Telemetrics and alert system

• US 9,861,281 B2
• Filed: 03/18/2016
• Issued: 01/09/2018
• Est. Priority Date: 03/19/2015
• Status: Active Grant

• Current Assignee: Accenture Global Services Limited (Accenture PLC)
• Original Assignee: Accenture Global Services Limited (Accenture PLC)
• Inventors: Gandhi, Jimit Jaykumar
• Primary Examiner(s): Timory, Kabir A
• Application Number:
  US15/074,405
• Publication Number:
  US 20160270659A1
• Time in Patent Office: 662 Days
• CPC Class Codes: A61B 5/0015 characterised by features of the telemetry system
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: G16B 50/00 ICT programming tools or database systems specially adapted for bioinformatics
• CPC Class Codes: G16B 50/30 Data warehousing; Computing architectures
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: H04Q 2209/40 using a wireless architecture
• CPC Class Codes: H04Q 2209/43 using wireless personal area networks [WPAN], e.g. 802.15, 802.15.1, 802.15.4, Bluetooth or ZigBee
• CPC Class Codes: H04Q 2209/823 where the data is sent when the measured values exceed a threshold, e.g. sending an alarm
• CPC Class Codes: H04Q 9/00 Arrangements in telecontrol or telemetry systems for selectively calling a substation from a main station, in which substation desired apparatus is selected for applying a control signal thereto or for obtaining measured values therefrom

Abstract

A telemetric monitoring system and data analysis tool is provided that assists in trial management by identifying relationships between subject profiles and monitors physiological attributes using telemetric devices. The tool may identify subjects having certain response predispositions based on their profiles, which may be used to better select subjects to enroll in a trial. The system may monitor the physiological attributes of a subject to identify adverse events, and may generate event alerts that are sent to investigators over a communication channel. The system may present the investigators with a dashboard through which they can investigate and respond to event alerts.

Claims

1. A method comprising:

building, by a processor of a server, a profile database comprising subject profiles of one or more subject traits for one or more subjects;

analyzing, by the processor, the subject profiles in the profile database and tagging a subject profile for the one or more subjects with a response predisposition based on the analysis, the response predisposition representing a likelihood that an individual subject will have a particular response to a specific treatment;

enrolling, by the processor, the one or more subjects in a trial and storing corresponding enrollment indications in a trial management database;

monitoring, with a telemetric device in communication with the server, one or more physiological attributes of the one or more subjects enrolled in the trial to identify an event occurrence, the monitoring comprising,

receiving, by the processor, data indicative of the one or more physiological attributes from the telemetric device,

defining, by the processor, a baseline level for each of the one or more physiological attributes,

determining, by the processor, a relative change for each of the one or more physiological attributes based on data obtained at different points in time;

identifying, by the processor, an event occurrence based on a determination that the relative change has exceeded the baseline level for at least one of the physiological attributes, and

validating, by the processor, the event occurrence based on the subject profiles;

generating, by the processor, an event alert based on an identification of the event occurrence;

generating, by the processor, an interactive interface for the event alert providing a representation of the subject profile for a subject associated with the event alert and a representation of the one or more physiological attributes for the subject associated with the event alert;

including, by the processor, a link in the event alert for the interactive interface that is generated; and

transmitting, by the processor, the event alert over a communication channel to a remote device for a trial investigator.

2. The method of claim 1, wherein building the profile database further comprises:

obtaining a biological sample of a subject for analysis;

analyzing the biological sample for the one or more subject traits and generating a subject specific profile based on the analysis; and

storing the subject specific profile in the profile database and associating the subject specific profile with a subject identification number and each of the one or more subject traits.

3. The method of claim 1, wherein tagging the one or more subjects comprises, for each individual subject of the one or more subjects, performing clustering analytics on the subject profiles to identify a combination of subject traits indicative of the response predisposition.

4. The method of claim 3, wherein performing the clustering analytics also accounts for subject attribute data, subject history data, and known response predispositions.

5. The method of claim 1, wherein enrolling the one or more subjects comprises, for each individual subject of the one or more subjects:

determining whether the individual subject matches criteria for the trial defined in the trial management database;

determining whether the individual subject has been tagged with response predispositions associated with the trial;

filtering out the individual subject based on a determination that the response predisposition is unfavorable; and

enrolling the individual subject based on a determination that the response predisposition is favorable.

6. The method of claim 1, further comprising:

tracking the event alert to determine whether the event alert has been reviewed and whether any action was taken; and

escalating the event alert based on a determination that the alert has not been reviewed or a determination that no action was taken.

7. The method of claim 2, wherein the analyzing the biological sample comprises performing a microarray analysis on the biological sample and generating a subject specific genomic profile based on the analysis.

8. The method of claim 1, wherein the one or more physiological attributes are vital signs, including one or more of a heart beat rate, a blood pressure, a body temperature, and a respiration rate.

9. A system comprising:

a processor and a memory in communication with the processor, the processor configured to;

build a profile database comprising subject profiles of one or more subject traits for one or more subjects;

analyze the subject profiles in the profile database and tag a subject profile for the one or more subjects with a response predisposition based on the analysis, the response predisposition representing a likelihood that an individual subject will have a particular response to a specific treatment;

enroll the one or more subjects in a trial and store corresponding enrollment indications in a trial management database;

receive, from a telemetric device configured to monitor one or more physiological attributes of the one or more subjects enrolled in the trial, data indicative of one or more physiological attributes from the telemetric device;

define a baseline level for each of the one or more physiological attributes;

determine a relative change for each of the one or more physiological attributes based on data obtained at different points in time;

identify an event occurrence based on a determination that the relative change has exceeded the baseline level for at least one of the physiological attributes;

generate, in response to the determination that the relative change has exceeded the baseline level for at least one of the physiological attributes, an interactive interface providing a representation of the subject profile for a subject associated with the event occurrence and a representation of the one or more physiological attributes for the subject associated with the event occurrence;

generate an event alert based on an identification of the event occurrence, the event including a link in the event alert for the interactive interface that is generated; and

transmit the event alert to a trial investigator over a communication channel.

10. The system of claim 9, wherein in building the profile database the processor is configured to:

obtain a biological sample of a subject for analysis;

analyze the biological sample for the one or more subject traits and generate a subject specific profile based on the analysis; and

store the subject specific profile in the profile database and associating the subject specific profile with a subject identification number and each of the one or more subject traits.

11. The system of claim 9, wherein in tagging the one or more subjects, the processor, for each individual subject of the one or more subjects, is configured to:

perform clustering analytics on the subject profiles to identify a combination of subject traits indicative of the response predisposition.

12. The system of claim 11, wherein the processor is configured to perform clustering analytics that also account for subject attribute data, subject history data, and known response predispositions.

13. The system of claim 9, wherein in enrolling the one or more subjects, the processor, for each individual subject of the one or more subjects, is configured to:

determine whether the individual subject matches criteria for the trial defined in a criteria database;

determine whether the individual subject has been tagged with response predispositions associated with the trial;

filter out the individual subject based on a determination that the response predisposition is unfavorable; and

enroll the individual subject based on a determination that the response predisposition is favorable.

14. The system of claim 9, wherein the processor is further configured to:

track the event alert to determine whether the event alert has been reviewed and whether any action was taken; and

escalate the event alert based on a determination that the alert has not been reviewed or a determination that no action was taken.

15. The system of claim 10, wherein in analyzing the biological sample, the processor is configured to:

perform a microarray analysis on the biological sample and generate a subject specific genomic profile based on the analysis.

16. The system of claim 9, wherein the one or more physiological attributes are vital signs, including one or more of a heart beat rate, a blood pressure, a body temperature, and a respiration rate.

17. The system of claim 9, wherein the processor is further configured to:

determine, by the processor, based the analysis of the subject profiles, a confidence value that the event occurrence corresponds to the particular response to the specific treatment; and

include an indication of the confidence value in the interactive interface.