Method and apparatus for verification of clinical trial adherence
First Claim
1. A method of confirming administration of medication in a clinical trial, comprising the steps of:
- identifying a particular medication prescription regimen in accordance with the clinical trial;
predefining one or more identifiable gestures indicative of ingestion of the medication in accordance with the medication prescription regimen for the clinical trial;
providing on a display of a local device one or more instruction prompts directing performance of the one or more predefined identifiable gestures indicative of proper ingestion of the medication;
capturing video activity sequences by the local device of actual medication ingestion following the one or more instruction prompts directing performance of the one or more predefined identifiable gestures indicative of proper ingestion of the medication by a video capture device;
storing the captured video activity sequences to a non-transitory computer readable storage medium of the local device;
comparing the stored video activity sequences to the predefined one or more gestures indicative of ingestion of the medication by a computer processor of the local device;
determining differences between the stored video activity sequences and the predefined one or more gestures indicative of ingestion of the medication by the computer processor of the local device, indicating proper ingestion of the medication has failed;
providing on the display of the local device, in real time in response to the determined differences, one or more further instruction prompts for further directing current performance of the one or more predefined identifiable gestures indicative of proper ingestion of the medication;
capturing second video activity sequences by the local device of actual medication ingestion following the one or more further instruction prompts by the video capture device;
storing the second captured video activity sequences to the non-transitory computer readable storage medium of the local device;
comparing the second stored video activity sequences to the predefined one or more gestures indicative of ingestion of the medication by a computer processor of the local device; and
determining there are no differences between the second stored video activity sequences and the predefined one or more gestures indicative of ingestion of the medication by the computer processor of the local device.
2 Assignments
0 Petitions
Accused Products
Abstract
A system and method of confirming administration of medication in a clinical trial is provided. The method comprises the steps of receiving information identifying a particular medication prescription regimen in accordance with the clinical trial, determining one or more procedures for administering such prescription regimen and identifying one or more activity sequences associated with such procedures. Activity sequences of actual administration of such prescription regimen are captured and then compared to the identified activity sequences to determine differences therebetween. A notice is provided if differences are determined.
-
Citations
24 Claims
-
1. A method of confirming administration of medication in a clinical trial, comprising the steps of:
-
identifying a particular medication prescription regimen in accordance with the clinical trial; predefining one or more identifiable gestures indicative of ingestion of the medication in accordance with the medication prescription regimen for the clinical trial; providing on a display of a local device one or more instruction prompts directing performance of the one or more predefined identifiable gestures indicative of proper ingestion of the medication; capturing video activity sequences by the local device of actual medication ingestion following the one or more instruction prompts directing performance of the one or more predefined identifiable gestures indicative of proper ingestion of the medication by a video capture device; storing the captured video activity sequences to a non-transitory computer readable storage medium of the local device; comparing the stored video activity sequences to the predefined one or more gestures indicative of ingestion of the medication by a computer processor of the local device; determining differences between the stored video activity sequences and the predefined one or more gestures indicative of ingestion of the medication by the computer processor of the local device, indicating proper ingestion of the medication has failed; providing on the display of the local device, in real time in response to the determined differences, one or more further instruction prompts for further directing current performance of the one or more predefined identifiable gestures indicative of proper ingestion of the medication; capturing second video activity sequences by the local device of actual medication ingestion following the one or more further instruction prompts by the video capture device; storing the second captured video activity sequences to the non-transitory computer readable storage medium of the local device; comparing the second stored video activity sequences to the predefined one or more gestures indicative of ingestion of the medication by a computer processor of the local device; and determining there are no differences between the second stored video activity sequences and the predefined one or more gestures indicative of ingestion of the medication by the computer processor of the local device. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 22)
-
-
11. A system for confirming administration of medication in a clinical trial, comprising:
-
an authentication apparatus for authenticating a clinical trial manager; an input device for receiving information identifying a particular medication prescription regimen from the authenticated clinical trial manager; a storage device storing prescription administration information associated with the identified medication prescription regimen subject to the clinical trial, a predefined set of one or more identifiable gestures indicative of proper ingestion of medication in accordance with which the prescription regimen is to be administered, and one or more instruction prompts directing performance of the one or more predefined identifiable gestures indicative of proper ingestion of the medication; a video capture device for providing on an associated output device the one or more instruction prompts directing performance of the one or more predefined identifiable gestures indicative of proper ingestion of the medication; a processor locally associated with the video capture device configured to perform the steps of; capturing video activity sequences with the video capture device of actual medication ingestion following the one or more instruction prompts directing performance of the one or more predefined identifiable gestures indicative of proper ingestion of the medication; storing the captured video sequences to a storage medium locally associated with the video capture device; comparing the stored video activity sequences to the predefined one or more gestures indicative of ingestion of the medication; determining by the processor that the stored captured video sequences are different from the one or more predefined identifiable gestures indicative of ingestion of the medication, indicating proper ingestion of the medication has failed; causing the output device associated with the video capture device to provide, in response to the determined differences in real time, one or more further instruction prompts for further directing current performance of the one or more predefined identifiable gestures indicative of proper ingestion of the medication; capturing second video activity sequences with the video capture device of actual medication ingestion following the further instruction prompts; storing the second captured video sequences to a storage medium locally associated with the video capture device; comparing the stored second video activity sequences to the predefined one or more gestures indicative of ingestion of the medication; and determining by the processor that the stored second captured video sequences are different from the one or more predefined identifiable gestures indicative of ingestion of the medication, indicating proper ingestion of the medication was successful. - View Dependent Claims (12, 13, 23)
-
-
14. A method of confirming administration ingestion of medication in a clinical trial, comprising the steps of:
-
authenticating a prescribing clinical trial manager; receiving information identifying a particular medication ingestion regimen from the authenticated clinical trial manager; modifying the medication ingestion regimen, if necessary, by the authenticated clinical trial manager; providing on a display of a local device one or more instruction prompts directing performance of one or more predefined identifiable gestures comprising visual indicia indicative of proper ingestion of the medication; capturing appropriate visual indicia by the local device of actual medication ingestion following the one or more instruction prompts directing performance of the one or more predefined identifiable gestures indicative of proper ingestion of the medication; storing the captured visual indicia to a non-transitory computer readable storage medium of the local device; comparing by a computer processor associated with the local device the captured indicia for determining confirmation of medication ingestion to the one or more predefined identifiable gestures indicative of proper ingestion of the medication; determining differences between the captured indicia and the predefined identifiable gestures; providing, in real time in response to one or more determined differences a notice via the display of the local device, one or more further instruction prompts for further directing current performance of the one or more predefined identifiable gestures indicative of proper medication ingestion; capturing appropriate second visual indicia by the local device of actual medication ingestion following the one or more further instruction prompts; storing the captured second visual indicia to a non-transitory computer readable storage medium of the local device; comparing by a computer processor associated with the local device the captured second visual indicia for determining confirmation of medication ingestion to the one or more predefined identifiable gestures indicative of proper ingestion of the medication; and determining there are no differences between the captured indicia and the predefined identifiable gestures. - View Dependent Claims (15, 16, 17, 18, 19, 20, 21, 24)
-
Specification