System for clinical trial subject compliance
DC CAFCFirst Claim
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1. A method for classifying results from one or more participants in a clinical trial, the method comprising:
- a. electronically accessing evaluability data obtained during the clinical trial, wherein the evaluability data is from the one or more participants in the clinical trial, wherein the evaluability data is stored on an electronic device, wherein the evaluability data comprise data from one or more evaluability data categories;
b. comparing the evaluability data from the one or more evaluability data categories to a norm to classify clinical trial results from each of the one or more participants in the clinical trial based on a type of compliance; and
c. analyzing the classified clinical trial results from the one or more participants with a similar type of compliance.
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Abstract
The present invention is designed to develop research protocols for clinical trials. The invention also can track and enhance subject compliance with a research protocol. The invention further provides evaluability data related to subject performance in the clinical trial. According to an alternative embodiment of the invention, a portable electronic device is used to query and collect data from the subject.
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Citations
63 Claims
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1. A method for classifying results from one or more participants in a clinical trial, the method comprising:
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a. electronically accessing evaluability data obtained during the clinical trial, wherein the evaluability data is from the one or more participants in the clinical trial, wherein the evaluability data is stored on an electronic device, wherein the evaluability data comprise data from one or more evaluability data categories; b. comparing the evaluability data from the one or more evaluability data categories to a norm to classify clinical trial results from each of the one or more participants in the clinical trial based on a type of compliance; and c. analyzing the classified clinical trial results from the one or more participants with a similar type of compliance. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21)
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22. A computer readable medium having stored thereon sequences of instructions, which, when executed by a computer system, cause the computer system to perform:
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a. electronically accessing evaluability data obtained during a clinical trial, wherein the evaluability data is from one or more participants in the clinical trial, wherein the evaluability data is stored on an electronic device, wherein the evaluability data comprise data from one or more evaluability data categories; b. comparing the evaluability data from the one or more evaluability data categories to a norm to classify clinical trial results from the one or more participants in the clinical trial based on a type of compliance; and c. analyzing the classified clinical trial results from the one or more participants with a similar type of compliance. - View Dependent Claims (23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42)
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- 43. A system comprising an electronic device for storing evaluability data obtained during a clinical trial, wherein the evaluability data is from one or more participants in the clinical trial, wherein the evaluability data comprise data from one or more evaluability data categories, wherein the electronic device can compare the evaluability data from the one or more participants in the clinical trial to a norm to classify clinical trial results from the one or more participants in the clinical trial based on a type of compliance, wherein the electronic device can analyze the classified clinical trial results from the one or more participants with a similar type of compliance.
Specification