Methods for conducting studies
OwnerRichard Keefe, Vicki Davis +3inventors
InventorsRichard Keefe, Vicki Davis, Michael Hufford, Nicole Turcotte, Jenna Piunti
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Abstract
Provided herein are methods, devices, systems, and computer readable medium for improving studies such as clinical trials and for improving clinical practice. The methods, devices, systems, and computer readable medium provided herein can be used to identify outlier data in a study, select data collection sites likely to produce high quality data, detect fraud, identify placebo responders, and/or identify likely responders to a therapy. The methods, devices, systems, and computer readable medium provided herein can also be used to optimize a test, for example, a neurocognitive battery, for maximum sensitivity.
Claims26
A method of performing a study, the method comprising acquiring a first set of data comprising one or more responses to one or more assessments administered to a subject;
- comparing the first set of data from the subject to a second set of data, wherein the comparing comprises execution of an algorithm on an electronic device;
- generating a fraud index based on the comparing, wherein the fraud index indicates the probability that the first set of data comprises fraudulent data;
- determining the presence or absence of fraudulent data based on the fraud index;
- and
- modifying the first set of data if fraudulent data is present in the first set of data.
16-131. (canceled)
A method of performing a study, the method comprising
- obtaining data concerning the performance of one or more data collection sites in conducting one or more studies;
- obtaining information regarding one or more additional features of the one or more data collection sites;
- analyzing the information and data, wherein the analyzing comprises executing an algorithm on an electronic device;
- generating a site quality index based on the analyzing, wherein the site quality index provides an indication of quality of the one or more data collection sites;
- and
- selecting or excluding one or more data collection sites from a study based on the site quality index.
-228. (canceled)
A method for performing a study, the method comprising
- acquiring a first set of data, wherein the first set of data comprises one or more responses to one or more assessments administered to a subject;
- comparing the first set of data to a second set of data, wherein the comparing comprises execution of an algorithm on an electronic device;
- determining a data outlier index based on the comparing;
- and
- modifying the first set of data based on the data outlier index.
230-381. (canceled)
A method of treating a subject with a condition, the method comprising
- administering one or more tests to the subject;
- comparing scores from the one or more tests to scores from the one or more tests from one or more other subjects;
- generating a responder index based on the comparing, wherein the responder index quantifies the probability that the subject will show an improvement to one or more therapies, wherein the generating comprises executing an algorithm on an electronic device;
- comparing the responder index to a threshold;
- determining whether the subject is a likely responder based on d);
- and
- enrolling or not enrolling the subject in the clinical trial based on e).
383-434. (canceled)
A method of performing a study for a condition, the method comprising
- acquiring a first set of data, wherein the first set of data comprises one or more responses to one or more assessments administered to a subject;
- acquiring additional information about the subject;
- generating a placebo responder index based on the first set of data and the information, wherein the placebo responder index is generated by executing an algorithm on an electronic device;
- and
- modifying the study based on a likelihood the subject will respond to placebo.
436-496. (canceled)
A method of generating an optimized neurocognitive battery, the method comprising
- administering one or more neurocognitive batteries to a plurality of subjects with a neurocognitive condition;
- creating a database of results of the one or more neurocognitive batteries;
- analyzing the database by executing an algorithm on an electronic device;
- and
- identifying an optimized neurocognitive battery based on the analyzing.
498-526. (canceled)
Dependencies are inferred from the claim text.