US 12,266,428 B2
System and method for determining subject conditions in mobile health clinical trials
David Lee, New York, NY (US); Kara Dennis, New York, NY (US); and John Savage, Fair Haven, NJ (US)
Assigned to MEDIDATA SOLUTIONS, INC., New York, NY (US)
Filed by MEDIDATA SOLUTIONS, INC., New York, NY (US)
Filed on Sep. 22, 2023, as Appl. No. 18/473,009.
Application 18/473,009 is a division of application No. 14/630,259, filed on Feb. 24, 2015, granted, now 11,804,287.
Claims priority of provisional application 62/080,075, filed on Nov. 14, 2014.
Prior Publication US 2024/0013872 A1, Jan. 11, 2024
This patent is subject to a terminal disclaimer.
Int. Cl. G16H 10/20 (2018.01); G06N 5/04 (2023.01); G06N 20/00 (2019.01); G16H 50/20 (2018.01)
CPC G16H 10/20 (2018.01) [G06N 5/04 (2013.01); G06N 20/00 (2019.01); G16H 50/20 (2018.01)] 9 Claims
OG exemplary drawing
 
1. A computer-implemented method comprising:
receiving data during time intervals from a plurality of mobile health sensors, including sensors within a single device or multiple devices;
receiving a diary that records subject state determinations;
integrating the data from the mobile health sensors and the subject state determinations from the diary;
cleaning the integrated data;
determining which variables optimally predict the subject state;
partitioning said integrated and cleaned data using a combination of ranges of values for the variables that optimally predict the subject state;
generating a training set of data comprising a portion of the integrated, cleaned, and partitioned data;
training a predictive model using the training set and a machine learning algorithm; and
generating the predictive model of the state of the subject of the clinical trial based on the training set; and
using the predictive model to determine subject state for data without the diary that records said subject state determination,
wherein the subject state comprises a digital bio-marker for a disease condition, and wherein to determine the ranges of the values for the variables that optimally predict the subject state, the method further comprises:
(a) for a first variable X1, using a range of data, X1>A, where A is a defined value, to classify the data according to a first state Y1 and a second state Y2;
(b) computing a ratio between Y1 and Y2, or between Y1 and Y1+Y2, for data where X1 is not greater than A and for data where X1 is greater than A, respectively; and
iteratively repeating (a) and (b) for selected values of A to maximize said ratio between Y1 and Y2, or between Y1 and Y1+Y2.