IP Library Granted Patent US 11,056,216
Granted Patent B2
US 11,056,216 · App. 15/656,924 · Granted Jul 6, 2021

System for guiding clinical decisions using improved processing of data collected during a clinical trial

Inventors: Mark G. A. Opler (Hamilton, NJ); Sofija Jovic (Hamilton, NJ)
Assignee: MedAvante-ProPhase, Inc.
G16H10/20G16H10/60G16H50/20G16H15/00
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Quick Facts
Patent No.
US 11,056,216
App. No.
15/656,924
Granted
Jul 6, 2021
Kind
B2
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 (14)

1. 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 a condition of the patient participating in the clinical trial;

a bio sensor attached to the patient, wherein the bio sensor is configured to generate bio data representative of characteristics of the patient while the patient is participating in the clinical trial;

a video camera configured to capture audio/video (AV) data of the patient while the patient is participating in the clinical trial; and

a controller for processing data collected from the one of the group of patients, wherein the portable electronic device is operatively connected to the controller so that data can be transferred between the portable electronic 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 the bio data from the 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 AV data, the bio data, the patient reported data and the clinician data and produce 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; and

wherein the clinician data includes data related to an interaction of the clinician with the portable electronic device including revisions made to the clinician data by the clinician and an 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 a secondary clinician to perform a quality review of the clinician data.

2. The system of claim 1 , 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.

3. The system of claim 1 , wherein the display includes, 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.

4. The system of claim 1 , wherein the controller is configured to provide an output that includes discrepancies between the patient reported data and the bio data.

Assignments (7)
RELEASE OF SECURITY INTEREST IN INTELLECTUAL PROPERTY RECORDED AT REEL 071829 AND FRAME 0743 Recorded Mar 24, 2026
From: ALTER DOMUS (US) LLC
To: MEDAVANTE-PROPHASE, LLC; ANALGESIC SOLUTIONS LLC
Reel/Frame 075224/0015 →
SECURITY AGREEMENT (JOINDER) Recorded Jul 7, 2025
From: MEDAVANTE-PROPHASE, LLC; ANALGESIC SOLUTIONS LLC
To: ALTER DOMUS (US) LLC, AS COLLATERAL AGENT
Reel/Frame 071829/0743 →
RELEASE OF SECURITY INTEREST IN PATENTS Recorded May 2, 2025
From: BARCLAYS BANK PLC, AS COLLATERAL AGENT
To: MEDAVANTE-PROPHASE, LLC; ANALGESIC SOLUTIONS LLC
Reel/Frame 071161/0701 →
RELEASE OF SECURITY INTEREST Recorded May 2, 2025
From: WILMINGTON TRUST, NATIONAL ASSOCIATION
To: THREEWIRE, INC.; MEDAVANTE-PROPHASE, INC.; ANALGESIC SOLUTIONS LLC
Reel/Frame 071007/0474 →
SECURITY INTEREST Recorded Jan 8, 2020
From: THREEWIRE, INC.; MEDAVANTE-PROPHASE, INC.; ANALGESIC SOLUTIONS LLC
To: WILMINGTON TRUST, NATIONAL ASSOCIATION
Reel/Frame 051454/0322 →
FIRST LIEN PATENT SECURITY AGREEMENT Recorded Jan 8, 2020
From: ANALGESIC SOLUTIONS LLC; MEDAVANTE-PROPHASE, INC.; THREEWIRE, INC.
To: BARCLAYS BANK PLC, AS COLLATERAL AGENT
Reel/Frame 051504/0849 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 7, 2017
From: OPLER, MARK G.A.; JOVIC, SOFIJA
To: MEDAVANTE-PROPHASE, INC.
Reel/Frame 043809/0437 →
Continuity (2)
Provisional Application 62365122 · Jul 21, 2016
Related Publication 20180025133A1 · Jan 25, 2018
Cited By (1)
US 12,724,982