Abstract:
A system and method for processing clinical trial data in a network communication environment according to a trial protocol. The trial protocol defining a plurality of data quality requirements and analysis functions for use in processing the clinical trial data, the method comprising: accessing a plurality of the trial protocols defining a plurality of respective clinical trials; receiving an update from the communication network for said trial protocol of the plurality of trial protocols, the update for amending at least one of the data quality requirements or analysis functions; receiving a trial dataset from the communication network having a trial ID for identifying at least one of the plurality of the trial protocols, the trial dataset including patient image data and identification data for at least one originator of the patient image data; matching the trial ID to the updated trial protocol from said plurality of trial protocols and selecting the updated trial protocol for use in processing the received trial dataset; determining through a data processing module a deficiency in the patient images of the received trial dataset as contradicting at least one of the data quality requirements or analysis functions of the updated trial protocol; and sending a request over the communications network for eventual receipt by the originator of the received trial dataset for a revised set of the received trial dataset, the request including information regarding the determined deficiency.

Description:
BACKGROUND 
       [0001]    There is a need for monitoring the adherence to standards for data acquisition and data processing of data related to clinical trials. Further, there is a need for facilitating the operation of a data analysis system for accepting clinical trial data relating to more than one clinical trial, as well as for matching anonymized image data with anonymized textual data relating to a specific patient. 
       SUMMARY 
       [0002]    The systems and methods disclosed herein provide a clinical trial data processing environment to obviate or mitigate at least some of the above-presented disadvantages. 
         [0003]    A first aspect provided is a method for processing clinical trial data in a network communication environment according to a trial protocol, the trial protocol defining a plurality of data quality requirements and analysis functions for use in processing the clinical trial data, the method comprising: accessing a plurality of the trial protocols defining a plurality of respective clinical trials; receiving an update from the communication network for said trial protocol of the plurality of trial protocols, the update for amending at least one of the data quality requirements or analysis functions; receiving a trial dataset from the communication network having a trial ID for identifying at least one of the plurality of the trial protocols, the trial dataset including patient image data and identification data for at least one originator of the patient image data; matching the trial ID to the updated trial protocol from said plurality of trial protocols and selecting the updated trial protocol for use in processing the received trial dataset; determining through a data processing module a deficiency in the patient images of the received trial dataset as contradicting at least one of the data quality requirements or analysis functions of the updated trial protocol; sending a request over the communications network for eventual receipt by the originator of the received trial dataset for a revised set of the received trial dataset, the request including information regarding the determined deficiency. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0004]    These and other features will become more apparent in the following detailed description in which reference is made to the appended drawings wherein: 
           [0005]      FIG. 1  is a block diagram of a communication network system for clinical trials; 
           [0006]      FIG. 2  is an example workflow of the clinical trial of  FIG. 1 ; and 
           [0007]      FIG. 3  is a block diagram of a generic computing device for implementing operations of the workflow of  FIG. 2 . 
       
    
    
     DESCRIPTION 
       [0008]    Referring to  FIG. 1 , a communication network system  10  comprises a plurality of trial sponsors  12  (e.g. different sponsors S 1 , S 2 , S 3 , S 4 ) for supporting a plurality of respective clinical trials involving data obtained from a plurality of trial eligible patients/subjects  100  (see  FIG. 2 ). The trial sponsors  12  are responsible for defining the clinical trials by specifying implementation considerations and financial considerations of the clinical trials through corresponding trial protocols  14   a,b,c,d , the considerations being such as but not limited to: characteristics and requirements that determine operation of data quality control functions within the system  10 ; operational procedures of data acquisition (e.g. authorized imaging systems) in predetermined format(s); desired reporting  23  of the clinical trial results and methods of data analysis; and type and quantity of data desired (e.g. images of selected anatomy regions, answers to selected questions, measured clinical parameters such as blood pressure and age/sex, etc.). The sponsors  12  can use the services of a trial manager  16  (e.g. TM 1 , TM 2 ) for managing the implementation of trial protocols  14   a,b,c,d , including: selection of one or more trial sites  18  (e.g. TS 1 , TS 2 , TS 3 , TS 4 ) for collection of the data for specific clinical trials under the jurisdiction of the respective trial manager  16 ; and selection of one or more data analysis sites  20  (e.g. imaging core labs), such as DA 1  and DA 2 , for analysis of collected trial data  22  received from the trial sites  18 . The trial sites  18  can be such as but not limited to clinics, hospitals, and other health care facilities with appropriate technical infrastructure to acquire the trial data  22 . The data analysis sites  20  are responsible for processing the each of the collected trial data  22  according to the respective trial protocol  14   a,b,c,d  in order to generate a respective trial report (e.g. R 1 , R 2 , R 3 , R 4 ), as further described below. Accordingly, it is recognized that one data analysis site  20  can be responsible for analyzing (and reporting on) trial data  22  received for multiple different clinical trials. It is recognized that the trial managers  16 , the trial sites  18 , and the data analysis sites  20  can be interconnected by a network  11 , as desired. 
         [0009]    Referring to  FIG. 2 , shown is an example workflow of the network system  10  for a selected combination of trial sponsor  12 , trial manager TM 1 , trial site TS 1 , and data analysis site DA 1 . The sponsor  12  decides upon the general operating parameters of the trial protocol  14   a  and provides this to the trial manager TM 1 , which stores 100 the trial protocol  14   a  (with other trial protocols  14   b,c,d  where applicable). It is noted that the trial manager TM 1  may be responsible for one or more trials, as desired. The trial protocol  14   a  is labeled with a unique identifier  24 , also referred to as a trial ID, in order to distinguish this trial from the other trials being conducted (for example by the trial manager TM 1  or other managers  16  as desired). The trial manager TM 1  selects  102  the trial site TS 1  (and others as desired) to be used for collection of the trial data  22  required by the trial protocol  14   a . Once selected, the trial manager TM 1  can provide training for the selected trial site TS 1  in order to help ensure (e.g. using a certification process) that the trial site TS 1  personnel and data collection facilities are adequate/enabled  104  for acquiring the required trial data  22  (i.e. according to the trial protocol  14   a ). 
         [0010]    Once enabled, the trial site TS 1  acquires  106  data patient data  27  from eligible patients  26  (including patient image and/or patient non-image data) in view of the trial protocol  14   a  (e.g. facilitates quality control of the image and textual patient data  27 ) and assigns the corresponding trial ID  24  to the collected patient data  27 . It is recognized that the patient data  27  can contain both personal data  28  (e.g. patient name, patient identifier, patient address, patient contact information, patient medical insurance information, healthcare provider identification information, and other information usable to help uniquely identify the particular patient used to collect the patient data  27 ) and general or non-specific data  30  (e.g. medical images, answers to trial questionnaires, and other information that cannot be used to help uniquely identify the particular patient and/or health care provider used to collect the patient data  27 ). The trial site TS 1  can use various imaging modalities (CT, MR, X-ray, ultra-sound, etc.) and imaging procedures and parameters that will produce patient images in an acceptable manner as specified in the trial protocol  14   a . The use of a consistent set of parameters as specified in the trial protocol  14   a  facilitates comparability of the images and textual data within a clinical trial. It is recognized that the acquired images in the patient data  27  are suitable for storage in a digital format (also definable by the trial protocol  14   a  as desired). Further, it is recognized that the textual portion of the patient data  27  is also suitable for storage in a digital format (also definable by the trial protocol  14   a  as desired). 
         [0011]    The trial site TS 1  also anonymizes  108  (using automatic data parsing, manual data parsing, or a combination thereof) the patient data  27  collected in order to remove or otherwise obscure (e.g. renders the patient identity anonymous) all of the personal data  28  while retaining the non-specific data  30  required by the trial protocol  14   a . Once anonymized, the patient data  27  becomes the clinical trial data  22 . It is recognized that the trial ID  24  can be attached to the patient data  27 , the personal data  28 , the non-specific data  30 , the clinical trial data  22 , or a combination thereof and the data  27 , 28 ,  30 ,  22  with associated trial ID  24  can be stored  110  in storage of the trial site TS 1 . It is recognized that the specific manner in which the patient data  27  is anonymized can be defined in the trial protocol  14   a , as desired. The anonymization process can include operations (defined in the trial protocol  14   a ) such as but not limited to: removal of data fields from the patient data  27  that are part of image header; substitution of data values in the patient data  27  based on controlled vocabularies; and/or removal or substitution of data in patient images. 
         [0012]    Further, it is recognized that the clinical trial data  27  can also be assigned a file ID (e.g. at the anonymizer step  108 ) that can be used to track selected clinical trial data  27  for selected patients or groups of patients who have been anonymized. Further, it is recognized that a trial site ID can be assigned (e.g. at the storage step  110 ) to the clinical trial data  27  for facilitating monitoring of performance of the individual trial sites  18  used to generate the clinical trial data  27 . Any of the IDs can be included with the trial data  22  that is communicated or otherwise made available to the data analysis sites  20 , as desired. 
         [0013]    The trial data  22  (with attached trial ID  24 ) is then sent  112  over the network  11  (e.g. an intranet or an extranet such as the Internet) to the remote data analysis site  20  in order for analysis of the non-specific data  30  included in the clinical trial data  22 . Once received, the trial data  22  (containing image and non-image data if desired by the trial protocol  14   a ) is reviewed  114  to automatically identify the included trial ID  24 , and then the trial data  22  is assigned to the respective clinical trial (i.e. the trial data  22  is matched with the appropriate trial protocol  14   a ). It is recognized that the trial data  22  can be received from multiple different trial sites  18 . Accordingly, the data analysis site  20  can: select the appropriate trial protocol  14   a  (in this case) from a plurality of known trial protocols stored locally at the data analysis site  20 ; access the appropriate trial protocol  14   a  via a network address associated with the trial ID  24  (e.g. request the trial protocol  14   a  from the trial manager TM 1  over the network  11  using the network address); or a combination thereof. It is recognized that the review process  114  of the received trial data  22  can also be used to examine the trial data  22  for quality control purposes (also potentially defined by the trial protocol  14   a ), as further described below. 
         [0014]    Once the appropriate trial protocol  14   a  is known for the received trial data  22 , the trial data  22  is set-up/prepared  116  for reading/analysis  118  by trained analysts  31 , in order to facilitate consistency of the trial data  22  for the reading  118  step. The preparation  116  of the clinical trial data  22  can include actions such as but not limited to: image zoom; image pan; selected image views; image measure; cropping specific regions of interest from larger imaged regions of the patient  26 ; other standardization operations of included patient images (e.g. specified image sizes, image orientations, image enhancements); associate a randomized ID for the included image(s); and/or put included textual information obtained from the patient (age, sex, questionnaire answers, etc.) into a desired format. It is recognized that the specific manner in which the received trial data  22  is prepared  116  can be defined in the trial protocol  14   a , as desired. Further, it is recognized that specific procedures/protocols in processing the format of the data  22  for the preparation step  116  can be different from the procedures used to format the acquired data  27  at step  106 , thus demonstrating the dynamic updatable nature of the trial protocol  14   a  to change the emphasis on certain portions of the data  22  during conducting of the respective clinical trial (e.g. changes to the protocol  14   a  occur after the trial site  18  has been trained  104  or has otherwise produced the data  27 ). 
         [0015]    It is also recognized that the steps  114  and/or  116  could log their findings on the quality and/or timeliness of the received data  22 , for example in comparison with the trial protocol  14   a , including the content and frequency of the messages  122 , 123  to the trial site  18 , and thus monitor the performance of the individual trial sites  18  with respect to the received data  22 . The data analysis site  20  could decide which trial site(s)  18  to accept the trial data  22  from based on the determined performance of the trial sites  18 . 
         [0016]    Once the trial data  22  has been prepared  116 , the analysts  31  analyze  118  the trial data  22  according to the trial protocol  14   a , in order to complete the reports  23  generated  120  according to report definitions included in the trial protocol  14   a . This analysis  118  step is used to identify desired clinical information from the trial data  22  and to include this desired clinical information in the reports  23 , e.g. analyze the trial data  22  to select and determine parameters for use in evaluating progress of the clinical trial. Further, the analysis  118  can include conducting statistical analysis of the trial data  22  according to predefined statistical analysis parameters in the trial protocol  14   a.    
         [0017]    In the generation  120  of the reports  23 , it is recognized that the desired clinical information, and desired report format thereof, is defined in the trial protocol  14   a . The analysts  30  can be human (e.g. effecting a manual analysis of the prepared clinical trial data  22 ) according to a predefined set of analysis procedures/steps; an analysis software (e.g. effecting an automated analysis of the prepared clinical trial data  22 ); or a combination thereof. 
         [0018]    Accordingly, in view of the above described example operation of the network system  10 , it is recognized that the inclusion of the trial ID  24  in the trial data  22  facilitates automatic recognition by the data analysis site  20  of which clinical trial the trial data  22  should be associated with. In this capacity, any data analysis site  20  can be configured for processing of trial data  22  obtained from multiple trial sites  18 , which are used for multiple respective clinical trials. Through the trial ID  24 , the data analysis site  20  matches the appropriate trial protocol  14   a,b,c,d  to the trial data  22 , in order to assist in appropriate processing of the trial data  22  to result in desired reports  23  intended for review by the respective trial sponsor  12 . It is recognized that the trial protocol  14   a,b,c,d  corresponding to the received trial data  22  can be communicated to the data analysis site  20  during setup of the clinical trial (e.g. the data analysis site  20  is selected by the trial manager  16 ) and/or remotely accessed over the network  11  in response to identifying the corresponding trial ID from the received trial data  22 . It is recognized that the trial manager  16  can also communicate (or otherwise make available) synchronously and/or asynchronously any updates of the trial protocol  14   a,b,c,d  to the sites  18 ,  20 , as desired, including predefined parameters for coordinating standardized data acquisition and data processing by the trial site TS 1  and the data analysis site DA 1  as noted above. 
         [0019]    Referring to  FIG. 3 , each of the above-described operations  106 ,  108 ,  110 ,  112 ,  114 ,  116 ,  118 ,  120  can be implemented on a respective computing device  101 . The devices  101  in general can include a network connection interface  200 , such as a network interface card or a modem, coupled via connection  218  to a device infrastructure  204 . The connection interface  200  is connectable during operation of the devices  100  to the network  11 , which can enable the devices  101  to communicate with each other, the sponsor  12 , and the trial manager  16 , as appropriate. The network  11  supports the transmission of the trial data  22  between the sites  18 ,  20 , the reports  23  between the data analysis site  20  and the sponsor  12  (or trial manager  16 ), the trial protocol  14   a,b,c,d  (and any updates/changes thereto) between the sponsor  12  and the trial managers  16 , as well as between the trial managers  16  and the sites  18 , 20 . 
         [0020]    Referring again to  FIG. 2 , the devices  101  also have a user interface  202 , coupled to the device infrastructure  204  by connection  222 , to interact with a user (not shown). The user interface  202  includes one or more user input devices such as but not limited to a QWERTY keyboard, a keypad, a trackwheel, a stylus, a mouse, a microphone and the user output device such as an LCD screen display and/or a speaker. If the screen is touch sensitive, then the display can also be used as the user input device as controlled by the device infrastructure  204 . The user interface  202  is employed by the user of the device  101  to coordinate the respective processing of data  27 , 22  at various stages of the above described clinical trial workflow (including data acquisition) as facilitated by application programs/hardware  302  configured to administer the respective portions of the trial protocols  14   a,b,c,d  for the respective operations  106 ,  108 ,  110 ,  112 ,  114 ,  116 ,  118 ,  120 . 
         [0021]    Referring again to  FIG. 2 , operation of the device  101  is enabled by the device infrastructure  204 . The device infrastructure  204  includes a computer processor  208  and an associated memory module  210 . The computer processor  208  manipulates the operation of the network interface  200 , the user interface  202  and the application programs/hardware of the device  101  by executing related instructions, which can be provided by an operating system located in the memory module  210 . The computer processor  208  facilitates performance of the device  101  configured for the intended task (e.g. suitable modules/processors for the respective operations  106 ,  108 ,  110 ,  112 ,  114 ,  116 ,  118 ,  120 ) through operation of the network interface  200 , the user interface  202  and other application programs/hardware of the device  101  by executing task related instructions. These task related instructions can be provided by the operating system, and/or software applications (e.g. executable instructions  302 ) located in the memory  210 , and/or by operability that is configured into the electronic/digital circuitry of the processor(s)  208  designed to perform the specific task(s). Further, it is recognized that the device infrastructure  204  can include a computer readable storage medium  212  coupled to the processor  208  for providing instructions to the processor  208  and/or to load/update client application programs  302  in the memory module  210 . The computer readable medium  212  can include hardware and/or software such as, by way of example only, magnetic disks, magnetic tape, optically readable medium such as CD/DVD ROMS, and memory cards. In each case, the computer readable medium  212  may take the form of a small disk, floppy diskette, cassette, hard disk drive, solid-state memory card, or RAM provided in the memory module  210 . It should be noted that the above listed example computer readable mediums  212  can be used either alone or in combination. 
         [0022]    Further, it is recognized that the computing devices  101  can include an executable application program  302  comprising code or machine readable instruction for implementing predetermined functions including those of an operating system, healthcare information system or other information processing system, for example, in response user command or input as defined by the appropriate trial protocol  14   a,b,c,d  (for example). The processor  208  as used herein is a device and/or set of machine-readable instructions  302  for performing operations as described by example above. As used herein, the processor  208  may comprise any one or combination of, hardware, firmware, and/or software. The processor  208  acts upon information by manipulating, analyzing, modifying, converting or transmitting information for use by an executable procedure or an information device, and/or by routing the information to an output device. The processor  208  may use or comprise the capabilities of a controller or microprocessor, for example. Further, any of the functions provided by the systems and process of  FIGS. 1-2  may be implemented in hardware, software or a combination of both. Accordingly, the use of a processor  208  as a device and/or as a set of machine-readable instructions  302  is hereafter referred to as the processor for sake of simplicity. 
         [0023]    It will be understood by a person skilled in the art that the storage/database  210  of the computer devices  101  (as well as any communal storage—not shown—for any of the trial sites  18  and/or data analysis sites  20 ) described herein is the place where data is held in an electromagnetic or optical form for access by a computer processor. There are a number of different embodiments: One, can mean the devices and data connected to the computer through input/output operations such as hard disk and tape systems and other forms of storage not including computer memory and other in-computer storage. Second, in a more formal usage, storage can been divided into: (1) primary storage, which holds data in memory (sometimes called random access memory or RAM) and other “built-in” devices such as the processor&#39;s L1 cache, and (2) secondary storage, which holds data on hard disks, tapes, and other devices requiring input/output operations. Primary storage can be much faster to access than secondary storage because of the proximity of the storage to the processor or because of the nature of the storage devices. On the other hand, secondary storage can hold much more data than primary storage. In addition to RAM, primary storage can include read-only memory (ROM) and L1 and L2 cache memory. In addition to hard disks, secondary storage can include a range of device types and technologies, including diskettes, Zip drives, redundant array of independent disks (RAID) systems, and holographic storage. Devices that hold storage are collectively known as storage media. 
         [0024]    A database is a further embodiment of storage as a collection of information that is organized so that it can easily be accessed, managed, and updated. In one view, databases can be classified according to types of content: bibliographic, full-text, numeric, and images. In computing, databases are sometimes classified according to their organizational approach, such as a relational database being a tabular database in which data is defined so that it can be reorganized and accessed in a number of different ways. A distributed database is one that can be dispersed or replicated among different points in a network. An object-oriented programming database is one that is congruent with the data defined in object classes and subclasses. 
         [0025]    Computer databases can contain aggregations of data records or files, such as sales transactions, product catalogs and inventories, and customer profiles. Typically, a database manager of the storage provides users the capabilities of controlling read/write access, specifying report generation, and analyzing usage. Databases and database managers are prevalent in large mainframe systems, but are also present in smaller distributed workstation and mid-range systems such as the AS/400 and on personal computers (e.g. devices  101 ). SQL (Structured Query Language) is a standard language for making interactive queries from and updating a database such as IBM&#39;s DB2, Microsoft&#39;s Access, and database products from Oracle, Sybase, and Computer Associates. 
         [0026]    Memory is a further embodiment of the storage as the electronic holding place for instructions and data that the computer&#39;s microprocessor can reach quickly. The memory of the computer can contains the main parts of the operating system and some or all of the application programs (e.g. instructions  302 ) and related data that are being used. Memory can be used as a shorter synonym for random access memory (RAM). This kind of memory is located on one or more microchips that are physically close to the microprocessor in the computer devices  101 . 
         [0027]    Further, it is recognized that the trial sites  18  and the data analysis sites  20  can be configured to communicate with one another and can have configured access to each others storage for interaction with the stored clinical data directly, if desired. For example, the trial ID assigned to a particular data set can also have a data indicator identifying the particular memory address of the respective storage containing the particular data set. Accordingly, any requested updates to the particular data set (e.g. due to inadequate formatting, missing information, etc.) conducted inter- and/or intra-site  18 , 20  can be coordinated. 
         [0028]    Further, it is recognized that the computer devices  101  can contain processors/modules for implementing all steps included in the operations  106 ,  108 ,  110 ,  112 ,  114 ,  116 ,  118 ,  120 . as desired. 
         [0029]    Specifically, the computing device  101  used to implement the data acquisition step  106  by the trial site  18  can include a trial user interface  202  as defined by the respective trial protocol  14   a,b,c,d . The trial user interface  202  would be configured for facilitating operation of coupled imaging devices (not shown) and other devices (not shown) used in data acquisition. The trial user interface  202  provides a standard image layout and set of user functions (that may be restricted and/or simplified by the trial protocol  14   a,b,c,d  provided to the trial site  18 . The use of the trial user interface  202  can facilitate quality control of generating the trial data  22 , through standard operating procedures employed in image acquisition, and consistent pricing information set for use by the trial sites  18 . 
         [0030]    Specifically, the computing device  101  used to implement the trial data  22  review process  114  by the data analysis site  20  can include a quality control processor  208  to help facilitate quality of clinical images and textual data, for example. For this purpose, the quality control processor  208  automatically monitors image quality in the trial data  22 , the degree of compliance with predetermined standards and the degree of compliance with predetermined procedures of the trial protocol  14   a,b,c,d  as it pertains to image content and format. Further, the quality control processor  208 , in response to an automatically determined deficiency of the images of the trial data  22 , can automatically initiate generation of an alert message  122  to the trial site  18  and can automatically initiate preliminary remedial action to correct the determined deficiency. This message  122  can be communicated to the image acquisition  106  device, in order to request a revised set of the trial data  22 . 
         [0031]    Specifically, the computing device  101  used to implement the trial data  22  preparation operation  116  by the data analysis site  20  can include a preparation processor  208  to help facilitate further quality of clinical images and textual data, for example. For this purpose, the preparation control processor  208  facilitate monitoring of image quality of the trial data  22  interactively with a user of the computing device (via the user interface  202 ). The preparation processor  208  can help determine the degree of compliance with predetermined standards and the degree of compliance with predetermined procedures of the trial protocol  14   a,b,c,d  as it pertains to image content and format. The preparation operation  116  is facilitated by the preparation processor  208  (e.g. automatic, manual, or a combination thereof) to perform sanity checks of the trial images, to verify the trial data  22  anonymization, and to otherwise approve the trial data  22  for further processing by the reading operation  118 . The preparation processor  208  can be configured to interact with the user (via the user interface  202 ): to visualize received images (of the trial data  22 ) to verify anonymization correctness (the original images may be downloaded from the trial site  18  for comparison; if no problems have been found the trial data  22  is approved as verified images for the reading  118  operation (e.g. the trial data  22  is then put on the reader&#39;s queue list of trail data  22  to analyze); and if problems have been found the user notifies the remote trial site  18  using a notification message  123  about images or other data that either did not pass the sanity check or that the anonymization was incorrect. This message  123  can be communicated to the image acquisition  106  and/or anonymization device(s), in order to request a revised set of the trial data  22 . 
         [0032]    Further, it is recognized that the communication of the messages  122 , 123  (and others) between the trial site  18  and the data analysis site  20  can be done by respective communication modules (not shown), which would be responsible for transmitting/receiving the messages  122 , 123  between the sites  18 , 20 , as well as distributing and received messages  122 , 123  (or responses thereto) to the respective device within the site  18 , 20 . For example, the trial site communication module could receive a message  123  from the data analysis site communication module, determine from the message  123  contents (with consultation with the trial protocol  14   a  if needed) what corrective steps are required to satisfy the message  123  (e.g. improper anonymization), and then send the message  123  to the appropriate operation (e.g. the anonymization  108  step).