System and method for conducting a clinical trial study

• US 7,693,729 B2
• Filed: 07/28/2004
• Issued: 04/06/2010
• Est. Priority Date: 07/28/2004
• Status: Active Grant

• Current Assignee: Cornell Research Foundation Incorporated (Cornell University)
• Original Assignee: Cornell Research Foundation Incorporated (Cornell University)
• Inventors: Reeves, Anthony P., Yankelevitz, David, Henschke, Claudia
• Primary Examiner(s): O'Connor; Gerald J.
• Assistant Examiner(s): NGUYEN, HIEP VAN
• Application Number:
  US10/901,362
• Publication Number:
  US 20060026034A1
• Time in Patent Office: 2,078 Days
• Field of Search: 705/2, 705/1, 705/3
• US Class Current: 705/2
• 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

Abstract

Described is a method and system for conducting a clinical trial. Medical data is obtained from a patient participating in the clinical trial. Then, the medical data and at least one identifier are transmitted, via a communications network, for storage at a remote server. The at least one identifier links the medical data to a record of the patient. Access to at least portions of the medical data is provided, via the communications network, to trial participants based on predefined clinical trial procedures. The remote server tracks accessing of the medical data by the trial participants and generation by the trial participants of work product responsive to the medical data.

Claims

1. A system for conducting a clinical trial, comprising:

a server, in communication with the Internet or a Wide Area Network for receiving medical data, where the medical data includes image data and at least one identifier via the Internet or a Wide Area Network, the at least one identifier including an identifier linking the medical data to patient records corresponding to patients from whom the medical data was obtained; and

a database connected to the server for storing the medical data, the database including a list of participants in the clinical trial, where the participants are also coupled to the Internet or a Wide Area Network;

a clinical trial protocol including a plurality of preset procedures implemented in the server, where the clinical trial protocol also includes authorized participant information that allows the server to track the progress of the clinical trial study and operate to permit the participants to access the medical data via the Internet or a Wide Area Network; and

a time tracker implemented in the remote server to track times of accessing of the medical data and times of reporting the medical data by the participants and compare actual times of access and reporting with those in a preset schedule to generate a progress report identifying delays and pointing to potential sources of the delay according to the clinical trial protocol, where transmission of the medical data and the image data is in compliance with privacy requirements for handling electronic data interchange in health care, wherein the participants include an image analyzing professional, a patient physician, a monitoring facility and a clinical trial administration group each of which are linked to the server to receive medical data through the Internet or a Wide Area Network.

2. The system according to claim 1, wherein the server generates tracking data including data indicative of times at which work product is received from the participants.

3. The system of claim 1, wherein the image data is generated by performing at least one of the following procedures:

a computerized tomography scan, magnetic resonance imaging, positron emission technology, X-rays, vascular interventional and angiogram/angiography procedures, ultrasound imaging, radiographs, optical imaging, pathological imaging, molecular imaging, and medical genetic imaging.

4. The system of claim 1, wherein the image data includes at least one of photographic images, optical projection images and DNA chip images.

5. A method for conducting a clinical trial, comprising the steps of:

generating image data of at least a portion of a patient'"'"'s body using a medical imaging device to perform at least one examination, where the medical imaging device is in a medical facility linked to the Internet or a Wide Area Network;

obtaining additional medical data from a patient participating in the clinical trial;

transmitting the additional medical data and the image data, through the Internet or a Wide Area Network link to a remote server, where the additional medical data includes at least one identifier, where transmission of the medical data and the image data is in compliance with privacy requirements for handling electronic data interchange in health care;

storing the additional medical data and the image data in a database accessible by the remote server in a medical data record, where the at least one identifier links the medical data record to the patient identification;

operating the remote server to implement a clinical trial protocol including a plurality of preset procedures for conducting the clinical study;

operating the remote server to give authorized participants Internet or Wide Area Network access to the medical data record according to schedules and procedures as defined by the clinical trial protocol, wherein the authorized participants include an image analyzing professional, a patient physician, a monitoring facility and a clinical trial administration group; and

operating the at least one remote server to track times of accessing of the medical data and times of reporting the medical data by the participants and compare actual times of access and reporting with those in a preset schedule to generate a progress report identifying delays and pointing to potential sources of the delay according to the clinical trial protocol; and

operating the at least one remote server to track progress of the clinical trial and transmission of the additional medical data and the image data according to the clinical trial protocol.

6. The method according to claim 5, wherein the at least one identifier includes no personal data of the patient.

7. The method according to claim 5, further comprising the step of providing access to the medical data record to the patient physician only after work product has been received from the image analyzing professional.

8. The method according to claim 5, further comprising the step of:

generating tracking data indicative of when the medical data record was accessed and when work product was generated.

9. The method of claim 5, wherein the medical imaging device performs a radiology procedure selected from the group consisting of a computerized tomography scan, magnetic resonance imaging, positron emission technology, X-rays, vascular interventional and angiogram/angiography procedures, ultrasound imaging, radiographs, optical imaging, pathological imaging, molecular imaging, and medical genetic imaging.

10. The method of claim 5, wherein the at least one identifier includes clinical trial identification data and a facility identifier identifying a medical facility from which medical data was obtained.

11. The method of claim 5, further comprising the step of:

scheduling patient testing in response to information in the medical data record.

12. The method of claim 5, wherein the medical data record includes at least one of photographic images, optical projection images and DNA chip images.