Back to results
US 10,854,319 B2Granted
Systems and methods for visualizing clinical trial site performance
AssigneeAnalgesic Solutions
InventorsNathaniel P. Katz, Arturo J. Morales
Life of this patent
Estimating the term…
Abstract
Systems and methods for visualizing clinical trial site performance, or other multi-dimensional (or multi-parameter) datasets.
Claims16
A clinical monitoring system comprising:
- one or more memory units each operable to store at least one program;
- and
- at least one processor communicatively coupled to the one or more memory units, in which the at least one program, when executed by the at least one processor, causes the at least one processor to perform the operations of:
- monitoring clinical data, the clinical data representative of one or more characteristics of a respective clinical trial site, multiple clinical trial sites, a geographic region, and one or more clinical subjects;
- generating one or more clinical data points for a control chart based on the clinical data;
- applying a respective statistical process control (SPC) function to each of the clinical data to identify and distinguish non-random patterns from random patterns in the clinical data and generate a plurality of respective clinical data signals, wherein one of the respective clinical data signals is indicative of e-diary non-compliance, wherein one of the respective clinical data signals is indicative of study drug compliance, and wherein one of the respective clinical data signals is indicative of discordance between symptom scores;
- applying, using a rules engine, one or more rules to each of the clinical data signal, and determining whether one or more of the clinical data signal meets clinical trial threshold alert criteria;
- in response to determining that a respective clinical data signal meets clinical trial threshold alert criteria, wherein the clinical trial threshold alert criteria includes a criterion that is met when the SPC function identifies a non-random pattern in the clinical data:
- updating a user interface at a client device to identify a corresponding one or more clinical trial sites and/or clinical subjects and to cause an intervention at the corresponding clinical trial sites and/or clinical subjects, wherein the user interface includes an e-diary non-compliance control chart indicative of e-diary non-compliance, wherein one or more clinical data points of the e-diary non-compliance control chart are updated based on the one of the respective SPC function clinical data signals indicative of e-diary non-compliance, wherein the user interface includes a study drug compliance control chart indicative of study drug compliance, wherein one or more clinical data points of the study drug compliance control chart are updated based on the one of the respective SPC function clinical data signals indicative of study drug compliance, wherein the user interface includes a discordance between symptom scores control chart indicative of discordance between symptom scores, wherein one or more clinical data points of the discordance between symptom scores control chart are updated based on the one of the respective SPC function clinical data signals indicative of discordance between symptom scores;
- and
- in response to determining that the respective clinical data signal does not meet clinical trial threshold alert criteria:
- updating a user interface at a corresponding client device to visualize one or more representations of the clinical data signals.
9 more elements
A clinical monitoring method comprising:
- monitoring clinical data, the clinical data representative of one or more characteristics of a respective clinical trial site, multiple clinical trial sites, a geographic region, and one or more clinical subjects;
- generating one or more clinical data points for a control chart based on the clinical data;
- applying a respective statistical process control (SPC) function to each of the clinical data to identify and distinguish non-random patterns from random patterns in the clinical data and generate a plurality of respective clinical data signals, wherein one of the respective clinical data signals is indicative of e-diary non-compliance, wherein one of the respective clinical data signals is indicative of study drug compliance, and wherein one of the respective clinical data signals is indicative of discordance between symptom scores;
- applying, using a rules engine, one or more rules to each of the clinical data signal, and determining whether one or more of the clinical data signal meets clinical trial threshold alert criteria;
- in response to determining that a respective clinical data signal meets clinical trial threshold alert criteria, wherein the clinical trial threshold alert criteria includes a criterion that is met when the SPC function identifies a non-random pattern in the clinical data:
- updating a user interface at a client device to identify a corresponding one or more clinical trial sites and/or clinical subjects and to cause an intervention at the corresponding clinical trial sites and/or clinical subjects, wherein the user interface includes an e-diary non-compliance control chart indicative of e-diary non-compliance, wherein one or more clinical data points of the e-diary non-compliance control chart are updated based on the one of the respective SPC function clinical data signals indicative of e-diary non-compliance, wherein the user interface includes a study drug compliance control chart indicative of study drug compliance, wherein one or more clinical data points of the study drug compliance control chart are updated based on the one of the respective SPC function clinical data signals indicative of study drug non-compliance, wherein the user interface includes a discordance between symptom scores control chart indicative of discordance between symptom scores, wherein one or more clinical data points of the discordance between symptom scores control chart are updated based on the one of the respective SPC function clinical data signals indicative of discordance between symptom scores;
- and
- in response to determining that the respective clinical data signal does not meet clinical trial threshold alert criteria:
- updating a user interface at a corresponding client device to visualize one or more representations of the clinical data signals.
6 more elements
Dependencies are inferred from the claim text.