Integrated data collection and analysis for clinical study

• US 20060224326A1
• Filed: 03/31/2005
• Published: 10/05/2006
• Est. Priority Date: 03/31/2005
• Status: Abandoned Application

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Ujhelyi, Michael R., Carney, James K., Donders, Adrianus P., Audet, Sarah A., St. Ores, John W., Gottesman, Janell M.
• Application Number:
  US11/096,434
• Publication Number:
  US 20060224326A1
• Time in Patent Office: Days
• US Class Current: 702/19
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A data collection system includes remote, implantable sensors for monitoring one or more patient parameters, collecting and processing data from those sensors and utilizing that data in the performance of a clinical study of a drug or other pharmacological agent. The system assists with preparation of a protocol for a clinical trial; presentation of that protocol; assuring compliance with the protocol; and generating useful results from data collected via the system and externally for presentation to an approval forum.

Claims

1. A method of conducting a clinical trial for a drug comprising:

generating a protocol for conducting the clinical trial for the drug and providing the protocol to a host data collection system;

implanting an implantable sensor into a plurality of patients enrolled in the clinical trial, where the implantable sensor provides data to the host data collection system;

collecting data from the implantable sensor at the host data collection system during the clinical trial;

analyzing the data collected at the host data collection system; and

submitting a conclusion of the clinical study based upon the analyzed data to a reviewing authority.

2. The method of claim 1, wherein generating the protocol includes accessing the host data collection system and utilizing a protocol creation module from the host data collection system to interactively create the protocol.

3. The method of claim 2, further comprising submitting the protocol to an investigational review board through the host data collection system.

5. The method of claim 1, further comprising:

monitoring patient compliance with the clinical trial by receiving at the host data collection system an automated indication that a monitored patient has taken a dosage of the drug.

6. The method of claim 5, further comprising providing patient messaging via the host data collection system that provides an indication to the monitored patient to take the drug.

7. The method of claim 1, wherein the implantable sensor is implanted subcutaneously.

8. The method of claim 7, wherein the subcutaneous sensor includes a therapy capability.

9. The method of claim 1, wherein the implantable sensor is implanted via injection.

10. The method of claim 1, wherein the host data collection system reviews the collected data on an on-going basis to identify potential safety issues.

11. The method of claim 1, wherein the host data collection system generates a conclusory reported based upon a host data collection system analysis of the data.

12. The method of claim 1, further comprising:

collecting data a the host data collection center from additional patients having one or more implantable sensors, wherein the additional patients are provided the drug after approval by the FDA.

13. The method of claim 12, further comprising:

monitoring for adverse reactions or trends in the additional patients;

identifying commonalities between additional patients having adverse reactions or trends; and

reporting the commonalities and the adverse reactions or trends.

14. The method of claim 12, further comprising:

monitoring for efficacy in a given patient;

generating a communication from the host data collection system to the given patient indicating a level of efficacy of the drug.

15. The method of claim 14, further comprising:

querying the given patient;

receiving a response at the host data collection center to the query from the given patient; and

updating a database of the host data collection system based upon the received response, wherein the received response provide correlative data regarding the given patient'"'"'s state and the monitored efficacy of the drug.

4. The method of clam 3, further comprising receiving mandated modifications from the investigational review board at the host data collection system, wherein the host data collection system generates a revised protocol for presentation to a sponsor of the study based upon the mandated modifications.

16. An electronic system for conducting a clinical trial for a drug, the system comprising:

a server, the server including;

a protocol module for maintaining a protocol for the clinical trial;

a communication interface for facilitating electronic communication remote from the server; and

a database including a patient record for each of the patients enrolled in the clinical trial for the drug and associated with the electronic system;

a sponsor interface for providing electronic communication between the server and a sponsor of the clinical trial for the drug; and

a plurality of implantable sensors for implantation into a plurality of the patients enrolled in the clinical trial for the drug, wherein the plurality of implantable sensors sense a parameter relevant to an evaluation of the drug in the clinical trial and the parameter is communicated from a given implantable sensor to the server and associated with the patient record in the database corresponding to the given implantable sensor.

17. The system of claim 16, further comprising a protocol creation module accessible via the sponsor interface for generating the protocol based upon information provided to the server through the sponsor interface.

18. The system of claim 16, further comprising a plurality of intermediary devices, wherein a given intermediary devices receives data from the given sensor and transmits the data to the server.

19. The system of claim 18, wherein the intermediary device facilitates two-way communication between a caregiver accessing the server via a caregiver interface and a patient implanted with the given implantable sensor.

20. The system of claim 16, further comprising a safety monitoring module for evaluating data stored within the database for the clinical trial and determining if the data indicates a potential safety issue on an on-going basis.