System and method for conducting a clinical trial study

• US 20060026034A1
• Filed: 07/28/2004
• Published: 02/02/2006
• Est. Priority Date: 07/28/2004
• Status: Active Grant

• Current Assignee: Cornell Research Foundation Incorporated (Cornell University)
• Original Assignee: David Yankelevitz
• Inventors: Reeves, Anthony P., Yankelevitz, David, Henschke, Claudia
• Granted Patent: US 7,693,729 B2
• Time in Patent Office: Days
• 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 method for conducting a clinical trial, comprising the steps of:

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

transmitting, via a communications network, the medical data and at least one identifier for storage at a remote server, the at least one identifier linking the medical data to a record of the patient;

providing, via the communications network, access to at least portions of the medical data to trial participants based on predefined clinical trial procedures; and

tracking, by the remote server, accessing of the medical data by the trial participants and generation by the trial participants of work product responsive to the medical data.

2. The method according to claim 1, wherein the at least one identifier includes no personal data of the patient.

3. The method according to claim 1, wherein the medical data includes image data of at least a portion of a patient'"'"'s body and wherein the trial participants include a radiologist.

4. The method according to claim 1, wherein the participants to whom access to at least a portion of the medical data is provided include at least one of an image analyzing professional, a patient physician, a monitoring facility and a clinical trial administration group.

5. The method according to claim 4, further comprising the step of:

providing access to the medical data to the patient physician only after work product has been received from the analyzing professional.

6. The method according to claim 1, wherein the step of tracking operations further includes the substep of:

generating and analyzing tracking data to identify delays in conducting the clinical trial.

7. The method according to claim 3, further comprising the step of:

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

8. The method of claim 1, wherein the medical imaging data is generated through a radiology procedure including at least one of 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.

9. The method of claim 1, wherein the at least one identifier includes clinical trial identification data and a facility identifier identfying a medical facility from which medical data was obtained.

10. The method of claim 1, further comprising the step of:

scheduling patient testing in response to the medical data.

11. The method of claim 1, wherein the medical data includes at least one of photographic images, optical projection images and DNA chip images.

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

a server receiving medical data and at least one identifier via a communications 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 and storing the medical data, the database including a list of participants in the clinical trial, the server permitting the participants to access at least a portion of the medical data via the communications network based on a clinical trial procedure and tracking accessing of the medical data by the participants and submission by the participants of work product based on the medical data.

13. The system according to claim 12, wherein the participants include at least one of an image analyzing professional, patient physicians, a monitoring facility and an entity conducting the clinical trial.

14. The system according to claim 12, wherein the server generates tracking data including data indicative of times at which the medical data is accessed by the participants and times at which work product is received from the participants, the server analyzing the tracking data according to the clinical trial procedure to identify delays.

15. The system of claim 12, wherein the medical 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.

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

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

receiving, at a remote server, radiology data and at least one identifier transmitted via a communications network;

storing the radiology data and the at least one identifier in a database, the radiology data including at least one image of at least a portion of a patient'"'"'s body;

providing access, via the communication network, to at least a portion of the radiology data to participants in the clinical trial, the participants including a medical evaluator and a patient physician;

tracking, by the remote server, accessing of the radiology data and generation of work product by the participants in response to the radiology data; and

analyzing tracking data generated in the tracking step according to a clinical trial procedure to identify delays.

18. The method of claim 17, wherein the radiology data is generated by performing at least one of the following procedures:

computerized tomography scan, magnetic resonance imaging, positron emission technology, X-rays, vascular interventional and angiogram/angiography procedures, and ultrasound imaging.

19. The method of claim 17, further comprising the step of:

conducting an initial review of the radiology data by the medical evaluator before providing to the patient physician access to the radiology data.