WO2012093163A2 - Display of clinical research data using an avatar - Google Patents

Display of clinical research data using an avatar Download PDF

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Publication number
WO2012093163A2
WO2012093163A2 PCT/EP2012/050160 EP2012050160W WO2012093163A2 WO 2012093163 A2 WO2012093163 A2 WO 2012093163A2 EP 2012050160 W EP2012050160 W EP 2012050160W WO 2012093163 A2 WO2012093163 A2 WO 2012093163A2
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WO
WIPO (PCT)
Prior art keywords
subjects
clinical research
visual indicator
research data
data
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PCT/EP2012/050160
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French (fr)
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WO2012093163A3 (en
Inventor
John VARAKLIS
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Novartis Ag
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Publication date
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Publication of WO2012093163A2 publication Critical patent/WO2012093163A2/en
Publication of WO2012093163A3 publication Critical patent/WO2012093163A3/en

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Classifications

    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H15/00ICT specially adapted for medical reports, e.g. generation or transmission thereof
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/20ICT specially adapted for the handling or processing of patient-related medical or healthcare data for electronic clinical trials or questionnaires

Definitions

  • the present application relates generally to the display of medical data, and more particularly, to the organization and display of clinical research data using an avatar.
  • Drug manufacturers generally perform clinical trials to determine the safety and efficacy of a new medical treatment, for example, a new drug.
  • the medical treatment is administered to subjects in a test group. These subjects are monitored to gather clinical research data associated with subjects before, during, and after administration of the medical treatment. Based on an analysis of the data collected from the test group, a determination can be made on whether or not the treatment is safe, effective, and suitable for sale to the general public.
  • This approach further extends to the post-marketing phase of treatment, where real-world use data is also collected for a number of safety, efficacy, and cost-effectiveness use cases.
  • clinical research data associated with a plurality of subjects may be displayed within interfaces having an avatar representation of the plurality of subjects.
  • a set of clinical data associated with the subjects is received.
  • the avatar representation of the subjects is displayed.
  • a visual indicator at a location associated with an anatomical component of the avatar representation is displayed. The visual indicator represents at least a portion of the set of clinical research data
  • the location on which the visual indicator is displayed is determined based at least in part on the portion of the set of clinical research data.
  • FIG. 1 illustrates an exemplary interface including an avatar representation for displaying medical data for a set of subjects.
  • FIG. 2 illustrates another portion of the exemplary interface as depicted in FIG. 1, including an avatar representation.
  • FIG. 3 illustrates another exemplary interface comprising an avatar representation.
  • FIG. 4 illustrates an exemplary process, in block diagrammatic form, for displaying medical data for a set of subjects.
  • FIG. 5 illustrates an exemplary computing system, in block diagrammatic form, that may be used to implement some or all processing functionality of various embodiments herein.
  • the interfaces may include an avatar for displaying a set of medical data, including clinical research data, associated with a set of subjects.
  • Visual representations of at least a portion of the set of medical data may be displayed with the avatar on or near a portion of the avatar associated with the at least a portion of the set of medical data.
  • the medical data to be displayed with the avatar may be filtered based at least in part on user selections made within the interface.
  • the filters may be objective, subjective, or both.
  • the filters may include subjects, symptoms, severity, medication use, medication compliance, concomitant medication use, existing medical history, diet, laboratory data, quality of life and similar questionnaires, anatomical components, dates, times, representation of motion over time, images, genetic data, drug (or treatment) type, drug (or treatment) response, and the like.
  • the interfaces may be used by a patient, subject of a clinical trial, physician, health-care provider, researcher, etc. Additionally, access management functions may be provided to provide different levels of access to different users. For example, a physician may be provided with complete access, such as using one access permission setting, while a researcher may be provided more limited access, such as using another access permission setting.
  • FIG. 1 illustrates an exemplary interface 100 for displaying medical data associated with a set of subjects.
  • the medical data may include any psychological or physiological data associated with the subjects.
  • the medical data may further include full or partial medical history data associated with the subjects.
  • the set of subjects may comprise a test group in a clinical trial.
  • the medical data may include clinical research data related to clinical trials used to test drugs, treatments, prevention of diseases, radiation therapy, surgical strategies, and the like. Additionally, the medical data may include subject identifications and symptoms, measurements, treatments, and the like, associated with each of the subjects.
  • interface 100 may be used to display any type of medical data associated with any set of subjects comprising any type of organism (e.g., humans, animals, plants, cells, and the like). Although certain embodiments are described below in connection with displaying clinical research data, it should be recognized that these embodiments can be used in connection with displaying medical or health records of patients.
  • organism e.g., humans, animals, plants, cells, and the like.
  • Interface 100 may include an avatar portion 101 for displaying a visual representation of the medical data overlaid on avatar 103.
  • the medical data may be associated with any type of organism (e.g., human, simian, dog, cat, and the like)
  • avatar 103 may take a form representative of the subjects associated with the medical data being displayed using interface 100.
  • the appearance of avatar 103 may or may not correlate exactly with the organism being represented.
  • a graphical representation of a typical dog may be used to display medical data associated with dogs of varying breeds, sizes, and other physical characteristics.
  • avatar 103 may be gender neutral or gender specific, and may be generally or anatomically correct to reflect girth and height differences.
  • a gender neutral graphical representation of a human may be used for clinical research data that include subjects of both male and female genders.
  • a gender specific avatar of a male may be used for representing medical data that is specific to males.
  • FIG. 3 depicts avatar 103 as a female.
  • avatar 103 may comprise a two-dimensional (2-D) or three-dimensional (3-D) (inclusive or exclusive of a time dimension component) representation of the set of subjects.
  • side-by-side presentations of multiple sets of subject may be provided.
  • one set of subjects can depict a baseline or placebo set for comparison.
  • multiple sets can each depict different therapies, such as different drugs, different dosages of the same drug, or different routes of administration of the same or different drugs.
  • avatar 103 may be displayed using varying levels of detail. For instance, in some examples, avatar 103 may be displayed as a skin-coated model that shows no inner components of the avatar. In other examples, avatar 103 may show the inner components of the avatar, such as the bones, muscles, organs, veins, arteries, cells, pathways, and the like. In some embodiments, interface 100 may include options to allow the user to selectively adjust the components displayed with avatar 103. For example, FIG. 1 depicts avatar 103 with certain major organs (e.g., brain, lungs, stomach, intestines, etc.) displayed. FIG. 2 depicts avatar 103 with additional components (e.g., bones, blood vessels, etc.) displayed.
  • major organs e.g., brain, lungs, stomach, intestines, etc.
  • additional components e.g., bones, blood vessels, etc.
  • the user can switch between the less detailed view in FIG. 1 to the more detailed view in FIG. 2 by an appropriate switch, such as a software or hardware implemented switch.
  • an appropriate switch such as a software or hardware implemented switch.
  • the user may select the "Anatomy" button to switch views.
  • specific physiological and/or anatomical systems, subsystems or components may be selected for viewing using checkboxes, as an exemplary user interface, associated with the specific components.
  • specific views may comprise the circulatory system, lymphatic system, muscle system, skeletal system, nervous system, skin, bones, muscles, organs, veins, arteries, cells, pathways, combinations thereof and selections thereof.
  • a user may be allowed to manipulate avatar 103 using features such as zoom-in, zoom-out, scroll, pan, or rotate. Also, a user can move from summary infonnation to detailed information, that is, can drill down into greater levels of detail, and vice versa. These features can be incorporated with the access management functions described above. For example, only users with the necessary access permission setting may be permitted to drill down below a specific level of detail.
  • Avatar portion 101 may further include one or more visual indicators 105 for visually representing at least a portion of the medical data associated with one or more subjects from the set of subjects.
  • visual indicator 105 can include a pointer portion 104 and a caption portion 106.
  • using visual indicator 105 in conjunction with avatar 103 provides a user with a visual representation of the medical data that allows a user to more easily analyze the data than by using a strictly textual display of the medical data.
  • Indicators 105 may also be used to associate audio and video and the like to represent data, such as pulse, heartbeat, dosing events, etc.
  • Visual indicator 105 may represent data associated with a single subject from the set of subjects or may represent data associated with multiple subjects from the set of subjects. Similarly, visual indicator 105 may represent a single medical condition (e.g., head injury, stomach pain, a disease, and the like) or may represent multiple medical conditions. In one embodiment, a series of avatars 103 may be plotted against an axis, such as time, to illustrate a change over time, such as a change in pain or symptom.
  • a single medical condition e.g., head injury, stomach pain, a disease, and the like
  • a series of avatars 103 may be plotted against an axis, such as time, to illustrate a change over time, such as a change in pain or symptom.
  • Visual indicator 105 may be positioned on or near an anatomical component of a subject (e.g., head, arm, leg, etc.) associated with the medical data being displayed.
  • a subject e.g., head, arm, leg, etc.
  • pointer portion 104 of a visual indicator 105 which represents data associated with headaches, is positioned on the brain of avatar 103.
  • visual indicator 105 represent data associated with conditions that are not associated with a particular anatomical component.
  • FIG. 1 depicts visual indicators 105 representing data associated with conditions for
  • Visual indicator 105 may be used to represent any type of subject-associated, and/or medical data.
  • visual indicator 105 may be used to represent the total number of subjects from the set of subjects experiencing a particular condition, the fraction of total subjects experiencing a condition associated with a particular body part, severity of pain, type of pain, drag or treatment response, and the like.
  • Environmental, historical and/or metadata may also be represented by an indicator 105.
  • Visual indicator 105 may comprise symbols (static and dynamic), change in intensity over time, numerical representations (e.g., total counts, fractions, and the like), color representations (e.g., colors associated with numerical values or symptoms), patterns (e.g., shading or textures), and tactile (haptic) capability where possible, or combinations thereof.
  • visual indicator 105 may include a percentage value that identifies the percentage of subjects in the set of subjects that experienced a specific medical condition.
  • the indicator may be an integer representing the number of subjects that experienced the specific medical condition during a clinical trial.
  • the indicator may comprise text, such as "HEADACHE,” to indicate that at least one subject experienced headaches.
  • the indicator may also include an integer identifying the number of subjects experiencing the headaches.
  • visual indicator 105 may include a fraction comprising a numerator representing the number of subjects experiencing a specific medical condition and a denominator representing the total number of subjects in the set of subjects.
  • the fraction may or may not be written in lowest terms (e.g., by dividing the numerator and the denominator by their greatest common divisor).
  • the fraction "1/10” may indicate that for every ten subjects, conditions, events, and the like represented by the medical data experienced a specific medical condition.
  • Using a visual indicator having a fraction positioned on or near an associated anatomical component of the avatar provides a user of interface 100 with information relating to the probability that a particular condition occurs. This may be used, for example, to identify correlations between the treatment being studied and potential side-effects.
  • Such fraction may be additionally or alternatively expressed as a percentage or as a pictorial presentation, color, intensity, or sound.
  • the color or intensity of visual indicator 105 may be varied to convey information about the medical data.
  • the color or intensity may be based on the medical condition, the number of subjects in the clinical trial, the number of subjects experiencing the medical condition, the percentage of subjects experiencing the medical condition, the anatomical component associated with the medical data, the severity of the medical condition, or any combination thereof with respect to a color mapping scheme.
  • the selected values of the medical data may be mapped to a hue ranging from 0 to 120.
  • the values of 0 and 120 may represent red and green, respectively, as in the cylindrical coordinate color representation known in the art as hue, saturation, and lightness (“HSL”) and hue, saturation, and value (“HSV”) cylindrical- coordinate representations.
  • the indicator may be green if no subjects experienced a particular condition, yellow if half the subjects experienced the condition, red if all of the subjects experienced the condition, and combinations of these colors for intermediate values of subjects experiencing the condition.
  • This color mapping scheme is only provided as an example, as other color mapping schemes may also be used.
  • appropriate grey-scale representations (with or without gamma corrections) may also be used, as may any non-color depiction known to the art, such as hatching, cross- hatching, lines, shading and symbols.
  • a flag may be used in place of the color or intensity.
  • mapping schemes such as heat maps, contour maps, cluster maps, fractal maps and the like may be employed.
  • pointer portion 104 of visual indicator 105 may be used to represent aspects of a condition in addition to identifying the relevant anatomical component of avatar 103.
  • various symbols are used to indicate various severities and corresponding actions taken related to conditions for headaches, mouth ulcers, common colds, vomiting, and constipation.
  • the symbol associated with the conditions for headaches, common cold, vomiting, and constipation indicates an adverse event with no further action taken.
  • the symbol associated with the condition for mouth ulcers indicates a condition that caused the subject to discontinue from the trial.
  • the symbol associated with the condition for nausea indicates a change in dosing or change in concomitant medications that the event caused or required.
  • visual indicator 105 may be an icon for an anatomical component, such as an organ or cell, of avatar 103.
  • visual indicator 105 may be an icon depicting the heart.
  • the color of visual indicator 105 can be varied to convey information about the medical conditions of the anatomical component (in this example, hearts of the subjects).
  • visual indicator 105 can be animated (with and without sound components) to convey information about the medical conditions of the anatomical component.
  • visual indicator 105 can be animated to pulse to convey information, such as average heart rate of subjects. It should be recognized that various types of animation can be associated with various types of information.
  • pulsing of arteries can depict hypertension
  • throbbing of the brain can depict headaches
  • pulsation of the stomach can depict nausea, and the like.
  • Other modes of animation may be used, alternatively or additionally, include blinking, expanding, contracting, fade-in, fade-out, and the like.
  • visual indicator 105 may be associated with haptic technology to provide tactile feedback to the user.
  • vibrations can be applied to the user, such as the user's fingertip. In such case, vibration can be modulated to convey information.
  • auditory feedback that is, sound
  • visual indicator 105 can additionally be associated with visual indicator 105, or sound may be used as an alternative thereto.
  • a heartbeat sound can be associated with the icon.
  • sound can be modulated, such as in phase or intensity, or both, to convey information.
  • additional information may be presented to a user in response to the user selecting or indicating interest in an anatomical component of avatar 103 or a visual indicator 105.
  • a user may be presented with a list of subjects that experienced a medical condition related to the elbow in response to the user selecting an elbow of avatar 103.
  • a user may be presented with medical data, such as x-rays or lab results, relating to visual indicator 105 in response to the user selecting the indicator.
  • the medical data represented by visual indicator 105 may be filtered based on a variety of categories, such as subject, symptom, time, and the like.
  • Interface 100 may include displays representing some or all of the filter categories.
  • FIG. 1 illustrates portions 107, 111, and 115 representing categories that may be used to filter the medical data displayed in avatar portion 101. Portions 107, 111, and 115 are described below with respect to specific filter categories. However, it should be appreciated that the specific categories displayed in interface 100 may be varied depending on the preference of the user and that any combination of categories may be used. Additionally, any number of filter categories may be included in interface 100.
  • interface 100 may include subject portion 107 for displaying a list of one or more subjects 109 from the set of subjects.
  • List of one or more subjects 109 may comprise text (e.g., the subject's name), images (such as the subject's face), numerical identifiers, phenotypic information (e.g., blue eyes, height, etc.), genomic information, historical medical or environmental information (such as past injuries), combinations thereof, or selections thereof.
  • subjects may be added, removed, selected, or unselected, within subject portion 107. Subjects may be added to or removed from subject portion 107 to include or exclude, respectively, those subjects from the set of subjects.
  • subjects may be selected or unselected to display, hide, or not display, respectively, medical data associated with those subjects in avatar portion 101.
  • a user may selectively include data associated with a subset of subjects (e.g., all male subjects) from the set of subjects by highlighting, or otherwise selecting, all the male subjects from subject portion 107. This may be used, for example, to identify correlations between a subset of subjects (e.g., males) and a particular side- effect.
  • Exemplary interface 100 may further include symptom portion 111 for displaying a list of one or more symptoms 113.
  • List of one or more symptoms 113 may include a list of all known symptoms or a subset of all known symptoms. For example, list of one or more symptoms 113 may only include those symptoms experienced by subjects in the set of subjects. Alternatively, list of one or more symptoms 113 may include all possible symptoms that may be experienced by the subjects.
  • symptoms may be selected or unselected to display or not display, respectively, medical data associated with those symptoms in avatar portion 101.
  • a user may selectively include data associated with a subset of symptoms (e.g., mouth ulcer) from the set of symptoms by highlighting, or otherwise selecting, "mouth ulcer" from symptom portion 111. Additionally, in some subset of symptoms (e.g., mouth ulcer) from the set of symptoms by highlighting, or otherwise selecting, "mouth ulcer" from symptom portion 111. Additionally, in some subset of symptoms (e.g., mouth ulcer) from the set of symptoms by highlighting, or otherwise selecting,
  • counts of subjects experiencing each of the symptoms in list of one or more symptoms 113 may be included within symptom portion 111.
  • Exemplary interface 100 may further include time portion 115 for displaying time data associated with the medical data.
  • Time data may include data such as time a drug or treatment was administered, time a symptom and/or a condition was observed, time (e.g., time of a patient activity, such as eating, sleeping, moving, exercising, etc.), changes in morphology, changes in activity, changes in biochemical parameters, changes in cognitive behavior, changes in coordination and visual acuity, and the like.
  • Time data may be displayed sequentially in a list, or may be displayed graphically (as depicted in FIG. 1), as on a timeline, or as a video over time.
  • Time portion 115 data may comprise time (hours, minutes, seconds or smaller divisions), calendar data such as day of the week, month and/or year, or combinations thereof. Time portion 115 data may be based upon an absolute standard (such as UTC time) and may identify a starting and ending day, month, and year. The time data and/or range may also be a relative time range, such as the prior (relative to a time zero or a pre-selected start time/date) week, past month, or the first two years of the clinical trial, for example. This may be advantageous for understanding clinical research data during a specific duration of the clinical trial.
  • times or ranges of time may be selected to display medical data associated with those times in avatar portion 101.
  • a user may selectively include data associated with a subset of time (e.g., between January 2010 and March 2010) by entering start and end times, or otherwise selecting a desired time range from time portion 115.
  • interface 100 allows a user to filter the medical data according to any or all categories represented by portions 107, 111, and 115. For example, a user may filter the medical data displayed in avatar portion 101 to include only male subjects by making the appropriate selections in subject portion 107.
  • the user may optionally further filter the data by displaying only male subjects experiencing head pain by further highlighting, or otherwise selecting, "mouth ulcer” from the list of symptoms in symptom portion 111.
  • a user may optionally further filter the data by displaying only male subjects experiencing head pain observed in the past 3 months by further highlighting, or otherwise selecting, a range of time including the last 3 months from time portion 115.
  • interface 100 may be used to track drug dosing events and to monitor the effects that the drug has on one or more subjects.
  • oral dosage forms such as pills
  • circuitry for identifying an ingestion event and communicating the occurrence of the ingestion event such as by uplink to an external monitor/receiver/transmitter/recorder
  • These pills may be administered to a plurality of subjects identified in subject portion 107 of interface 100.
  • the time of the ingestion event may be recorded and displayed within time portion 115. This can also extend to a variety of other drug delivery modalities, such as inhalation, injection, infusion, transdermal, and the like.
  • data from the ingestion of one or more drug dosing events may be transmitted automatically or semi-automatically to interface 100, or may be entered manually. Additionally, the subject may be monitored for symptoms listed in symptom portion 111. Using the data displayed in interface 100, a user may identify correlations between the drug dosing events and symptoms of conditions experienced by the subjects. In another example, the corresponding pharmacokinetic and/or pharmacodynamic properties of dosing events may be represented on interface 100, and the capabilities provided by avatar 103 can permit the user to zoom in or out of levels of anatomical, cellular or pathway of interest using the capabilities provided by avatar 103.
  • interface 100 may be used to display information obtained using biomarkers. For example, measurements associated with a biomarker can be displayed to the user by associating the measurements with the appropriate anatomical component of avatar 103.
  • FIG. 4 illustrates an exemplary process 400 for displaying medical data associated with a set of subjects.
  • a set of medical data comprising medical data associated with each of a plurality of subjects is received or accessed.
  • the medical data of the set of medical data may be associated with an anatomical component of a subject.
  • an avatar representation of the plurality of subjects may be displayed.
  • the avatar representation of the plurality of subjects may be similar or identical to avatar 103 of FIG. 1.
  • a visual indicator may be displayed at a location associated with an anatomical component of the avatar representation of the plurality of subjects.
  • the visual indicator may represent at least a portion of the set of medical data.
  • the location of the visual indicator may be determined based at least in part on the at least a portion of the set of medical data.
  • the visual indicator may be similar or identical to visual indicator 105 of FIG. 1.
  • the at least a portion of the set of medical data may be selected based on one or more filters selected by a user.
  • the filters may be objective, subjective, or both.
  • the filters may include subjects, symptoms, severity, medication compliance, concomitant medication use, existing medical history, diet, laboratory data, quality of life and similar questionnaires, anatomical components, dates, representation of motion over time, images, genetic data, drug (or treatment) type, drug (or treatment) response, and the like. While the functions performed in process 400 were described in a particular order, it should be appreciated that the functions performed may be performed in any order.
  • FIG. 5 illustrates an exemplary computing system 500 that may be employed to implement processing functionality for various aspects of the current technology (e.g., as a user/client device, media server, media capture server, media rules server, rules store, media asset library, activity data logic/database, combinations thereof, and the like).
  • Computing system 500 may represent, for example, a user device such as a medicament (medication) dispensing device, desktop, mobile phone, personal entertainment device, cameras, microphones, DVR, and so on, a mainframe, server, or any other type of special or general purpose computing device as may be desirable or appropriate for a given application or environment.
  • Computing system 500 includes a human detectable interface to display the medical, avatar, or other information in visual, auditory or tactile form.
  • the interface comprises a visual display monitor (not shown).
  • Computing system 500 can include one or more processors, such as a processor 504.
  • Processor 504 can be implemented using a general or special purpose processing engine such as, for example, a microprocessor, microcontroller or other control logic.
  • processor 504 is connected to a bus 502 or other communication medium.
  • Computing system 500 can also include a main memory 508, such as random access memory (RAM) or other dynamic memory, for storing information and instructions to be executed by processor 504.
  • Main memory 508 also may be used for storing temporary variables or other intermediate information during execution of instructions to be executed by processor 504.
  • Computing system 500 may likewise include a read only memory (“ROM”) or other static storage device coupled to bus 502 for storing static information and instructions for processor 504.
  • ROM read only memory
  • the computing system 500 may also include information storage mechanism 510, which may include, for example, a media drive 512 and a removable storage interface 520.
  • the media drive 512 may include a drive or other mechanism to support fixed or removable storage media, such as a hard disk drive, a floppy disk drive, a magnetic tape drive, an optical disk drive, a CD or DVD drive (R or RW), flash memory, qubit storage, or other removable or fixed media drive.
  • Storage media 518 may include, for example, a hard disk, floppy disk, magnetic tape, optical disk, CD or DVD, or other fixed or removable medium that is read by and written to by media drive 514. As these examples illustrate, the storage media 518 may include a computer-readable storage medium having stored therein particular computer software or data.
  • information storage mechanism 510 may include other similar instrumentalities for allowing computer programs or other instructions or data to be loaded into computing system 500.
  • Such instrumentalities may include, for example, a removable storage unit 522 and an interface 520, such as a program cartridge and cartridge interface, a removable memory (for example, a flash memory or other removable memory module) and memory slot, and other removable storage units 522 and interfaces 520 that allow software and data to be transferred from the removable storage unit 518 to computing system 500.
  • Computing system 500 can also include a communications interface 524.
  • Communications interface 524 can be used to allow software and data to be transferred between computing system 500 and external devices.
  • Examples of communications interface 524 can include a modem, a network interface (such as an Ethernet or other NIC card), a communications port (such as for example, a USB port), a PCMCIA slot and card, etc.
  • Software and data transferred via communications interface 524 are in the form of signals which can be electronic, electromagnetic, optical, or other signals capable of being received by communications interface 524. These signals are provided to communications interface 524 via a channel 528.
  • This channel 528 may carry signals and may be implemented using a wireless medium, wire or cable, fiber optics, or other communications medium.
  • Some examples of a channel include a phone line, a cellular phone link, an RF link, a network interface, a local or wide area network, WiFi,
  • Cloud computing may be used for data storage, retrieval and processing as known to the art.
  • computer program product and “computer- readable storage medium” may be used generally to refer to media such as, for example, memory 508, storage device 518, or storage unit 522. These and other forms of computer-readable storage media may be involved in providing one or more sequences of one or more instructions to processor 504 for execution. Such instructions, generally referred to as "computer program code” (which may be grouped in the form of computer programs or other groupings), when executed, enable the computing system 500 to perform features or functions of embodiments of the current technology.
  • the software may be stored in a computer-readable storage medium and loaded into computing system 500 using, for example, removable storage drive 514, drive 512 or communications interface 524.
  • the control logic in this example, software instructions or computer program code
  • the processor 504 when executed by the processor 504, causes the processor 504 to perform the functions of the technology as described herein.
  • computing system 500 is configured to comply with applicable regulatory requirements of health authorities.
  • computer system 500 can implement appropriate encryption technology to comply with the Food and Drug Administration's regulations on electronic records as set forth in FDA 21 CFR Part 11.

Abstract

Clinical research data associated with a plurality of subjects may be displayed within interfaces having an avatar representation of the plurality of subjects. A set of clinical data associated with the subjects is received. The avatar representation of the subjects is displayed. Also displayed is a visual indicator at a location associated with an anatomical component of the avatar representation. The visual indicator represents at least a portion of the set of clinical research data representing at least two subjects. The location on which the visual indicator is displayed is determined based at least in part on the portion of the set of clinical research data.

Description

DISPLAY OF CLINICAL RESEARCH DATA USING AN AVATAR
BACKGROUND
1. Field:
[0001] The present application relates generally to the display of medical data, and more particularly, to the organization and display of clinical research data using an avatar.
2. Related Art:
[0002] Drug manufacturers generally perform clinical trials to determine the safety and efficacy of a new medical treatment, for example, a new drug. During these trials, the medical treatment is administered to subjects in a test group. These subjects are monitored to gather clinical research data associated with subjects before, during, and after administration of the medical treatment. Based on an analysis of the data collected from the test group, a determination can be made on whether or not the treatment is safe, effective, and suitable for sale to the general public. This approach further extends to the post-marketing phase of treatment, where real-world use data is also collected for a number of safety, efficacy, and cost-effectiveness use cases.
[0003] Traditionally, clinical research data is analyzed and displayed using text-based media. However, it may be difficult to gain a complete understanding of the clinical research data through a strictly textual display of the clinical research data. Further, a strictly textual display of the clinical research data does not provide an efficient and intuitive mechanism for filtering specific types of data from the clinical research data. This is especially true for data collected from large test groups.
[0004] While some applications have been developed to display medical data from a subject's medical record using a visual representation of the subject, these applications merely display data from a single subject. As a result, current applications are unsuitable for displaying clinical research data that includes medical data from numerous subjects. [0005] Thus, an application for electronically displaying medical data, including clinical research data, from multiple subjects is desired.
SUMMARY
[0006] In one exemplary embodiment, clinical research data associated with a plurality of subjects may be displayed within interfaces having an avatar representation of the plurality of subjects. A set of clinical data associated with the subjects is received. The avatar representation of the subjects is displayed. Also displayed is a visual indicator at a location associated with an anatomical component of the avatar representation. The visual indicator represents at least a portion of the set of clinical research data
representing at least two subjects. The location on which the visual indicator is displayed is determined based at least in part on the portion of the set of clinical research data.
DESCRIPTION OF THE FIGURES
[0007] FIG. 1 illustrates an exemplary interface including an avatar representation for displaying medical data for a set of subjects.
[0008] FIG. 2 illustrates another portion of the exemplary interface as depicted in FIG. 1, including an avatar representation.
[0009] FIG. 3 illustrates another exemplary interface comprising an avatar representation.
[0010] FIG. 4 illustrates an exemplary process, in block diagrammatic form, for displaying medical data for a set of subjects.
[0011] FIG. 5 illustrates an exemplary computing system, in block diagrammatic form, that may be used to implement some or all processing functionality of various embodiments herein. DETAILED DESCRIPTION
[0012] The following description is presented to enable a person of ordinary skill in the art to make and use the various embodiments. Descriptions of specific devices, techniques, and applications are provided only as examples. Various modifications to the examples described herein will be readily apparent to those of ordinary skill in the art, and the general principles defined herein may be applied to other examples and applications without departing from the spirit and scope of the various embodiments. Thus, the various embodiments are not intended to be limited to the examples described herein and shown, but are to be accorded the scope consistent with the claims.
[0013] Various embodiments are described below relating to interfaces for displaying medical data. The interfaces may include an avatar for displaying a set of medical data, including clinical research data, associated with a set of subjects. Visual representations of at least a portion of the set of medical data may be displayed with the avatar on or near a portion of the avatar associated with the at least a portion of the set of medical data. The medical data to be displayed with the avatar may be filtered based at least in part on user selections made within the interface. The filters may be objective, subjective, or both. The filters may include subjects, symptoms, severity, medication use, medication compliance, concomitant medication use, existing medical history, diet, laboratory data, quality of life and similar questionnaires, anatomical components, dates, times, representation of motion over time, images, genetic data, drug (or treatment) type, drug (or treatment) response, and the like.
[0014] The interfaces may be used by a patient, subject of a clinical trial, physician, health-care provider, researcher, etc. Additionally, access management functions may be provided to provide different levels of access to different users. For example, a physician may be provided with complete access, such as using one access permission setting, while a researcher may be provided more limited access, such as using another access permission setting.
[0015] FIG. 1 illustrates an exemplary interface 100 for displaying medical data associated with a set of subjects. The medical data may include any psychological or physiological data associated with the subjects. The medical data may further include full or partial medical history data associated with the subjects. In some embodiments, the set of subjects may comprise a test group in a clinical trial. In these embodiments, the medical data may include clinical research data related to clinical trials used to test drugs, treatments, prevention of diseases, radiation therapy, surgical strategies, and the like. Additionally, the medical data may include subject identifications and symptoms, measurements, treatments, and the like, associated with each of the subjects. While specific examples are provided herein, it should be appreciated that interface 100 may be used to display any type of medical data associated with any set of subjects comprising any type of organism (e.g., humans, animals, plants, cells, and the like). Although certain embodiments are described below in connection with displaying clinical research data, it should be recognized that these embodiments can be used in connection with displaying medical or health records of patients.
[0016] Interface 100 may include an avatar portion 101 for displaying a visual representation of the medical data overlaid on avatar 103. Since the medical data may be associated with any type of organism (e.g., human, simian, dog, cat, and the like), avatar 103 may take a form representative of the subjects associated with the medical data being displayed using interface 100. However, the appearance of avatar 103 may or may not correlate exactly with the organism being represented. For example, a graphical representation of a typical dog may be used to display medical data associated with dogs of varying breeds, sizes, and other physical characteristics.
[0017] Similarly, avatar 103 may be gender neutral or gender specific, and may be generally or anatomically correct to reflect girth and height differences. For example, a gender neutral graphical representation of a human may be used for clinical research data that include subjects of both male and female genders. Alternatively, for example, as depicted in FIG. 1, a gender specific avatar of a male may be used for representing medical data that is specific to males. Alternatively, FIG. 3 depicts avatar 103 as a female. [0018] With reference again to FIG. 1, avatar 103 may comprise a two-dimensional (2-D) or three-dimensional (3-D) (inclusive or exclusive of a time dimension component) representation of the set of subjects. Additionally, side-by-side presentations of multiple sets of subject may be provided. For example, one set of subjects can depict a baseline or placebo set for comparison. Additionally, or alternatively, multiple sets can each depict different therapies, such as different drugs, different dosages of the same drug, or different routes of administration of the same or different drugs.
[0019] In some embodiments, avatar 103 may be displayed using varying levels of detail. For instance, in some examples, avatar 103 may be displayed as a skin-coated model that shows no inner components of the avatar. In other examples, avatar 103 may show the inner components of the avatar, such as the bones, muscles, organs, veins, arteries, cells, pathways, and the like. In some embodiments, interface 100 may include options to allow the user to selectively adjust the components displayed with avatar 103. For example, FIG. 1 depicts avatar 103 with certain major organs (e.g., brain, lungs, stomach, intestines, etc.) displayed. FIG. 2 depicts avatar 103 with additional components (e.g., bones, blood vessels, etc.) displayed. As further depicted in FIGS. 1 and 2, the user can switch between the less detailed view in FIG. 1 to the more detailed view in FIG. 2 by an appropriate switch, such as a software or hardware implemented switch. In the example depicted in FIG. 1, the user may select the "Anatomy" button to switch views. Also, specific physiological and/or anatomical systems, subsystems or components may be selected for viewing using checkboxes, as an exemplary user interface, associated with the specific components. Thus, in some embodiments, specific views may comprise the circulatory system, lymphatic system, muscle system, skeletal system, nervous system, skin, bones, muscles, organs, veins, arteries, cells, pathways, combinations thereof and selections thereof.
[0020] In some embodiments, a user may be allowed to manipulate avatar 103 using features such as zoom-in, zoom-out, scroll, pan, or rotate. Also, a user can move from summary infonnation to detailed information, that is, can drill down into greater levels of detail, and vice versa. These features can be incorporated with the access management functions described above. For example, only users with the necessary access permission setting may be permitted to drill down below a specific level of detail.
[0021] Avatar portion 101 may further include one or more visual indicators 105 for visually representing at least a portion of the medical data associated with one or more subjects from the set of subjects. As depicted in FIG. 1, visual indicator 105 can include a pointer portion 104 and a caption portion 106. As will be illustrated below, using visual indicator 105 in conjunction with avatar 103 provides a user with a visual representation of the medical data that allows a user to more easily analyze the data than by using a strictly textual display of the medical data. Indicators 105 may also be used to associate audio and video and the like to represent data, such as pulse, heartbeat, dosing events, etc.
[0022] Visual indicator 105 may represent data associated with a single subject from the set of subjects or may represent data associated with multiple subjects from the set of subjects. Similarly, visual indicator 105 may represent a single medical condition (e.g., head injury, stomach pain, a disease, and the like) or may represent multiple medical conditions. In one embodiment, a series of avatars 103 may be plotted against an axis, such as time, to illustrate a change over time, such as a change in pain or symptom.
[0023] Visual indicator 105 may be positioned on or near an anatomical component of a subject (e.g., head, arm, leg, etc.) associated with the medical data being displayed. For example, as depicted in FIG. 1, pointer portion 104 of a visual indicator 105, which represents data associated with headaches, is positioned on the brain of avatar 103. As also depicted in FIG. 1, visual indicator 105 represent data associated with conditions that are not associated with a particular anatomical component. In particular, FIG. 1 depicts visual indicators 105 representing data associated with conditions for
"GENERAL BODY" and "ACCIDENTAL INJ" (accidental injury), which are not associated with particular anatomical components of avatar 103.
[0024] Visual indicator 105 may be used to represent any type of subject-associated, and/or medical data. For example, visual indicator 105 may be used to represent the total number of subjects from the set of subjects experiencing a particular condition, the fraction of total subjects experiencing a condition associated with a particular body part, severity of pain, type of pain, drag or treatment response, and the like. Environmental, historical and/or metadata may also be represented by an indicator 105. Visual indicator 105 may comprise symbols (static and dynamic), change in intensity over time, numerical representations (e.g., total counts, fractions, and the like), color representations (e.g., colors associated with numerical values or symptoms), patterns (e.g., shading or textures), and tactile (haptic) capability where possible, or combinations thereof. For example, visual indicator 105 may include a percentage value that identifies the percentage of subjects in the set of subjects that experienced a specific medical condition. In another example, the indicator may be an integer representing the number of subjects that experienced the specific medical condition during a clinical trial. In yet another example, as depicted in FIG. 1, the indicator may comprise text, such as "HEADACHE," to indicate that at least one subject experienced headaches. As also depicted in FIG. 1, the indicator may also include an integer identifying the number of subjects experiencing the headaches.
[0025] As described above, visual indicator 105 may include a fraction comprising a numerator representing the number of subjects experiencing a specific medical condition and a denominator representing the total number of subjects in the set of subjects. The fraction may or may not be written in lowest terms (e.g., by dividing the numerator and the denominator by their greatest common divisor). For example, the fraction "1/10," may indicate that for every ten subjects, conditions, events, and the like represented by the medical data experienced a specific medical condition. Using a visual indicator having a fraction positioned on or near an associated anatomical component of the avatar provides a user of interface 100 with information relating to the probability that a particular condition occurs. This may be used, for example, to identify correlations between the treatment being studied and potential side-effects. Such fraction may be additionally or alternatively expressed as a percentage or as a pictorial presentation, color, intensity, or sound.
[0026J As described above, the color or intensity of visual indicator 105 may be varied to convey information about the medical data. The color or intensity may be based on the medical condition, the number of subjects in the clinical trial, the number of subjects experiencing the medical condition, the percentage of subjects experiencing the medical condition, the anatomical component associated with the medical data, the severity of the medical condition, or any combination thereof with respect to a color mapping scheme. For example, the selected values of the medical data may be mapped to a hue ranging from 0 to 120. The values of 0 and 120 may represent red and green, respectively, as in the cylindrical coordinate color representation known in the art as hue, saturation, and lightness ("HSL") and hue, saturation, and value ("HSV") cylindrical- coordinate representations. Under this color mapping scheme, for example, the indicator may be green if no subjects experienced a particular condition, yellow if half the subjects experienced the condition, red if all of the subjects experienced the condition, and combinations of these colors for intermediate values of subjects experiencing the condition. This color mapping scheme is only provided as an example, as other color mapping schemes may also be used. In the case where color representation is not possible, appropriate grey-scale representations (with or without gamma corrections) may also be used, as may any non-color depiction known to the art, such as hatching, cross- hatching, lines, shading and symbols. Alternatively, when the value represented by a color or intensity is below a pre-specified value, such as a pre-specified low value, a flag may be used in place of the color or intensity. Additionally or alternatively, mapping schemes such as heat maps, contour maps, cluster maps, fractal maps and the like may be employed.
[0027] As depicted in FIG. 1, in one embodiment, pointer portion 104 of visual indicator 105 may be used to represent aspects of a condition in addition to identifying the relevant anatomical component of avatar 103. For example, various symbols are used to indicate various severities and corresponding actions taken related to conditions for headaches, mouth ulcers, common colds, vomiting, and constipation. The symbol associated with the conditions for headaches, common cold, vomiting, and constipation indicates an adverse event with no further action taken. The symbol associated with the condition for mouth ulcers indicates a condition that caused the subject to discontinue from the trial. The symbol associated with the condition for nausea indicates a change in dosing or change in concomitant medications that the event caused or required. [0028] In one embodiment, visual indicator 105 may be an icon for an anatomical component, such as an organ or cell, of avatar 103. For example, visual indicator 105 may be an icon depicting the heart. As discussed above, the color of visual indicator 105 can be varied to convey information about the medical conditions of the anatomical component (in this example, hearts of the subjects). Additionally or alternatively, visual indicator 105 can be animated (with and without sound components) to convey information about the medical conditions of the anatomical component. For example, visual indicator 105 can be animated to pulse to convey information, such as average heart rate of subjects. It should be recognized that various types of animation can be associated with various types of information. For example, pulsing of arteries can depict hypertension, throbbing of the brain can depict headaches, pulsation of the stomach can depict nausea, and the like. Other modes of animation may be used, alternatively or additionally, include blinking, expanding, contracting, fade-in, fade-out, and the like.
[0029] In one embodiment, visual indicator 105 may be associated with haptic technology to provide tactile feedback to the user. For example, in addition to or as an alternative to providing a visual animation, such as a pulsing image, vibrations can be applied to the user, such as the user's fingertip. In such case, vibration can be modulated to convey information.
[0030] In some embodiments, auditory feedback, that is, sound, can additionally be associated with visual indicator 105, or sound may be used as an alternative thereto. For example, when visual indicator 105 depicts the heart, a heartbeat sound can be associated with the icon. In such case, sound can be modulated, such as in phase or intensity, or both, to convey information.
[0031] In one embodiment, additional information may be presented to a user in response to the user selecting or indicating interest in an anatomical component of avatar 103 or a visual indicator 105. For example, a user may be presented with a list of subjects that experienced a medical condition related to the elbow in response to the user selecting an elbow of avatar 103. In another example, a user may be presented with medical data, such as x-rays or lab results, relating to visual indicator 105 in response to the user selecting the indicator.
[0032] The medical data represented by visual indicator 105 may be filtered based on a variety of categories, such as subject, symptom, time, and the like. Interface 100 may include displays representing some or all of the filter categories. For example, FIG. 1 illustrates portions 107, 111, and 115 representing categories that may be used to filter the medical data displayed in avatar portion 101. Portions 107, 111, and 115 are described below with respect to specific filter categories. However, it should be appreciated that the specific categories displayed in interface 100 may be varied depending on the preference of the user and that any combination of categories may be used. Additionally, any number of filter categories may be included in interface 100.
[0033] In some embodiments, interface 100 may include subject portion 107 for displaying a list of one or more subjects 109 from the set of subjects. List of one or more subjects 109 may comprise text (e.g., the subject's name), images (such as the subject's face), numerical identifiers, phenotypic information (e.g., blue eyes, height, etc.), genomic information, historical medical or environmental information (such as past injuries), combinations thereof, or selections thereof. In some embodiments, subjects may be added, removed, selected, or unselected, within subject portion 107. Subjects may be added to or removed from subject portion 107 to include or exclude, respectively, those subjects from the set of subjects. Similarly, subjects may be selected or unselected to display, hide, or not display, respectively, medical data associated with those subjects in avatar portion 101. Thus, a user may selectively include data associated with a subset of subjects (e.g., all male subjects) from the set of subjects by highlighting, or otherwise selecting, all the male subjects from subject portion 107. This may be used, for example, to identify correlations between a subset of subjects (e.g., males) and a particular side- effect.
[0034] Exemplary interface 100 may further include symptom portion 111 for displaying a list of one or more symptoms 113. List of one or more symptoms 113 may include a list of all known symptoms or a subset of all known symptoms. For example, list of one or more symptoms 113 may only include those symptoms experienced by subjects in the set of subjects. Alternatively, list of one or more symptoms 113 may include all possible symptoms that may be experienced by the subjects. In some embodiments, similar to subject list portion 107, symptoms may be selected or unselected to display or not display, respectively, medical data associated with those symptoms in avatar portion 101. Thus, a user may selectively include data associated with a subset of symptoms (e.g., mouth ulcer) from the set of symptoms by highlighting, or otherwise selecting, "mouth ulcer" from symptom portion 111. Additionally, in some
embodiments, counts of subjects experiencing each of the symptoms in list of one or more symptoms 113 may be included within symptom portion 111.
[0035] Exemplary interface 100 may further include time portion 115 for displaying time data associated with the medical data. Time data may include data such as time a drug or treatment was administered, time a symptom and/or a condition was observed, time (e.g., time of a patient activity, such as eating, sleeping, moving, exercising, etc.), changes in morphology, changes in activity, changes in biochemical parameters, changes in cognitive behavior, changes in coordination and visual acuity, and the like. Time data may be displayed sequentially in a list, or may be displayed graphically (as depicted in FIG. 1), as on a timeline, or as a video over time. Time portion 115 data may comprise time (hours, minutes, seconds or smaller divisions), calendar data such as day of the week, month and/or year, or combinations thereof. Time portion 115 data may be based upon an absolute standard (such as UTC time) and may identify a starting and ending day, month, and year. The time data and/or range may also be a relative time range, such as the prior (relative to a time zero or a pre-selected start time/date) week, past month, or the first two years of the clinical trial, for example. This may be advantageous for understanding clinical research data during a specific duration of the clinical trial.
[0036] In some embodiments, times or ranges of time may be selected to display medical data associated with those times in avatar portion 101. Thus, a user may selectively include data associated with a subset of time (e.g., between January 2010 and March 2010) by entering start and end times, or otherwise selecting a desired time range from time portion 115. In some embodiments, interface 100 allows a user to filter the medical data according to any or all categories represented by portions 107, 111, and 115. For example, a user may filter the medical data displayed in avatar portion 101 to include only male subjects by making the appropriate selections in subject portion 107. The user may optionally further filter the data by displaying only male subjects experiencing head pain by further highlighting, or otherwise selecting, "mouth ulcer" from the list of symptoms in symptom portion 111. A user may optionally further filter the data by displaying only male subjects experiencing head pain observed in the past 3 months by further highlighting, or otherwise selecting, a range of time including the last 3 months from time portion 115.
[0037] In one embodiment, interface 100 may be used to track drug dosing events and to monitor the effects that the drug has on one or more subjects. For example, oral dosage forms (such as pills) comprising circuitry for identifying an ingestion event and communicating the occurrence of the ingestion event (such as by uplink to an external monitor/receiver/transmitter/recorder) may be used to track drug dosing events. These pills may be administered to a plurality of subjects identified in subject portion 107 of interface 100. The time of the ingestion event may be recorded and displayed within time portion 115. This can also extend to a variety of other drug delivery modalities, such as inhalation, injection, infusion, transdermal, and the like. In one embodiment, data from the ingestion of one or more drug dosing events may be transmitted automatically or semi-automatically to interface 100, or may be entered manually. Additionally, the subject may be monitored for symptoms listed in symptom portion 111. Using the data displayed in interface 100, a user may identify correlations between the drug dosing events and symptoms of conditions experienced by the subjects. In another example, the corresponding pharmacokinetic and/or pharmacodynamic properties of dosing events may be represented on interface 100, and the capabilities provided by avatar 103 can permit the user to zoom in or out of levels of anatomical, cellular or pathway of interest using the capabilities provided by avatar 103.
[0038] In one embodiment, interface 100 may be used to display information obtained using biomarkers. For example, measurements associated with a biomarker can be displayed to the user by associating the measurements with the appropriate anatomical component of avatar 103.
[0039] FIG. 4 illustrates an exemplary process 400 for displaying medical data associated with a set of subjects. At block 401, a set of medical data comprising medical data associated with each of a plurality of subjects is received or accessed. The medical data of the set of medical data may be associated with an anatomical component of a subject. At block 403, an avatar representation of the plurality of subjects may be displayed. In some embodiments, the avatar representation of the plurality of subjects may be similar or identical to avatar 103 of FIG. 1. At block 405, a visual indicator may be displayed at a location associated with an anatomical component of the avatar representation of the plurality of subjects. The visual indicator may represent at least a portion of the set of medical data. The location of the visual indicator may be determined based at least in part on the at least a portion of the set of medical data. The visual indicator may be similar or identical to visual indicator 105 of FIG. 1. In some embodiments, the at least a portion of the set of medical data may be selected based on one or more filters selected by a user. The filters may be objective, subjective, or both. The filters may include subjects, symptoms, severity, medication compliance, concomitant medication use, existing medical history, diet, laboratory data, quality of life and similar questionnaires, anatomical components, dates, representation of motion over time, images, genetic data, drug (or treatment) type, drug (or treatment) response, and the like. While the functions performed in process 400 were described in a particular order, it should be appreciated that the functions performed may be performed in any order.
[0040] FIG. 5 illustrates an exemplary computing system 500 that may be employed to implement processing functionality for various aspects of the current technology (e.g., as a user/client device, media server, media capture server, media rules server, rules store, media asset library, activity data logic/database, combinations thereof, and the like). Those skilled in the relevant art will also recognize how to implement the current technology using other computer systems or architectures. Computing system 500 may represent, for example, a user device such as a medicament (medication) dispensing device, desktop, mobile phone, personal entertainment device, cameras, microphones, DVR, and so on, a mainframe, server, or any other type of special or general purpose computing device as may be desirable or appropriate for a given application or environment. Computing system 500 includes a human detectable interface to display the medical, avatar, or other information in visual, auditory or tactile form. In one embodiment, the interface comprises a visual display monitor (not shown). Computing system 500 can include one or more processors, such as a processor 504. Processor 504 can be implemented using a general or special purpose processing engine such as, for example, a microprocessor, microcontroller or other control logic. In this example, processor 504 is connected to a bus 502 or other communication medium.
[0041] Computing system 500 can also include a main memory 508, such as random access memory (RAM) or other dynamic memory, for storing information and instructions to be executed by processor 504. Main memory 508 also may be used for storing temporary variables or other intermediate information during execution of instructions to be executed by processor 504. Computing system 500 may likewise include a read only memory ("ROM") or other static storage device coupled to bus 502 for storing static information and instructions for processor 504.
[0042] The computing system 500 may also include information storage mechanism 510, which may include, for example, a media drive 512 and a removable storage interface 520. The media drive 512 may include a drive or other mechanism to support fixed or removable storage media, such as a hard disk drive, a floppy disk drive, a magnetic tape drive, an optical disk drive, a CD or DVD drive (R or RW), flash memory, qubit storage, or other removable or fixed media drive. Storage media 518 may include, for example, a hard disk, floppy disk, magnetic tape, optical disk, CD or DVD, or other fixed or removable medium that is read by and written to by media drive 514. As these examples illustrate, the storage media 518 may include a computer-readable storage medium having stored therein particular computer software or data.
[0043] In alternative embodiments, information storage mechanism 510 may include other similar instrumentalities for allowing computer programs or other instructions or data to be loaded into computing system 500. Such instrumentalities may include, for example, a removable storage unit 522 and an interface 520, such as a program cartridge and cartridge interface, a removable memory (for example, a flash memory or other removable memory module) and memory slot, and other removable storage units 522 and interfaces 520 that allow software and data to be transferred from the removable storage unit 518 to computing system 500.
[0044] Computing system 500 can also include a communications interface 524. Communications interface 524 can be used to allow software and data to be transferred between computing system 500 and external devices. Examples of communications interface 524 can include a modem, a network interface (such as an Ethernet or other NIC card), a communications port (such as for example, a USB port), a PCMCIA slot and card, etc. Software and data transferred via communications interface 524 are in the form of signals which can be electronic, electromagnetic, optical, or other signals capable of being received by communications interface 524. These signals are provided to communications interface 524 via a channel 528. This channel 528 may carry signals and may be implemented using a wireless medium, wire or cable, fiber optics, or other communications medium. Some examples of a channel include a phone line, a cellular phone link, an RF link, a network interface, a local or wide area network, WiFi,
BlueTooth, ZigBee, and other communications protocols and/or channels. Cloud computing may be used for data storage, retrieval and processing as known to the art.
[0045] In this document, the terms "computer program product" and "computer- readable storage medium" may be used generally to refer to media such as, for example, memory 508, storage device 518, or storage unit 522. These and other forms of computer-readable storage media may be involved in providing one or more sequences of one or more instructions to processor 504 for execution. Such instructions, generally referred to as "computer program code" (which may be grouped in the form of computer programs or other groupings), when executed, enable the computing system 500 to perform features or functions of embodiments of the current technology.
[0046] In an embodiment where the elements are implemented using software, the software may be stored in a computer-readable storage medium and loaded into computing system 500 using, for example, removable storage drive 514, drive 512 or communications interface 524. The control logic (in this example, software instructions or computer program code), when executed by the processor 504, causes the processor 504 to perform the functions of the technology as described herein.
[0047] In one embodiment, computing system 500 is configured to comply with applicable regulatory requirements of health authorities. For example, in the US, computer system 500 can implement appropriate encryption technology to comply with the Food and Drug Administration's regulations on electronic records as set forth in FDA 21 CFR Part 11.
[0048] It will be appreciated that, for clarity purposes, the above description has described embodiments of the technology with reference to different functional units and processors. However, it will be apparent that any suitable distribution of functionality between different functional units, processors or domains may be used without detracting from the technology. For example, functionality illustrated to be performed by separate processors or controllers may be performed by the same processor or controller. Hence, references to specific functional units are only to be seen as references to suitable means for providing the described functionality, rather than indicative of a strict logical or physical structure or organization.
[0049] Although a feature may appear to be described in connection with a particular embodiment, one skilled in the art would recognize that various features of the described embodiments may be combined. Moreover, aspects described in connection with an embodiment may stand alone.

Claims

CLAIMS What is claimed is:
1. A method for displaying clinical research data associated with a plurality of subjects, the method comprising:
receiving, by a computer processor, a set of clinical research data comprising clinical research data associated with each of a plurality of subjects;
causing a display of an avatar representation of the plurality of subjects;
causing a display of a visual indicator at a first location associated with an anatomical component of the avatar representation, wherein the visual indicator represents at least a portion of the set of clinical research data representing at least two subjects of the plurality of subjects, and wherein the first location is determined based at least in part on the at least a portion of the set of clinical research data.
2. The method of claim 1 , wherein the visual indicator comprises a color or intensity representing a numerical value associated with the at least a portion of the set of clinical research data.
3. The method of claim 2, wherein the visual indicator is a flag when the numerical value is below a pre-specified value.
4. The method of claim 1 , wherein the visual indicator comprises a numerical ratio based at least in part on a numerical value associated with the at least a portion of the set of clinical research data.
5. The method of claim 1 , wherein the visual indicator comprises an icon of a system, subsystem, organ, or cell of the object.
6. The method of claim 5, further comprising animating the icon to convey information about the organ or cell.
7. The method of claim 1, further comprising providing auditory feedback.
8. The method of claim 1, wherein the at least a portion of the set of clinical research data is selected from the set of clinical research data based on one or more filter options selected by a user.
9. The method of claim 8, wherein the one or more filter options comprise one or more members selected from the group consisting of subject, symptom, and time.
10. The method of claim 1 further comprising causing a display of additional clinical research data in response to a user selection of the visual indicator or the anatomical component.
11. The method of claim 1, wherein the set of clinical data comprises data associated with drug dosing events.
12. A system for displaying medical data associated with a plurality of subjects, the system comprising:
a computer processor for receiving and processing a set of medical data associated with each of a plurality of subjects;
software for generating, and displaying on a human detectable interface, an avatar representation of the plurality of subjects, said software generating on the display a visual indicator at a location associated with an anatomical component of the avatar
representation, wherein the visual indicator represents at least a portion of the set of medical data representing at least two subjects of the plurality of subjects, and wherein the location is determined based at least in part on the at least a portion of the set of medical data.
13. A computer-readable storage medium comprising program code for displaying a result of a clinical trial, the program code comprising instructions for:
receiving, by a computer processor, a set of clinical research data comprising clinical data associated with each of a plurality of subjects; causing a display of an avatar representation of the plurality of subjects;
causing a display of a visual indicator at a location associated with an anatomical component of the avatar representation, wherein the visual indicator represents at least a portion of the set of clinical research data representing at least two subjects of the plurality of subjects, and wherein the location is determined based at least in part on the at least a portion of the set of clinical research data.
14. The computer-readable storage medium of claim 13, wherein the visual indicator comprises a color or intensity representing a numerical value associated with the at least a portion of the set of clinical research data.
15. The computer-readable storage medium of claim 13, wherein the visual indicator comprises a numerical ratio based at least in part on a numerical value associated with the at least a portion of the set of clinical research data.
16. The computer-readable storage medium of claim 13, wherein the at least a portion of the set of clinical research data is selected from the set of clinical research data based on one or more filter options selected by a user.
17. The computer-readable storage medium of claim 16, wherein the one or more filter options comprise one or more members selected from the group consisting of subject, symptom, and time.
18. The computer-readable storage medium of claim 13 further comprising instructions for causing a display of additional clinical research data in response to a user selection of the visual indicator or the anatomical component.
19. The computer-readable storage medium of claim 13, wherein the set of clinical research data comprises data associated with drug dosing events.
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