Methods and systems for assessing clinical outcomes
AssigneeTheranos, Inc.
InventorsSeth Michelson, Timothy Michael Kemp, Ian Gibbons, Elizabeth A. Holmes
Life of this patent
Estimating the term…
Abstract
Described herein are methods and systems useful for characterizing clinical outcomes of a subject. Provided herein includes computer-assessed methods, medical information systems, and computer-readable instructions that can aid an end-user in diagnosis, prognosis, and treatment of a clinical outcome.
Claims30
A method for characterizing the probability of a clinical outcome of a subject, comprising:
- a. constructing one or more probability spaces with the aid of a computer processor that executes a program to construct said one or more probability spaces, wherein each probability space is defined by at least three discrete clinical outcomes, each discrete clinical outcome of said at least three discrete clinical outcomes is characterized by a statistical distribution of a set of biological marker(s), wherein the statistical distribution for a given set of biological marker(s) is different from all other statistical distributions for all other sets of biological markers characterizing each of the clinical outcomes within a given probability space, and wherein said given probability space is reflective of said at least three discrete clinical outcomes associated with a medical condition, medical procedure, therapy, clinical trial, drug discovery, or drug development;
- b. receiving, with the aid of a computer, subject data corresponding to the set of biological marker(s) for each discrete clinical outcome within the given probability space;
- c. calculating, with the aid of a computer processor that executes a program to determine the position of the subject data in the given probability space, the position of said subject data in said given probability space based on where said subject data falls within each statistical distribution of said set of biological marker(s) characterizing each said discrete clinical outcome;
- and
- d. repeating steps b) and c) at various time points to provide an output of a trajectory within said given probability space, wherein said trajectory is indicative of the likelihood of progression to one of said at least three discrete clinical outcomes.
A method of characterizing a clinical outcome of a subject comprising:
- a. constructing, with the aid of a computer processor within a server that executes a program to construct a probability space, the probability space defined by at least three discrete clinical outcomes, each discrete clinical outcome of said at least three discrete clinical outcomes is characterized by a statistical distribution of a set of biological marker(s), wherein the statistical distribution for a given set of biological marker(s) is different from all other statistical distributions for all other sets of biological markers characterizing each of the clinical outcomes within a given probability space, and wherein said given probability space is reflective of said at least three discrete clinical outcomes associated with a medical condition, medical procedure, therapy, clinical trial, drug discovery, or drug development;
- b. providing data of a subject to the server, said data corresponding to the set of biological marker(s) for each discrete clinical outcome within the given probability space;
- c. calculating, with the aid of a computer processor that executes a program to determine the position of the subject data in the given probability space, the position of said subject data in said given probability space based on where said subject data falls within the statistical distribution of said set of biological marker(s) characterizing each said discrete clinical outcome;
- and
- d. repeating steps b) and c) at various time points to provide an output of a trajectory within said given probability space, wherein said trajectory is indicative of the likelihood of progression to one of said at least three discrete clinical outcomes.
A medical information system for subject data analysis comprising:
- a. an input device for receiving subject data representing measurements of one or more biological markers;
- b. a computer processor in communication with said input device, wherein said computer processor
- i. constructs one or more probability spaces, each probability space defined by at least three discrete clinical outcomes, wherein each discrete clinical outcome of said at least three discrete clinical outcomes is characterized by a statistical distribution of a set of biological marker(s), wherein the statistical distribution for a given set of biological marker(s) is different from all other statistical distributions for all other sets of biological markers characterizing each of the clinical outcomes within a given probability space, wherein said given probability space is reflective of said at least three discrete clinical outcomes associated with a medical condition, medical procedure, therapy, clinical trial, drug discovery, or drug development;
- ii. calculates the position of said subject data in said given probability space based on where said subject data falls within each statistical distribution of said set of biological marker(s) characterizing each said discrete clinical outcome;
- and
- iii. calculates a trajectory within said given probability space, wherein said trajectory is indicative of the likelihood of progression to one of said at least three discrete clinical outcomes;
- c. an electronic storage unit in communication with the computer processor, said electronic storage unit having a database for:
- (i) storing data corresponding to said given probability space;
- and (ii) storing subject data corresponding to the at least one biological marker, said subject data representing measurements of said set of biological marker(s);
- d. an output device that transmits information relating to said one of said discrete clinical outcomes to an end user.
A medical information system for subject data analysis, comprising:
- a. a computer processor for executing computer readable instructions, which when executed by said processor implements a method comprising
- i. constructing one or more probability spaces with the aid of a computer processor that executes a program to construct said one or more probability spaces, wherein each probability space is defined by at least three discrete clinical outcomes, each discrete clinical outcome of said at least three discrete clinical outcomes is characterized by a statistical distribution of a set of biological marker(s), wherein the statistical distribution for a given set of biological marker(s) is different from all other statistical distributions for all other sets of biological markers characterizing each of the clinical outcomes within a given probability space, and wherein said given probability space is reflective of said at least three discrete clinical outcomes associated with a medical condition, medical procedure, therapy, clinical trial, drug discovery, or drug development;
- ii. receiving, with the aid of a computer, subject data corresponding to the set of biological marker(s) for each discrete clinical outcome within the given probability space;
- iii. calculating, with the aid of a computer processor that executes a program to determine the position of the subject data in the given probability space, the position of said subject data in said given probability space based on the probability that said subject data falls within each statistical distribution of said set of biological marker(s) characterizing each said discrete clinical outcome;
- and
- iv. repeating steps b) and c) at various time points to provide an output of a trajectory within said given probability space, wherein said trajectory is indicative of the likelihood of progression to one of said at least three discrete clinical outcomes
- b. a storage unit in communication with the computer processor, the storage unit having a database for:
- (i) storing data corresponding to said given probability space;
- and
- (ii) storing subject data corresponding to the set of biological marker(s).
A method for characterizing the probability of a clinical outcome of a subject, comprising:
- a. constructing one or more probability spaces with the aid of a computer processor that executes computer readable instructions for constructing said one or more probability spaces, wherein each probability space is defined by a plurality of discrete clinical outcomes, each discrete clinical outcome of said plurality is characterized by a statistical distribution of a set of biological marker(s), wherein a set of biological marker(s) characterizing a given statistical distribution within a given probability space is different from all other sets of biological marker(s) characterizing all other statistical distributions within said given probability space, and wherein said given probability space is reflective of the plurality of discrete clinical outcomes associated with a medical condition, medical procedure, therapy, clinical trial, drug discovery, or drug development;
- b. receiving, with the aid of a computer, subject data corresponding to the set of biological marker(s) for each discrete clinical outcome within the given probability space;
- c. calculating, with the aid of a computer processor that executes computer readable instructions to determine the position of the subject data in the given probability space, the position of said subject data in said given probability space based on where said subject data falls within each statistical distribution of said set of biological marker(s) characterizing each said discrete clinical outcome;
- and
- d. repeating steps b) and c) at various time points to provide an output of a trajectory within said given probability space, wherein said trajectory is indicative of the likelihood of progression to one of the plurality of discrete clinical outcomes.
Dependencies are inferred from the claim text.