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.

Description:
BACKGROUND  
       [0001]     Clinical trials of pharmaceutical/medical products are lengthy and expensive due in part to delays resulting from inefficiencies in communications between participants in the trial. For certain products, each day by which the introduction to the market is delayed may cost the pharmaceutical company millions of dollars.  
         [0002]     In a typical case, review and transfer of medical data, such as radiology data (“R/D”) including radiology image data, and related reports as currently handled among clinical trial participants unduly delay the clinical trial process. Typically, participants may transmit the medical data, including image data and related reports, by courier, mail or other document delivery services. Each such communication may delay the progress of the clinical trials by one or more days.  
         [0003]     For example, in the case of radiology images, a radiologist reviews the radiology data and generates a radiologist report. The report is forwarded to a physician for the patient who reviews the radiologist report and makes his own report. The patient physician then forwards both reports along with the radiology data to a monitoring facility for the clinical trial and/or directly to a clinical trial administrator group. The reports along with the corresponding radiology data are reviewed and processed at the respective facilities in accordance with clinical trial protocols and standards.  
       SUMMARY OF THE INVENTION  
       [0004]     The present invention relates to 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. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0005]      FIG. 1  shows an exemplary embodiment of a system of conducting a clinical trial study according to the present invention.  
         [0006]      FIG. 2  shows an exemplary embodiment of a method for conducting a clinical trial according to the present invention.  
         [0007]      FIG. 3  shows an exemplary embodiment of a medical facility medical data record according to the present invention.  
         [0008]      FIG. 4   a  shows an exemplary embodiment of a clinical trial medical data record according to the present invention.  
         [0009]      FIG. 4   b  shows an exemplary embodiment of an updated clinical trial medical data record according to the present invention.  
         [0010]      FIG. 5  shows an exemplary embodiment of a clinical trial protocol according to the present invention.  
     
    
     DETAILED DESCRIPTION  
       [0011]     The present invention may be further understood with reference to the following description of preferred exemplary embodiments and the related appended drawings. It should be understood that, although the preferred embodiment of the present invention will be described with reference to conducting clinical trials using radiology image data, the present invention may be implemented on a wide range of medical data including, for example, photographic image data, optical projection image data, image data of DNA chips, blood test report, etc., and the term “medical data” will be used through out this description to generically refer to all such types of data.  
         [0012]      FIG. 1  shows an exemplary embodiment according to the present invention of a system  1  for conducting a clinical trial study. As it will be explained below in greater details, the system  1  utilizes efficient distribution and tracking techniques to minimize delays generally associated with conducting clinical trials. The system  1  may include one or more participating medical facilities  12  where patients  10  are examined. The medical facility  12  may be, for example, a hospital, a medical clinic, a physician&#39;s private office, etc. Each medical facility  12  may include one or more sources (e.g., medical equipment, medical personal) for collecting the patient&#39;s  10  medical data  204 . For example, the medical facility  12  may have a radiology imaging device  9  obtaining imaging data of at least one a portion of a patient&#39;s body. After the patient  10  is examined at the medical facility  12 , the medical data  204  is collected and stored in a digital format as a Medical Facility Medical Data Record (“MFMDR”)  200 , as shown in  FIG. 3  and further described below. The MFMDR  200  is then transmitted to a remote facility  50  via, for example, a communications network  20  (e.g., the Internet, a Wide Area Network).  
         [0013]     The system  1  may also include a physician  8 , a medical evaluator  22 , a monitoring facility  14 , and a clinical trial administration group (“CTAG”)  16 . The physician  8  may be responsible for examining the patient  10 , diagnosing and prescribing treatments. The medical evaluation  22  reviews and interprets the medical data  204 . In this exemplary embodiment, the radiological data would preferably be interpreted by a radiologist. The medical evaluator  22  may remote access the medical data  204  and then remotely submit the report.  
         [0014]     The monitoring facility  14  may include a governmental agency like the U.S. Food and Drug Administration or other interested parties or sponsoring organizations. Alternatively, the monitoring facility  14  may include a clearinghouse that conducts and maintains the clinical trial study (e.g., for conducting day-to-day operations) which is initially defined by the CTAG  16 . For example, the CTAG  16  may set up parameters, timelines and deadlines that the clinical trial study should operate in accordance with and which are monitored by the monitoring facility  14 . Alternatively, the CTAG  16  may conduct the clinical trial study itself. However, as understood by those skilled in the art, the monitoring facility  14  may conduct the entire study and provide periodic reports to the CTAG  16 .  
         [0015]     The CTAG  16  may, for example, include a pharmaceutical company, a medical device company, and/or a research group/organization. In one embodiment mentioned above, the CTAG  16  may conduct the clinical trial study itself. In an alternative embodiment as mentioned above, the CTAG  16  may develop the clinical trial study, which will be implemented and monitored by the monitoring facility  14 . The present invention allows for the CTAG  16  to more closely track the progress of the clinical trial study.  
         [0016]     The remote facility  50  may, for example, include one or more servers  24  connected to one or more databases  26  where medical data  204  is stored. The remote facility  50  serves as a central facility where the medical data  204  from all participating patients  10  is stored and processed. The remote server  24  also provides participants of the trial study with an access to the medical data  204 . The remote server  24  may, for example, notify participants of arrival of new medical data  204  and track the progress of the clinical trial study.  
         [0017]      FIG. 2  shows an exemplary embodiment of a method of conducting a clinical trial study. In the step  102 , the medical data  204  is collected at a medical facility  12  to generate the MFMDR  200 . Examinations to collect the medical data  204  may, for example, be performed by medical devices and/or medical facility personnel of the medical facility  12 . Such devices may, for example, include 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, medical genetic imaging and DNA imaging. Subsequent to the examination, the MFMDR  200  for the examined patient  10  is generated.  
         [0018]     An exemplary embodiment of the MFMDR  200  is illustrated in  FIG. 3 , which, for example, may include, patient identification and personal information  202  (e.g., patient&#39;s name, address, social security number, date of birth, medical history, etc.), the medical data  204 , a medical data type  206  (e.g., the medical data  204  includes CAT scan, etc.), examination date  208  (e.g., the medical data  204  was collected on May 1, 2004 at 2 p.m.), and a medical facility identifier  210  (e.g., the medical data  204  was collected by the medical facility  12 ). The medical data  204  may include a plurality of medical related such radiological data, pathology data, etc.  
         [0019]     In step  104 , the medical facility  12  determines if the patient  10  participates in any clinical trial studies. The medical facility  12  checks the patient identification information  202  against its internal database which stores a list of patients enrolled in the clinical trial studies. If the patient  10  does not participate in any clinical trials, the MFMDR  200  is stored at the medical facility  12  and no further steps need to be taken. However, if the patient  10  does participate in one or more clinical trials, the MFMDR  200  is utilized to generate a Clinical Trial Medical Data Record (“CTMDR”)  212  for the patient  10  (step  106 ).  
         [0020]     An exemplary embodiment of the CTMDR  212  generated by the medical facility  12  is shown in  FIG. 4   a . The CTMDR  212  includes an unique patient identification  214 , the medical data  204 , the medical data type  206 , the examination date  208 , the medical facility identifier  210  and a clinical trial study identifier  216 . During this process, the personal information  202  (e.g., name, address, social security number) of the patient  10  is at least partially removed and replaced with the unique patient identification  214 . The unique patient identifier  214 , for example, may be randomly generated by the CTAG  16 . The unique identifier  214  provides anonymity during the transfer the CTMDR  212 , preserves the patient&#39;s privacy and complies with government privacy regulations, such as, for example, the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  
         [0021]     The HIPAA imposes national standards for electronic health care transactions and national identifiers for providers, health plans, and employers. The HIPAA also mandates regulations for the security and privacy of health data. The present invention provides a system compatible with privacy requirements for handling the widespread use of electronic data interchange in health care.  
         [0022]     In step  108 , the CTMDR  212  is then forwarded to the remote server  24  via the communications network  20  where it is stored in the database  26  and accessible by authorized participants of the clinical study such the physician  8 , the medical evaluators  22 , etc. In step  110 , the CTAG  16  is notified that the CTMDR  212  is transmitted to and received by the remote server  24 . As would be understood by those skilled in the art, notification to the CTAG  16  may be provided by a transmittal notification from the medical facility  12  or a receipt notification from the remote server  24 .  
         [0023]     Upon the notification that the CTMDR  212  has been received by the remote server  24 , the CTAG  16  and/or the remote server  24  may perform initial evaluation to determine if the medical data  204  of the CTMDR  212  is suitable for further review/evaluation (step  112 ). For example, the CTAG  16  may have in-house resources to perform the initial review on the CTMDR  212  for completeness. Alternatively, the remote server  24  may have a plurality of software modules that evaluate the medical data  204 . For example, the CTMDR  212  may be unsuitable for further review/evaluation because the CTMDR  212  may be technically and/or clinically unusable. A technically unusable CTMDR  212  may include unclear information, partially damaged or corrupted files, or any other condition that would make the CTMDR  212  unreadable, unaccessible or technically unusable. A clinically unusable CTMDR  212  may indicate that the patient  10  is unsuitable for the clinical trial. For example, a specific clinical trial may require information from patients who suffer from tumors with diameters of 5 cm or larger; therefore, data from a patient with a tumor of 4.5 cm in diameter would be clinically unusable for this particular clinical trial.  
         [0024]     In step  114 , access of the authorized participants to the unsuitable CTMDR  212  may be restricted by the CTAG  16 . Simultaneously, a request for transmittal or recollection of data may be sent to the medical facility  12 . One of the advantages of the present invention is that it eliminates a waste of resources for the evaluation if unusable medical data and expedites collection of the replacement medical data.  
         [0025]     Upon receipt of the suitable CTMDR  212 , the remote server  24  notifies and provides access to the CTMDR  212  to the authorized participants of the clinical trial study (step  116 ). In step  118 , each of the authorized participants accesses and reviews the CTMDR  212 . Upon the review, the authorized participant generates a diagnostic report which is forwarded to the remote server  24 . The remote server  24  receives the diagnostic report and generates an updated CTMDR  218  (as shown in  FIG. 4   b ). The remote server  24  also may send a receipt notification to the CTAG  16  that the updated CTMDR  218  was received.  
         [0026]     There may not be a specified order of the review of the CTMDR  212  by the authorized participants. For example, the physician  8  and the medical evaluator  22  may access and evaluate the CTMDR  212  at the same time. Alternatively, the physician  8  may review the medical data  204  only after the medical evaluator  22  has submitted the diagnostic report. At this point, the physician  8  may access to the updated CTMDR  218 , which includes the diagnostic report  218  of the medical evaluator  22 , to further evaluate the medical data  204 .  
         [0027]     The present invention further allows the CTAG  16  to more closely track the progress of the clinical trial study. In particular, prior to the client trial study, the CTAG  16  may formulate a clinical trial protocol (“CTP”)  300 , as seen in  FIG. 5 . The CTP  300  may include the clinical trial study identifier  216 , a CTAG identification  302 , a preset procedure  304 , an authorized participant information  306  (e.g., an identifier of the physician  8 , the medical evaluator  22 , etc.), and a preset clinical trial schedule  308 . In other words, the CTP  300  provides a guideline for conducting the clinical study which is implemented by the remote server  24 . The CTP  300  may be updated by the CTAG  16  at anytime before or during the clinical trial study.  
         [0028]     The clinical trial study identification  216  is the same as that which appears on the CTMDR  212  and updated CTMDR  218 . The clinical trial study identification  216  allows the CTAG  16  to differentiate between clinical trial studies, in the event that it is conducting multiple studies. Typically, the CTAG  16  determines the clinical trial study identification  216 , which may take the form of a number, word, alphanumeric identifier or phrase. Alternatively, the CTAG  16  may provide the clinical trial study identification  216  to the remote server  24 , which generates its own identification  216 .  
         [0029]     The CTAG identification  302  included in the CTP  300  allows the remote server  24  to differentiate between and correspond with multiple CTAGs  16  in the event that it is conducting multiple clinical trial studies simultaneously and for multiple CTAGs  16 . The CTAG identification  302  may be generated by the remote server  24  or the CTAG  16 .  
         [0030]     The CTP  300  may further include the preset procedures  304  and the preset schedule  308  which defined the schedule and procedure of the clinical trial study. The preset procedures  304  and the preset schedule  308  are specified by the CTAG  16  based on desired goals and specifics of the study. For example, the CTAG  16  may want the medical evaluator  22  to add its diagnostic report  218  to the CTMDR  212  before the physician  8  conducts his/her evaluation; the CTAG  16  may want to review the CTMDR  212  before the physician  8  so the CTAG  16  can ask questions based on the CTMDR  212 . Also, the CTAG  16  may have specified a time limit for the clinical trial study, or time limits for review by the medical evaluator  22  and/or physician  8 . As would be understood by those skilled in the art, the preset procedures  304  and the preset schedule  308  are customizable based on the desires of the CTAG  16 . The CTAG  16  may specify that when reminders to collect or review the medical data  204  must be sent to corresponding parties. The CTAG  16  may also set up due dates for follow up examinations of the patient  10 .  
         [0031]     Further included in the CTP  300  is the authorized participant information  306 . The authorized participant information  306  may include the authorized participant&#39;s identification, a time for accessing the CTMDR  212  or updated CTMDR  218 , and/or a time for reporting based on the CTMDR  212  or updated CTMDR  218 . As would be understood by those skilled in the art, the authorized participant information  306  may further include as many or as few categories as the CTAG  16  deems necessary.  
         [0032]     The authorized participant information  306  allows the remote server  24  to track the progress of the clinical trial study. For example, tracking data may be generated by monitoring the timing of access to the CTMDR  212  by authorized participants. The remote server  24  may compare the actual times of access with those in the preset schedule  308  to generate a progress report identifying delays and pointing to potential sources of the delay. For example, if the medical evaluator  22  is allotted 2 days to examine one CTMDR  212 , any time taken over the allotted amount may be noted in the progress report generated by the remote server  24 . Also, the remote server  24  may send a reminder notification or delay notice to the participant and the CTAG  16 . The progress report may further include instances where action was taken early. For example, if the medical evaluator completes review of several CTMDRs  212  in one day, this will be noted on the progress report. This tracking feature may allow the CTAG  16  to accurately assess delays in the clinical trial study and tailor incentives and/or penalties for the authorized participants. While the tracking feature has been described as being conducted by the remote server  24 , those skilled in the art would understand that the CTAG  16  and/or the monitoring facility  14  may track the clinical trial study.  
         [0033]     Some of the CTAG guidelines/procedure may be generated during the study in the response to results obtained up to that particular point in the study. For example, results from the radiological data may generate predictions or recommendations for scheduling future patient testing based on a look up table of test results versus test schedules or other predetermined criteria.  
         [0034]     While specific embodiments of the invention have been illustrated and described herein, it is realized that numerous modifications and changes will occur to those skilled in the art. It is therefore to be understood that the appended claims are intended to cover all such modifications and changes as fall within the true spirit and scope of the invention.