# US 2018/0025133 A1 · System for guiding clinical decisions using improved processing of data collected during a clinical trial > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2018/0025133 A1 - Document ID: US20180025133A1 - Status: Published application - Kind: A1 - Application number: 15/656,924 - Filed: 2017-07-21 - Published: 2018-01-25 - Earliest claimed: 2016-07-21 - Assignees: MedAvante-ProPhase, Inc. - Applicants: MedAvante-ProPhase, Inc. - Inventors: Mark G.A. OPLER; Sofija JOVIC - Web page: https://patentgrep.com/patent/US20180025133A1 ## CPC - G16H 10/20: for electronic clinical trials or questionnaires - G16H 10/60: for patient-specific data, e.g. for electronic patient records - G16H 50/20: for computer-aided diagnosis, e.g. based on medical expert systems - G16H 15/00: ICT specially adapted for medical reports, e.g. generation or transmission thereof - G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA ## Abstract A system for providing improved processing of data collected during a clinical trial. The system includes a portable electronic device configured to be operated by a clinician and/or a patient. The portable electronic device is configured for collecting data related to the condition of the patient participating in the clinical trial. The system also includes a controller for processing data collected from the patient. The data received from the patient includes AV data, bio sensor data, and clinician data based on information inputted into the portable electronic device by the clinician in response to an interview of the patient. The controller is configured to process the AV, bio data sensor and clinician data and output a recommended course of action related to the patient's participation in the clinical trial based on the data received from the patient. ## Claims ### Claim 1 A system for providing improved processing of data collected during a clinical trial, comprising: a portable electronic device configured to be operated by a clinician and/or a patient, wherein the portable electronic device is configured for collecting data related to the condition of the patient participating in the clinical trial; a controller for processing data collected from the patient; wherein the data received from the patient includes video data including images of the patient; wherein the data includes bio data from a bio sensor attached to the patient; wherein the data includes clinician data based on information inputted into the portable electronic device by the clinician in response to an interview of the patient; and wherein the controller is configured to process the video data, bio data and clinician data and output a recommended course of action related to the patient's participation in the clinical trial based on the data received from the patient. ### Claim 2 (depends on 1) The system of claim 1, wherein the data includes patient reported data that is captured by the patient and transmitted to the controller. ### Claim 3 (depends on 2) The system of claim 2, wherein the controller is configured to compare the patient reported data with patient reported data received at an earlier point in time and output a prompt to the patient to confirm that the patient intended for the patient reported data to be captured. ### Claim 4 (depends on 2) The system of claim 2, wherein the bio data and the patent reported data are associated with a time that the data was recorded and wherein the controller is configured to output the recommended course of action based on a difference in time between the bio data and the patient reported data. ### Claim 5 (depends on 2) The system of claim 2, wherein the controller is configured to provide an output that includes discrepancies between the patient reported data and the bio data. ### Claim 6 (depends on 1) The system of claim 1, wherein the clinician data includes data related to the interaction of the clinician with the portable electronic device including the revisions made to the clinician data by the clinician and the amount of time associated with the clinician's interaction with the portable electronic device, and wherein the controller is configured to adjust the recommended course of action based on the interaction of the clinician with the portable electronic device. ### Claim 7 (depends on 1) The system of claim 1, wherein the video data, bio data and the clinician data are associated with a time that the data was recorded and wherein the controller is configured to provide an output that includes a display of, for a given point in time, both the clinician data and the video data to thereby allow a secondary clinician to perform a quality review of the clinician data. ### Claim 8 (depends on 1) The system of claim 1, wherein the recommended course of action includes screening the patient out of the clinical trial or triggering a safety protocol. ### Claim 9 (depends on 1) The system of claim 1, wherein the data received the patient includes audio data that is synchronized with the video data. ### Claim 10 A system for providing improved processing of data collected during a clinical trial, comprising: a portable electronic device configured to be operated by a clinician and/or a patient, wherein the portable electronic device is configured for collecting data related to the condition of the patient participating in the clinical trial; a controller for processing data collected from the patient, wherein the electronic device is operatively connected to the controller so that data can be transferred between the device and the controller; wherein the data received from the patient includes audio/video (AV) data including images and audio of the patient; wherein the data includes bio data from a bio sensor attached to the patient; wherein the data includes patient reported data that is captured by the patient and transmitted to the controller; wherein the data includes clinician data based on information inputted into the portable electronic device by the clinician in response to an interview of the patient; and wherein the controller is configured to process the video data, bio data, the patient reported data and the clinician data and output a report that displays permits a secondary clinician to conduct an independent review of the quality of the clinician data. ### Claim 11 (depends on 10) The system of claim 10, wherein the report includes a display of, for a given point in time, both the clinician data and the AV data to thereby allow the secondary clinician to perform a quality review of the clinician data. ### Claim 12 (depends on 10) The system of claim 10, wherein the clinician data includes data related to the interaction of the clinician with the portable electronic device including the revisions made to the clinician data by the clinician and the amount of time associated with the clinician's interaction with the portable electronic device, and wherein the controller is configured to output a report that displays both the clinician data and the AV data to thereby allow the secondary clinician to perform a quality review of the clinician data. ### Claim 13 (depends on 10) The system of claim 10, wherein the data includes secondary clinician data based on information inputted into the portable electronic device by a secondary clinician in response to a review of the AV data, the bio data and the patient reported data; and wherein the controller is configured to process the clinician data and the secondary clinician data and output a report that displays discrepancies between the secondary clinician data and the clinician data. ### Claim 14 (depends on 10) The system of claim 10, wherein the patient reported data includes data related to the interaction of the patient with the portable electronic device including the revisions made to the patient reported data by the patient and the amount of time associated with the patient's interaction with the portable electronic device, and wherein the controller is configured to output a report that displays the patient reported data and the bio data to thereby allow the secondary clinician to perform a quality review of the patient reported data. ### Claim 15 A system for providing improved processing of data collected during a clinical trial that includes a group of patients, wherein at least one patient is treated with a placebo, the system comprising: a portable electronic device configured to be operated by a clinician and/or one of the group of patients, wherein the portable electronic device is configured for collecting data related to the condition of the patient participating in the clinical trial; a controller for processing data collected from the one of the group of patients, wherein the electronic device is operatively connected to the controller so that data can be transferred between the device and the controller; wherein the data received from the one of the group of patients includes video data including images of the one of the group of patients; wherein the data includes bio data from a bio sensor attached to one of the group of patients; wherein the data includes patient reported data that is captured by one of the group of patients and transmitted to the controller; wherein the data includes clinician data based on information inputted into the portable electronic device by the clinician in response to an interview of one of the group of patients; and wherein the controller is configured to process the video data, the bio data, the patient reported data and the clinician data and produce a report that includes a display of a likelihood that one of the group of patients will drop out of the clinical trial or a likelihood that one of the group of patients will respond to the placebo. ### Claim 16 (depends on 15) The system of claim 15, wherein the clinician data includes data related to the interaction of the clinician with the portable electronic device including the revisions made to the clinician data by the clinician and the amount of time associated with the clinician's interaction with the portable electronic device, and wherein the controller is configured to output a report that displays both the clinician data and the AV data to thereby allow the secondary clinician to perform a quality review of the clinician data. ### Claim 17 (depends on 15) The system of claim 15, wherein the data includes secondary clinician data based on information inputted into the portable electronic device by a secondary clinician in response to a review of the AV data, the bio data and the patient reported data; and wherein the controller is configured to process the clinician data and the secondary clinician data and output a report that displays discrepancies between the secondary clinician data and the clinician data. ### Claim 18 (depends on 15) The system of claim 15, wherein the report includes a display of, for a given point in time, both the clinician data and the AV data to thereby allow the secondary clinician to perform a quality review of the clinician data. ### Claim 19 (depends on 15) The system of claim 15, wherein the controller is configured to compare the patient reported data with patient reported data received at an earlier point in time and output a prompt to the patient to confirm that the patient intended for the patient reported data to be captured; and wherein the bio data and the patent reported data are associated with a time that the data was recorded and wherein the controller is configured to output the recommended course of action based on a difference in time between the bio data and the patient reported data. ### Claim 20 (depends on 15) The system of claim 15, wherein the controller is configured to provide an output that includes discrepancies between the patient reported data and the bio data.