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Title:
DYNAMIC TISSUE SPECIMEN ANALYSIS AND CLINICAL TRIAL MATCHING
Document Type and Number:
WIPO Patent Application WO/2017/172625
Kind Code:
A1
Abstract:
Systems, methods, and computer-readable media are disclosed for dynamic tissue specimen analysis and clinical trial matching. Example methods may include generating a package identifier, associating the package identifier with patient information and instructions, tracking a shipment comprising the package identifier, receiving a request to access the patient information and instructions, determining that the request is authorized, sending the patient information and instructions, receiving metadata associated with scientific analysis of a specimen, and receiving a recommendation for a clinical trial.

Inventors:
DIXON P KENDALL (US)
Application Number:
PCT/US2017/024327
Publication Date:
October 05, 2017
Filing Date:
March 27, 2017
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
B4CC INC (US)
International Classes:
G06Q50/22; G06F19/00; G06Q50/00; G16H10/60
Foreign References:
US20160078196A12016-03-17
US20150228041A12015-08-13
US20070067189A12007-03-22
US20080033658A12008-02-07
US20090089098A12009-04-02
US20080010254A12008-01-10
US20150254432A12015-09-10
Attorney, Agent or Firm:
WARREN, William L. et al. (US)
Download PDF:
Claims:
CLAIMS

WHAT IS CLAIMED IS:

1. A method comprising:

generating, by one or more computer processors coupled to at least one memory, a package identifier;

associating the package identifier with patient information and instructions;

tracking a shipment comprising the package identifier;

receiving a request to access the patient information and instructions;

determining that the request is authorized;

sending the patient information and instructions;

receiving metadata associated with a specimen, wherein the metadata is derived from scientific analysis of the specimen; and

receiving an expert curated and informed recommendation for a clinical trial or other therapy.

2. The method of claim 1, further comprising:

facilitating enrollment of a patient in the clinical trial using the patient information.

3. The method of claim 1, further comprising:

facilitating a payment to a doctor for presentation of the expert curated and informed recommendation.

4. The method of claim 1, further comprising:

storing at least a portion of the specimen for later processing.

5. The method of claim 4, further comprising:

providing a marketplace for the at least the portion of the specimen.

6. The method of claim 1, further comprising:

providing a digital marketplace for vendors of cancer treatments.

7. The method of claim 6, further comprising:

facilitating payment transactions between patients and vendors on the digital marketplace.

8. The method of claim 1, further comprising:

determining a set of available clinical trials; and

matching a patient with one or more of the set of available clinical trials using the patient information.

9. The method of claim 1, further comprising:

matching a patient with a vendor on a digital marketplace based at least in part on the expert curated and informed recommendation.

10. The method of claim 1, wherein the specific analysis is a cancer related analysis.

11. A device comprising:

at least one memory that stores computer-executable instructions; and

at least one processor configured to access the at least one memory and execute the computer-executable instructions to:

generate a package identifier;

associate the package identifier with patient information and instructions; track a shipment comprising the package identifier;

receive a request to access the patient information and instructions;

determine that the request is authorized;

send the patient information and instructions;

receive metadata associated with a specimen, wherein the metadata is derived from scientific analysis of the specimen; and

receive an expert curated and informed recommendation for a clinical trial or other therapy.

12. The device of claim 11, wherein the at least one processor is further configured to access the at least one memory and execute the computer-executable instructions to: facilitate enrollment of a patient in the clinical trial using the patient information.

13. The device of claim 11, wherein the at least one processor is further configured to access the at least one memory and execute the computer-executable instructions to: facilitate a payment to a doctor for presentation of the expert curated and informed recommendation.

14. The device of claim 11, wherein the at least one processor is further configured to access the at least one memory and execute the computer-executable instructions to: monitor storage of at least a portion of the specimen for later processing.

15. The device of claim 14, wherein the at least one processor is further configured to access the at least one memory and execute the computer-executable instructions to: provide a marketplace for the at least the portion of the specimen.

16. The device of claim 11, wherein the at least one processor is further configured to access the at least one memory and execute the computer-executable instructions to: provide a digital marketplace for vendors of cancer treatments.

17. The device of claim 16, wherein the at least one processor is further configured to access the at least one memory and execute the computer-executable instructions to: facilitate payment transactions between patients and vendors on the digital marketplace.

18. The device of claim 11, wherein the at least one processor is further configured to access the at least one memory and execute the computer-executable instructions to: determine a set of available clinical trials; and

match a patient with one or more of the set of available clinical trials using the patient information.

19. The device of claim 11, wherein the at least one processor is further configured to access the at least one memory and execute the computer-executable instructions to: match a patient with a vendor on a digital marketplace based at least in part on the expert curated and informed recommendation.

20. The device of claim 11, wherein the specific analysis is a cancer related analysis.

Description:
DYNAMIC TISSUE SPECIMEN ANALYSIS AND

CLINICAL TRIAL MATCHING

BACKGROUND

[0001] Healthcare professionals, such as oncologists and other doctors, may not be aware of all available healthcare treatments and techniques. As a result, patients of such healthcare professionals may not be treated in an optimal manner, and may similarly be unaware of available treatment options. Certain clinical trials may have an inadequate supply of biological samples or subjects to satisfy research goals. In addition, personalized healthcare may result in improved outcomes for patients; however, healthcare professionals may not engage in personalized healthcare.

BRIEF DESCRIPTION OF THE DRAWINGS

[0002] The detailed description is set forth with reference to the accompanying drawings. The drawings are provided for purposes of illustration only and merely depict example embodiments of the disclosure. The drawings are provided to facilitate understanding of the disclosure and shall not be deemed to limit the breadth, scope, or applicability of the disclosure. In the drawings, the left-most digit(s) of a reference numeral may identify the drawing in which the reference numeral first appears. The use of the same reference numerals indicates similar, but not necessarily the same or identical components. Various embodiments may utilize elements or components other than those illustrated in the drawings, and some elements and/or components may not be present in various embodiments. The use of singular terminology to describe a component or element may, depending on the context, encompass a plural number of such components or elements and vice versa.

[0003] FIG. 1 is a schematic illustration of an example process flow for dynamic tissue specimen analysis and clinical trial matching in accordance with one or more example embodiments of the disclosure.

[0004] FIG. 2 is a schematic illustration of an example system architecture in accordance with one or more example embodiments of the disclosure.

[0005] FIGS. 3-6 are schematic illustrations of example process flows for dynamic tissue specimen analysis and clinical trial matching in accordance with one or more example embodiments of the disclosure. [0006] FIG. 7 is a schematic block diagram of an illustrative voice assistant device in accordance with one or more example embodiments of the disclosure.

DETAILED DESCRIPTION

OVERVIEW

[0007] This disclosure relates to, among other things, devices, systems, methods, computer-readable media, techniques, and methodologies for dynamic tissue specimen analysis and clinical trial matching. Certain embodiments may include automated collaboration across local or national healthcare professional networks. Embodiments of the disclosure may generate metadata for one or more tissue specimens, and match the metadata to ongoing clinical trials, providing patients with potential precision therapy options. Embodiments of the disclosure may be configured to encode or otherwise protect personal health information throughout a research process, and may securely transmit or transport tissue specimens and related data.

[0008] Certain embodiments of the disclosure may provide personalized patient care by matching patients to ongoing clinical trials, thereby providing patients with increased treatment options and providing clinical trials with additional subjects. As a result, patients may engage in the most recent treatment and medicine techniques, while clinical trials may increase their supply of specimens and satisfy their research goals. Embodiments of the disclosure may preserve tissue or biological samples for future research or future personalized healthcare opportunities, and may generate rich data associated with tissue specimens. Such tissue specimens, which may be excess tissue specimens after patient specific processing is complete, may be disassociated with personal health information and may sold to third parties for research or other purposes.

[0009] The systems and methods described herein may provide advanced tumor testing to match and deliver life-saving treatments and trials to patients, and may provide access to data and therapies that may improve patient outcomes. Embodiments of the disclosure may improve patient care and survival metrics (e.g., cancer survival rates, etc.), and may increase a supply of data-rich tumor specimens.

[0010] Referring to FIG. 1, an example process flow 100 for dynamic tissue specimen analysis and clinical trial matching is illustrated in accordance with one or more embodiments of the disclosure. [0011] At block 102 of the process flow 100, a patient diagnosis is generated or received. The patient diagnosis may be generated by a physician in some embodiments and may be received by systems of the disclosure. The patient diagnosis may be followed by a consultation with one or more clinical healthcare specialists, such as an oncologist, surgeon, radiologist, pathologist, or other healthcare provider. The patient may be presented with an opportunity to enroll or otherwise engage in a dynamic tissue specimen analysis and clinical trial matching program. The dynamic tissue specimen analysis and clinical trial matching program may provide the patient with opportunities to enroll in clinical trials that provide care or treatment specific to one or more qualities of the patient (e.g., a patient demographic, body type, etc.).

[0012] At block 104 of the process flow 104, a tumor or tissue sample is extracted from the patient. Upon enrolling in the dynamic tissue specimen analysis and clinical trial matching program, some or all of the patient' s tumor may be extracted.

[0013] At block 106, the tumor or a tissue sample is processed. Processing of the tumor or tissue sample may include laboratory analysis and generation of metadata, including genetic sequence identification, disease identification, and other processing.

[0014] Upon completion of the tumor or tissue sample processing, the process flow 100 may include a number of operations. For example, at block 108, a portion of the tissue sample or tumor (that may be leftover or otherwise unused during the processing) may be sent to a bio bank or other storage location for biological samples. In some instances, the tissue sample may be disassociated from patient-specific data or personal health information. At block 110, scientific analysis may be performed on the tumor or tissue sample. Scientific processing may include the laboratory analysis of block 106 or additional scientific processing. At block 112, another portion of the tissue sample or tumor (that may be leftover or otherwise unused during the processing) may be sent to a third party or may be stored for general research. In some instances, the tissue sample may be disassociated from patient-specific data or personal health information.

[0015] At block 114, the tissue sample or tumor portion sent to the bio bank may be stored and/or later processed for future patient-specific analysis. For example, as new clinical trials start or additional treatment techniques become available, the patient's tissue sample may be used to determine whether the patient is a candidate for a particular study or trial. Future patient specific analysis results may be sent to one or more remote servers. At block 116, the tissue sample or portion sent to the bio bank may be stored or processed for future general research.

[0016] At block 118, the data or results of the immediate tissue sample or tumor processing and scientific analysis of block 110 may be used to identify clinical trials, such as ongoing or soon to begin clinical trials or studies, or other targeted therapies that are specific to the patient. As a result, the patient diagnosed with a disease may be able to receive modern and personalized healthcare and treatment, as the identified clinical trials are based on the patient's own tumor or tissue sample. The identified clinical trials and targeted therapies may be sent to one or more remote servers. In some embodiments, a range of one or more possible matches between the cancer specimen, and related scientific test results thereof, and an assortment of clinical trials, immunotherapies, and various other targeted therapies may be generated. The one or more possible matches may be expertly curated and used to generate an informed report, which may be provided to a bedside care team for a patient.

[0017] At block 120, a patient care conference may be conducted. The patient care conference may include one or more physicians and care team members that discuss the identified clinical trials or targeted therapies and generate recommendations for the patient. The patient care conference may be beneficial in selecting a course of treatment best suited for the individual patient and their personal health history. The results of the conference may be sent to one or more remote servers. One or more participants in the patient care conference may be compensated for participation. In some embodiments, the patient care conference may be triggered by the arrival of the informed report, which may include expert information. The patient care conference may involve a live conversation with one or more experts involved in generating the informed report, or an asynchronous communication on medical matters. The bedside care team may thus be informed and able to proceed with the therapies chosen by their collective wisdom.

[0018] At block 122, the results of the patient care conference may be reported to one or more remote servers. At block 124, a recommended therapy and/or treatment may be provided to the patient. The recommendation may be patient-specific, and may help the patient overcome a disease or increase longevity. Patient progress may be monitored over time once treatment is initiated. [0019] The systems, methods, computer-readable media, techniques, and methodologies for dynamic tissue specimen analysis and clinical trial matching may provide a comprehensive community practice pipeline at reduced costs, and may generate a logistic network with improved efficiency. Patients may be matched with the most effective clinical trial or treatment options based on analysis of patient- specific tumor analysis.

[0020] Example embodiments of the disclosure provide a number of technical features or technical effects. For example, in accordance with example embodiments of the disclosure, cancer patients may be connected with personalized therapies at local community health providers. The above examples of technical features and/or technical effects of example embodiments of the disclosure are merely illustrative and not exhaustive.

[0021] One or more illustrative embodiments of the disclosure have been described above. The above-described embodiments are merely illustrative of the scope of this disclosure and are not intended to be limiting in any way. Accordingly, variations, modifications, and equivalents of embodiments disclosed herein are also within the scope of this disclosure. The above-described embodiments and additional and/or alternative embodiments of the disclosure will be described in detail hereinafter through reference to the accompanying drawings. ILLUSTRATIVE PROCESSES AND USE CASES

[0022] FIG. 2 depicts an example system architecture 200 for dynamic tissue specimen analysis and clinical trial matching in accordance with one or more embodiments of the disclosure. Other embodiments may include different and/or additional or fewer components.

[0023] The system architecture 200 may include one or more B4CC servers 210, one or more tissue specimen data servers 220, one or more user devices 230, and one or more clinical trial data servers 240. One or more of the illustrated components may be in wired or wireless communication via one or more networks 250.

[0024] The B4CC server(s) 210 may be configured to interface with one or more backend servers, such as a bio bank server, a laboratory server, a hospital server, and other servers. The B4CC server(s) 210 may store and/or process patient information and tissue sample data, such as laboratory results, personal health information, and other data. The B4CC server(s) 210 may store shipment data and may manage package identifiers for patient tissue sample shipments. The B4CC server(s) 210 may store clinical trial matches and progress reports for patients, and may be configured to determine one or more clinical trial matches for patients, based at least in part on analysis of tissue samples.

[0025] The tissue specimen data server(s) 220 may be configured to receive, send, and/or generate tissue specimen or tumor data, such as data resulting from scientific analysis of tissue sample. The tissue specimen data server(s) 220 may associate tissue sample data with patient information and may be updated with future general research or future patient specific analysis data.

[0026] The user device(s) 230 may be configured to be used by patients to access one or more components of the system 200 and/or to communicate with one or more parties and view or send information. For example, a user may use the user device(s) 230 to view results of scientific analysis of their tissue specimen, to view or select a clinical trial, to view identified clinical trials, to view a status of tissue sample processing, and for other functions. The user device(s) 230 may be any suitable device, such as a smartphone, a tablet, a laptop computer, or other device.

[0027] The clinical trial data server(s) 240 may be configured to identify one or more available clinical trials and may be periodically or continuously updated with new or upcoming clinical trials and related data, such as requirements for participation. The clinical trial data server(s) 240 may communicate with one or more of the other components to send and receive information. The clinical trial data server(s) 240 may be updated with patient progress when a patient is enrolled in a particular clinical trial.

[0028] FIG. 3 is a schematic illustration of an example process flow 300 for dynamic tissue specimen analysis and clinical trial matching in accordance with one or more example embodiments of the disclosure.

[0029] At block 310 of the process flow 300, a tissue specimen and related data, such as patient information, diagnosis information, location information, and other data, may be received. In one example, the tissue specimen data may be received at the B4CC server(s) of FIG. 2.

[0030] At block 320, a first portion of the tissue specimen is analyzed. Analysis may include a biopsy or other laboratory processing and may be performed by one or more parties. Data from the analysis may be collected and stored. [0031] At block 330, a second portion of the tissue specimen is stored for future analysis. For example, a tissue specimen may be divided into portions, or a leftover tissue sample may be stored after initial scientific analysis is complete. The tissue specimen may be stored at a bio bank or other facility. The stored tissue specimen may be used for future scientific analysis as new clinical trials and treatments become available.

[0032] At block 340, a clinical trial is identified. For example, data from analysis of the tissue specimen may be used to determine whether there is a match with any ongoing or upcoming clinical trial. The data from the analysis may be used, along with the patient information, to determine whether a patient satisfies the criteria to enroll in the clinical trial.

[0033] At block 350, a patient care conference report is received. The patient care conference report may include information related to a conference conducted by a patient care team to discuss the available clinical trials and a recommended course of action. The patient care conference report may be generated by a physician or other party and may be used to memorialize a conference conducted to discuss a patient-specific treatment plan.

[0034] At optional block 360, a recommendation for therapy is sent to the patient. The patient may receive the recommended course of action and may decide whether to enroll in the recommended course of action.

[0035] FIG. 4 is a schematic illustration of an example process flow 300 for dynamic tissue specimen analysis and clinical trial matching in accordance with one or more example embodiments of the disclosure.

[0036] At block 410 of the process flow 400, a specimen collection kit with a package identifier is generated. In one example, the B4CC server(s) of FIG. 2 may generate the package identifier that may be used for tracking a specimen collection kit. The package identifier may be agnostic as to patient information, and may be associated with patient information only accessible to certain parties to protect patient privacy.

[0037] At block 420, the package identifier may be associated with patient information and instructions. For example, the package identifier may be associated with a particular patient and specific instructions as to what specimen is to be collected, etc. The package identifier may only be decoded by certain parties, so as to limit access to patient information. [0038] At block 430, the specimen collection kit may be shipped to a patient's physician. The physician may receive the specimen collection kit and may scan or otherwise attempt to access the patient information and instructions using the package identifier.

[0039] At block 440, a request is received for the patient information and instructions. For example, the physician may scan the package identifier, and as a result, a request for the patient information and instructions may be received by a remote server. The remote server may determine the physician is authorized to view the patient information and instructions.

[0040] At block 450, upon determining the physician is authorized to receive the patient information and instructions, the patient information and instructions may be sent. The physician may receive the patient information and instructions and may collect the specimen. The specimen may be sent to a laboratory for processing. Shipment of the specimen may be tracked by a remote server. The laboratory may receive the specimen and may or may not have access to the patient information. The laboratory may analyze or process the specimen and generate metadata incorporating the results of the analysis or processing. The metadata may be associated with the specimen. The specimen or the leftover of the specimen when analysis is complete may be stored by the laboratory. The metadata generated by the laboratory may be sent to the physician and/or the remote server. For example, at block 460, the lab processing results of the specimen may be received. The physician may receive the metadata and may prepare findings for the patient. In some embodiments, the metadata and related specimen may be added to a marketplace and sold for additional research or other purposes.

[0041] FIG. 5 is a schematic illustration of an example process flow 500 for dynamic tissue specimen analysis and clinical trial matching in accordance with one or more example embodiments of the disclosure. In the process flow 500, a physician may receive a specimen collection kit with a package identifier at block 510. At block 520, the package identifier may be scanned, and at block 530, patient information and instructions may be received. At block 540, a specimen may be collected. The specimen may be collected based at least in part on the instructions. At block 550, the specimen may be sent to a lab.

[0042] FIG. 6 is a schematic illustration of an example process flow 600 for dynamic tissue specimen analysis and clinical trial matching in accordance with one or more example embodiments of the disclosure. At block 610, a laboratory may receive a specimen with a package identifier, and at block 620, the lab may augment or generate metadata associated with the specimen. At optional block 630, the specimen, or a portion thereof, may be stored. At block 640, the metadata may be sent to a physician or one or more remote servers. At block 650, the specimen and related metadata may be added to a marketplace, where research entities may acquire the specimen and metadata.

[0043] One or more operations of the method, process flows, or use cases of FIGS. 1-6 may have been described above as being performed by a user device, or more specifically, by one or more program module(s), applications, or the like executing on a device. It should be appreciated, however, that any of the operations of methods, process flows, or use cases of FIGS. 1-6 may be performed, at least in part, in a distributed manner by one or more other devices, or more specifically, by one or more program module(s), applications, or the like executing on such devices. In addition, it should be appreciated that processing performed in response to execution of computer-executable instructions provided as part of an application, program module, or the like may be interchangeably described herein as being performed by the application or the program module itself or by a device on which the application, program module, or the like is executing. While the operations of the methods, process flows, or use cases of FIGS. 1-6 may be described in the context of the illustrative devices, it should be appreciated that such operations may be implemented in connection with numerous other device configurations.

[0044] The operations described and depicted in the illustrative methods, process flows, and use cases of FIGS. 1-6 may be carried out or performed in any suitable order as desired in various example embodiments of the disclosure. Additionally, in certain example embodiments, at least a portion of the operations may be carried out in parallel. Furthermore, in certain example embodiments, less, more, or different operations than those depicted in FIGS. 1-6 may be performed.

[0045] Although specific embodiments of the disclosure have been described, one of ordinary skill in the art will recognize that numerous other modifications and alternative embodiments are within the scope of the disclosure. For example, any of the functionality and/or processing capabilities described with respect to a particular device or component may be performed by any other device or component. Further, while various illustrative implementations and architectures have been described in accordance with embodiments of the disclosure, one of ordinary skill in the art will appreciate that numerous other modifications to the illustrative implementations and architectures described herein are also within the scope of this disclosure.

[0046] Certain aspects of the disclosure are described above with reference to block and flow diagrams of systems, methods, apparatuses, and/or computer program products according to example embodiments. It will be understood that one or more blocks of the block diagrams and flow diagrams, and combinations of blocks in the block diagrams and the flow diagrams, respectively, may be implemented by execution of computer- executable program instructions. Likewise, some blocks of the block diagrams and flow diagrams may not necessarily need to be performed in the order presented, or may not necessarily need to be performed at all, according to some embodiments. Further, additional components and/or operations beyond those depicted in blocks of the block and/or flow diagrams may be present in certain embodiments.

[0047] Accordingly, blocks of the block diagrams and flow diagrams support combinations of means for performing the specified functions, combinations of elements or steps for performing the specified functions, and program instruction means for performing the specified functions. It will also be understood that each block of the block diagrams and flow diagrams, and combinations of blocks in the block diagrams and flow diagrams, may be implemented by special-purpose, hardware -based computer systems that perform the specified functions, elements or steps, or combinations of special-purpose hardware and computer instructions.

ILLUSTRATIVE DEVICE ARCHITECTURE

[0048] FIG. 7 is a schematic block diagram of an example B4CC server 700 in accordance with one or more example embodiments of the disclosure. The B4CC server 700 may include any suitable computing device capable of receiving and/or generating audio including, but not limited to, a mobile device such as a smartphone, tablet, e-reader, wearable device, or the like; a desktop computer; a laptop computer; a content streaming device; a set-top box; or the like. The B4CC server 700 may correspond to an illustrative device configuration for the voice interaction devices of FIGS. 1-6.

[0049] The B4CC server 700 may be configured to communicate via one or more networks with one or more servers, user devices, or the like. Such network(s) may include, but are not limited to, any one or more different types of communications networks such -l ias, for example, cable networks, public networks (e.g., the Internet), private networks (e.g., frame -relay networks), wireless networks, cellular networks, telephone networks (e.g., a public switched telephone network), or any other suitable private or public packet- switched or circuit-switched networks. Further, such network(s) may have any suitable communication range associated therewith and may include, for example, global networks (e.g., the Internet), metropolitan area networks (MANs), wide area networks (WANs), local area networks (LANs), or personal area networks (PANs). In addition, such network(s) may include communication links and associated networking devices (e.g., link-layer switches, routers, etc.) for transmitting network traffic over any suitable type of medium including, but not limited to, coaxial cable, twisted-pair wire (e.g., twisted-pair copper wire), optical fiber, a hybrid fiber-coaxial (HFC) medium, a microwave medium, a radio frequency communication medium, a satellite communication medium, or any combination thereof.

[0050] In an illustrative configuration, the B4CC server 700 may include one or more processors (processor(s)) 702, one or more memory devices 704 (generically referred to herein as memory 704), one or more input/output ("I/O") interface(s) 706, one or more network interface(s) 708, one or more transceivers 712, and data storage 714. The B4CC server 700 may further include one or more buses 712 that functionally couple various components of the B4CC server 700. The B4CC server 700 may further include one or more antenna(e) 728 that may include, without limitation, a cellular antenna for transmitting or receiving signals to/from a cellular network infrastructure, an antenna for transmitting or receiving Wi-Fi signals to/from an access point (AP), a Global Navigation Satellite System (GNSS) antenna for receiving GNSS signals from a GNSS satellite, a Bluetooth antenna for transmitting or receiving Bluetooth signals, a Near Field Communication (NFC) antenna for transmitting or receiving NFC signals, and so forth. These various components will be described in more detail hereinafter.

[0051] The data storage 714 may include removable storage and/or non-removable storage including, but not limited to, magnetic storage, optical disk storage, and/or tape storage. The data storage 714 may provide non-volatile storage of computer-executable instructions and other data. The memory 704 and the data storage 714, removable and/or non-removable, are examples of computer-readable storage media (CRSM) as that term is used herein. [0052] The data storage 714 may store computer-executable code, instructions, or the like that may be loadable into the memory 704 and executable by the processor(s) 702 to cause the processor(s) 702 to perform or initiate various operations. The data storage 714 may additionally store data that may be copied to memory 704 for use by the processor(s) 702 during the execution of the computer-executable instructions. Moreover, output data generated as a result of execution of the computer-executable instructions by the processor(s) 702 may be stored initially in memory 704, and may ultimately be copied to data storage 714 for non- volatile storage.

[0053] More specifically, the data storage 714 may store one or more operating systems (O/S) 716; one or more database management systems (DBMS) 718; and one or more program module(s), applications, engines, computer-executable code, scripts, or the like such as, for example, one or more clinical trial identification module(s) 720, one or more communication module(s) 722, one or more specimen tracking module(s) 724, and/or one or more patient information module(s) 726. Some or all of these module(s) may be sub-module(s). Any of the components depicted as being stored in data storage 714 may include any combination of software, firmware, and/or hardware. The software and/or firmware may include computer-executable code, instructions, or the like that may be loaded into the memory 704 for execution by one or more of the processor(s) 702. Any of the components depicted as being stored in data storage 714 may support functionality described in reference to correspondingly named components earlier in this disclosure.

[0054] The processor(s) 702 may be configured to access the memory 704 and execute computer-executable instructions loaded therein. For example, the processor(s) 702 may be configured to execute computer-executable instructions of the various program module(s), applications, engines, or the like of the B4CC server 700 to cause or facilitate various operations to be performed in accordance with one or more embodiments of the disclosure. The processor(s) 702 may include any suitable processing unit capable of accepting data as input, processing the input data in accordance with stored computer- executable instructions, and generating output data. The processor(s) 702 may include any type of suitable processing unit including, but not limited to, a central processing unit, a microprocessor, a Reduced Instruction Set Computer (RISC) microprocessor, a Complex Instruction Set Computer (CISC) microprocessor, a microcontroller, an Application Specific Integrated Circuit (ASIC), a Field-Programmable Gate Array (FPGA), a System- on-a-Chip (SoC), a digital signal processor (DSP), and so forth. Further, the processor(s) 702 may have any suitable microarchitecture design that includes any number of constituent components such as, for example, registers, multiplexers, arithmetic logic units, cache controllers for controlling read/write operations to cache memory, branch predictors, or the like. The microarchitecture design of the processor(s) 702 may be capable of supporting any of a variety of instruction sets.

[0055] Referring now to functionality supported by the various program module(s) depicted in FIG. 7, the clinical trial identification module(s) 720 may include computer- executable instructions, code, or the like that responsive to execution by one or more of the processor(s) 702 may perform functions including, but not limited to, aggregating available clinical trial data, including participation criteria, timelines, locations, personnel, and other data, and matching patients to available clinical trials.

[0056] The communication module(s) 722 may include computer-executable instructions, code, or the like that responsive to execution by one or more of the processor(s) 702 may perform functions including, but not limited to, communicating with one or more devices, for example, via wired or wireless communication.

[0057] The specimen tracking module(s) 724 may include computer-executable instructions, code, or the like that responsive to execution by one or more of the processor(s) 702 may perform functions including, but not limited to, generating package identifier and tracking specimen shipments and location, encoding package data and de- identifying specimens during transit.

[0058] The patient information module(s) 726 may include computer-executable instructions, code, or the like that responsive to execution by one or more of the processor(s) 702 may perform functions including, but not limited to, collecting or determining patient information and determining patient progress and matches.

[0059] Referring now to other illustrative components depicted as being stored in the data storage 714, the O/S 716 may be loaded from the data storage 714 into the memory 704 and may provide an interface between other application software executing on the B4CC server 700 and hardware resources of the B4CC server 700. More specifically, the O/S 716 may include a set of computer-executable instructions for managing hardware resources of the B4CC server 700 and for providing common services to other application programs (e.g., managing memory allocation among various application programs). In certain example embodiments, the O/S 716 may control execution of the other program module(s) to dynamically enhance characters for content rendering. The O/S 716 may include any operating system now known or which may be developed in the future including, but not limited to, any server operating system, any mainframe operating system, or any other proprietary or non-proprietary operating system.

[0060] The DBMS 718 may be loaded into the memory 704 and may support functionality for accessing, retrieving, storing, and/or manipulating data stored in the memory 704 and/or data stored in the data storage 714. The DBMS 718 may use any of a variety of database models (e.g., relational model, object model, etc.) and may support any of a variety of query languages. The DBMS 718 may access data represented in one or more data schemas and stored in any suitable data repository including, but not limited to, databases (e.g., relational, object-oriented, etc.), file systems, flat files, distributed datastores in which data is stored on more than one node of a computer network, peer-to- peer network datastores, or the like. In those example embodiments in which the B4CC server 700 is a mobile device, the DBMS 718 may be any suitable light-weight DBMS optimized for performance on a mobile device.

[0061] It should be appreciated that the program module(s), applications, computer- executable instructions, code, or the like depicted in FIG. 7 as being stored in the data storage 714 are merely illustrative and not exhaustive and that processing described as being supported by any particular module may alternatively be distributed across multiple module(s) or performed by a different module. In addition, various program module(s), script(s), plug-in(s), Application Programming Interface(s) (API(s)), or any other suitable computer-executable code hosted locally on the B4CC server 700, and/or hosted on other computing device(s) accessible via one or more networks, may be provided to support functionality provided by the program module(s), applications, or computer-executable code depicted in FIG. 5 and/or additional or alternate functionality. Further, functionality may be modularized differently such that processing described as being supported collectively by the collection of program module(s) depicted in FIG. 5 may be performed by a fewer or greater number of module(s), or functionality described as being supported by any particular module may be supported, at least in part, by another module. In addition, program module(s) that support the functionality described herein may form part of one or more applications executable across any number of systems or devices in accordance with any suitable computing model such as, for example, a client-server model, a peer-to-peer model, and so forth. In addition, any of the functionality described as being supported by any of the program module(s) depicted in FIG. 5 may be implemented, at least partially, in hardware and/or firmware across any number of devices.

[0062] It should further be appreciated that the B4CC server 700 may include alternate and/or additional hardware, software, or firmware components beyond those described or depicted without departing from the scope of the disclosure. More particularly, it should be appreciated that software, firmware, or hardware components depicted as forming part of the B4CC server 700 are merely illustrative and that some components may not be present or additional components may be provided in various embodiments. While various illustrative program module(s) have been depicted and described as software module(s) stored in data storage 714, it should be appreciated that functionality described as being supported by the program module(s) may be enabled by any combination of hardware, software, and/or firmware. It should further be appreciated that each of the above - mentioned module(s) may, in various embodiments, represent a logical partitioning of supported functionality. This logical partitioning is depicted for ease of explanation of the functionality and may not be representative of the structure of software, hardware, and/or firmware for implementing the functionality. Accordingly, it should be appreciated that functionality described as being provided by a particular module may, in various embodiments, be provided at least in part by one or more other module(s). Further, one or more depicted module(s) may not be present in certain embodiments, while in other embodiments, additional module(s) not depicted may be present and may support at least a portion of the described functionality and/or additional functionality. Moreover, while certain module(s) may be depicted and described as sub-module(s) of another module, in certain embodiments, such module(s) may be provided as independent module(s) or as sub-module(s) of other module(s).

[0063] One or more operations of the methods, process flows, and use cases of FIGS. 1-6 may be performed by a device having the illustrative configuration depicted in FIG. 7, or more specifically, by one or more engines, program module(s), applications, or the like executable on such a device. It should be appreciated, however, that such operations may be implemented in connection with numerous other device configurations. [0064] The operations described and depicted in the illustrative methods and process flows of FIGS. 1-6 may be carried out or performed in any suitable order as desired in various example embodiments of the disclosure. Additionally, in certain example embodiments, at least a portion of the operations may be carried out in parallel. Furthermore, in certain example embodiments, less, more, or different operations than those depicted in FIGS. 1-6 may be performed.

[0065] Although specific embodiments of the disclosure have been described, one of ordinary skill in the art will recognize that numerous other modifications and alternative embodiments are within the scope of the disclosure. For example, any of the functionality and/or processing capabilities described with respect to a particular device or component may be performed by any other device or component. Further, while various illustrative implementations and architectures have been described in accordance with embodiments of the disclosure, one of ordinary skill in the art will appreciate that numerous other modifications to the illustrative implementations and architectures described herein are also within the scope of this disclosure.

[0066] Certain aspects of the disclosure are described above with reference to block and flow diagrams of systems, methods, apparatuses, and/or computer program products according to example embodiments. It will be understood that one or more blocks of the block diagrams and flow diagrams, and combinations of blocks in the block diagrams and the flow diagrams, respectively, may be implemented by execution of computer- executable program instructions. Likewise, some blocks of the block diagrams and flow diagrams may not necessarily need to be performed in the order presented, or may not necessarily need to be performed at all, according to some embodiments. Further, additional components and/or operations beyond those depicted in blocks of the block and/or flow diagrams may be present in certain embodiments.

[0067] Accordingly, blocks of the block diagrams and flow diagrams support combinations of means for performing the specified functions, combinations of elements or steps for performing the specified functions, and program instruction means for performing the specified functions. It will also be understood that each block of the block diagrams and flow diagrams, and combinations of blocks in the block diagrams and flow diagrams, may be implemented by special-purpose, hardware -based computer systems that perform the specified functions, elements or steps, or combinations of special-purpose hardware and computer instructions.

[0068] Program module(s), applications, or the like disclosed herein may include one or more software components including, for example, software objects, methods, data structures, or the like. Each such software component may include computer-executable instructions that, responsive to execution, cause at least a portion of the functionality described herein (e.g., one or more operations of the illustrative methods described herein) to be performed.

[0069] A software component may be coded in any of a variety of programming languages. An illustrative programming language may be a lower- level programming language such as an assembly language associated with a particular hardware architecture and/or operating system platform. A software component comprising assembly language instructions may require conversion into executable machine code by an assembler prior to execution by the hardware architecture and/or platform.

[0070] Another example programming language may be a higher-level programming language that may be portable across multiple architectures. A software component comprising higher-level programming language instructions may require conversion to an intermediate representation by an interpreter or a compiler prior to execution.

[0071] Other examples of programming languages include, but are not limited to, a macro language, a shell or command language, a job control language, a script language, a database query or search language, or a report writing language. In one or more example embodiments, a software component comprising instructions in one of the foregoing examples of programming languages may be executed directly by an operating system or other software component without having to be first transformed into another form.

[0072] A software component may be stored as a file or other data storage construct. Software components of a similar type or functionally related may be stored together such as, for example, in a particular directory, folder, or library. Software components may be static (e.g., pre-established or fixed) or dynamic (e.g., created or modified at the time of execution).

[0073] Software components may invoke or be invoked by other software components through any of a wide variety of mechanisms. Invoked or invoking software components may comprise other custom-developed application software, operating system functionality (e.g., device drivers, data storage (e.g., file management) routines, other common routines and services, etc.), or third-party software components (e.g., middleware, encryption, or other security software, database management software, file transfer or other network communication software, mathematical or statistical software, image processing software, and format translation software).

[0074] Software components associated with a particular solution or system may reside and be executed on a single platform or may be distributed across multiple platforms. The multiple platforms may be associated with more than one hardware vendor, underlying chip technology, or operating system. Furthermore, software components associated with a particular solution or system may be initially written in one or more programming languages, but may invoke software components written in another programming language.

[0075] Computer-executable program instructions may be loaded onto a special- purpose computer or other particular machine, a processor, or other programmable data processing apparatus to produce a particular machine, such that execution of the instructions on the computer, processor, or other programmable data processing apparatus causes one or more functions or operations specified in the flow diagrams to be performed. These computer program instructions may also be stored in a computer-readable storage medium (CRSM) that upon execution may direct a computer or other programmable data processing apparatus to function in a particular manner, such that the instructions stored in the computer-readable storage medium produce an article of manufacture including instruction means that implement one or more functions or operations specified in the flow diagrams. The computer program instructions may also be loaded onto a computer or other programmable data processing apparatus to cause a series of operational elements or steps to be performed on the computer or other programmable apparatus to produce a computer- implemented process.

[0076] Additional types of CRSM that may be present in any of the devices described herein may include, but are not limited to, programmable random access memory (PRAM), SRAM, DRAM, RAM, ROM, electrically erasable programmable read-only memory (EEPROM), flash memory or other memory technology, compact disc read-only memory (CD-ROM), digital versatile disc (DVD) or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to store the information and which can be accessed. Combinations of any of the above are also included within the scope of CRSM. Alternatively, computer-readable communication media (CRCM) may include computer- readable instructions, program module(s), or other data transmitted within a data signal, such as a carrier wave, or other transmission. However, as used herein, CRSM does not include CRCM.

[0077] Although embodiments have been described in language specific to structural features and/or methodological acts, it is to be understood that the disclosure is not necessarily limited to the specific features or acts described. Rather, the specific features and acts are disclosed as illustrative forms of implementing the embodiments. Conditional language, such as, among others, "can," "could," "might," or "may," unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments could include, while other embodiments do not include, certain features, elements, and/or steps. Thus, such conditional language is not generally intended to imply that features, elements, and/or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without user input or prompting, whether these features, elements, and/or steps are included or are to be performed in any particular embodiment.