Integrated data collection and analysis for clinical study

• US 20060224421A1
• Filed: 03/31/2005
• Published: 10/05/2006
• Est. Priority Date: 03/31/2005
• Status: Active Grant

• 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.
• Granted Patent: US 7,594,889 B2
• Time in Patent Office: Days
• US Class Current: 705/4
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: G06Q 40/08 Insurance
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires

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 system comprising:

means for receiving a protocol for conducting a clinical study of a drug;

means for receiving data remotely from a plurality of patients enrolled in the study, wherein at least a portion the received data is received from one or more implantable sensors; and

means for processing the received data according to the protocol to generate a conclusory output indicating a result of a current phase of the clinical study.

2. The system of claim 1, further comprising:

means for interfacing with a study sponsor; and

means for interactively generating the protocol with the study sponsor via the means for interfacing.

3. The system of claim 1, further comprising:

means for generating an investigational new drug application that includes the protocol; and

means for communicating the investigational new drug application to an investigational review board for submission.

4. The system of claim 3, further comprising:

means for receiving data from the investigational review board; and

means for modifying the protocol based upon the data received from the investigational review board.

5. The system of claim 1, further comprising:

means for collecting a patient parameter disposed external to the patient, remote from the means for receiving and in communication with the means for receiving.

6. The system of claim 5, wherein the means for collecting include a sensor for sensing the patient parameter.

7. The system of claim 5, wherein the means for collecting include an interface device in electronic communication with the one or more implantable sensors for providing data from the one or more implantable sensors to the means for receiving as at least a portion of the received data.

8. The system of claim 5, wherein the means for collecting include a communication interface that provides information to a patient enrolled in the clinical study.

9. The system of claim 8, wherein the communication interface provides remote, two-way communication between the patient and a caregiver.

10. The system of claim 1, wherein the one or more implantable sensors include a subcutaneously implanted sensor.

11. The system of claim 10, wherein the subcutaneously implanted sensor includes a loop recorder.

12. The system of claim 10, wherein the subcutaneously implantable sensor provides EKG data.

13. The system of claim 12, wherein the subcutaneously implantable sensor further includes means for defibrillation.

14. The system of claim 1, wherein the one or more implantable sensors include an implantable medical device for providing a therapy and sensing a parameter.

15. The system of claim 14, wherein the implantable medical device includes means for cardiac pacing.

16. The system of claim 14, wherein the implantable medical device includes means for cardiac defibrillation.

17. The system of claim 1, wherein the one or more implantable sensors is selected from the group consisting of:

Temperature Sensor, Heart Rate Sensor, Cardiac Output Sensor, Cardiac Rhythm Sensor, Stroke Volume Sensor, Ejection Fraction Sensor, Pressure Sensor, Implantable External Pressure Reference Sensor, Lung Wetness/Edema Sensor, Oxygen/Oxygen Saturation Sensor, Carbon Dioxide/Carbon Dioxide Saturation Sensor, Respiration Sensor, Transthoracic Impedance Sensor, Minute Ventilation Sensor, C Reactive Protein Sensor, Protein Sensor, Elemental Sensor, pH Sensor, Lead Position Sensor, Lead Integrity Sensor, Cardiac Contractility Sensor, Vascular Dimensional Sensor, Vascular Integrity Sensor, Vascular Topographical Sensor, Cholesterol Sensor, Blood Chemistry Sensor, Salinity Sensor, Dimensional/Volume Sensor, Rhythm Motion Sensor, Cardiac Motion Sensor, Surface EKG Sensor, EGM Sensor, EEG Sensor, Neural Activity Sensor, DNA Analyzer/Sequencer, RNA Analyzer/Sequencer, Fluid Viscosity Sensor, Fluid Flow Senor, Turbulence Sensor, Alcohol Sensor, Insulin Sensor, Glucose Sensor, Lactate Sensor, Hormone Sensor, Human Chorionic Gonadotropin (hCG) Sensor (Pregnancy), Fertility Sensor, Estrogen Sensor, Testosterone Sensor, Adrenaline Sensor, Drug Sensor, Nicotine Sensor, Orientation Sensor, Motion/movement/activity Sensor, Global Location Sensor, Optical Sensor, Imaging Sensor, Acoustic Sensor, Doppler Sensor, Partial Pressure Sensor, Nitric oxide Sensor, Ultrasound Sensor, Ischemia Sensor, Spectral Analyzer, Nerve Conduction Sensor, Stroke Indicator Sensor, Seizure Sensor, Enzyme Sensor, Serotonin Sensor, Cellular State Sensor, Cancer Marker Sensor, Noradrenaline Sensor, Dopamine Sensor, Neurotransmitter Sensor, Neurotransmitter Surrogate Sensor, Hemorrhage Sensor, Ambient/Environmental Sensor, and Magnetic Sensor.

18. The system of claim 1, further comprising means for conducting post market surveillance of the drug via one or more implantable sensors.

19. The system of claim 18, wherein the implantable sensors monitor at least one parameter of a patient not enrolled in the clinical study.

20. The system of claim 1, further comprising means for providing bio-feedback information to a patient using during the post-market surveillance.