. monitoring of server load, available bandwidth, upstream requests monitoring of server performance or load G06F11/34; arrangements for observation, testing or troubleshooting for broadcast or for distribution combined with broadcast H04H20/12
• CPC Class Codes: Y10S 128/905 Feedback to patient of biological signal other than brain electric signal
• CPC Class Codes: Y10S 128/92 Computer assisted medical diagnostics

Abstract

A system for remotely monitoring an individual. The system includes a server system for generating a script program from a set of queries. The script program is executable by a remote apparatus that displays information and/or a set of queries to the individual through a user interface. Responses to the queries that are entered through the user interface together with individual identification information are sent from the remote apparatus to the server system across a communication network. The server system also includes an automated answering service for providing a series of questions from a stored set of questions for an individual at the remote apparatus to respond to, storing responses to each provided question in the series of questions and providing a service based on the individual'"'"'s response to the questions.

Claims

1. A method of monitoring a clinical trial, comprising:

A) selecting a program from a number of programs stored on a server;

B) transmitting the program to a remotely situated apparatus through at least one communication network, wherein the program causes the apparatus to present one or more queries and one or more response choices to an individual and collect responses from the individual;

C) receiving the responses through the at least one communication network and storing the responses in the server; and

D) generating a report about a clinical trial based upon the responses.

2. The method according to claim 1, wherein said report is related to clinical development of one or more drugs.

3. The method according to claim 1, wherein said report is related to post marketing surveillance of one or more drugs.

4. The method according to claim 1, wherein said clinical trial comprises collecting data on an efficacy of one or more drugs.

5. The method according to claim 1, wherein said clinical trial comprises collecting data on one or more side effects of one or more drugs.

6. The method according to claim 1, wherein said clinical trial comprises collecting data on a quality of life impact of one or more drugs.

7. The method according to claim 1, wherein said clinical trial comprises monitoring use of one or more drugs.

8. The method according to claim 1, wherein said clinical trial comprises monitoring effects of one or more drugs.

9. The method according to claim 1, further comprising the step of measuring a physiological condition of the individual.

10. The method according to claim 9, wherein said physiological condition comprises a blood oxygen level.

11. The method according to claim 9, wherein said physiological condition comprises a blood glucose level.

12. The method according to claim 9, wherein said physiological condition comprises a blood pressure.

13. The method according to claim 9, wherein said physiological condition comprises a respiratory flow rate.

14. The method according to claim 1, wherein said individual is managing a chronic disease or condition.

15. The method according to claim 14, wherein said chronic disease comprises chronic obstructive pulmonary disease (COPD).

16. The method according to claim 1, further comprising the steps of:

entering queries and corresponding response choices regarding one or more clinical trials into the server;

generating one or more programs in the server using the queries and the response choices; and

storing the one or more programs on the server.

17. A system for remotely monitoring a pharmaceutical trial, comprising:

a server configured to communicate with at least one remotely situated apparatus through at least one communication network;

a user interface configured to communicate with the server and adapted for (i) entering, authoring, selecting, or any combination thereof, a set of queries to be answered by an individual and (ii) entering, authoring, selecting, or any combination thereof, corresponding response choices for each of the queries;

a program generator configured to generate a program to be executed by the remotely situated apparatus, wherein the program causes the apparatus to present the queries and the response choices to the individual and collect responses from the individual; and

one or more databases accessible by the server for storing the program, the responses received from the remotely situated apparatus and a list of pharmaceutical trial criteria to be assessed based upon the responses received.

18. The system according to claim 17, further comprising a monitoring device remotely situated from the server, the monitoring device configured to measure a physiological condition of the individual.

19. The system according to claim 18, wherein said physiological condition comprises one or more of a blood oxygen level, a blood glucose level, a blood pressure and a respiratory flow rate.

20. The system according to claim 17, wherein said list of pharmaceutical trial criteria to be assessed based upon the responses received comprises one or more of efficacy, side effects, quality of life impact, usage and drug effects.