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;
determining one or more procedures for administering such prescription regimen in accordance with the clinical trial;
identifying one or more activity sequences associated with such procedures;
capturing activity sequences of actual administration of such prescription regimen;
comparing the captured activity sequences to the identified activity sequences to determine differences therebetween; and
providing a notice if differences are determined.
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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.
156 Citations
21 Claims
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1. A method of confirming administration of medication in a clinical trial, comprising the steps of:
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identifying a particular medication prescription regimen in accordance with the clinical trial; determining one or more procedures for administering such prescription regimen in accordance with the clinical trial; identifying one or more activity sequences associated with such procedures; capturing activity sequences of actual administration of such prescription regimen; comparing the captured activity sequences to the identified activity sequences to determine differences therebetween; and providing a notice if differences are determined. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A system for confirming administration of medication in a clinical trial, comprising:
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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 database comprising prescription administration information for the medication subject to the clinical trial, a storage device for storing prescription administration selected from the database and being associated with the identified medication prescription subject to the clinical trial, a set of instructions in accordance with which the prescription regimen is to be administered, and one or more activity sequences associated with such instructions; a capture device for capturing activity sequences of actual administration of such prescription regimen over a plurality of administrations of the prescription regimen; a processor for comparing the captured activity sequences to the identified activity sequences to determine differences therebetween; and an output device for providing an immediate notice if differences are determined in the comparing step that may place a patient receiving the prescription regimen in danger; and
for providing a notice if differences are determined in the comparing step that may improve future administration of the prescription regimen in the clinical trial. - View Dependent Claims (12, 13)
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14. A method of confirming administration of medication in a clinical trial, comprising the steps of:
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authenticating a prescribing clinical trial manager; receiving information identifying a particular medication prescription regimen from the authenticated clinical trial manager; determining one or more procedures for administering such prescription regimen from one or more databases including prescription regimen information in accordance with prescription information provided by the authenticated clinical trial manager; modifying the procedures, if necessary, by the authenticated clinical trial manager; providing a set of instructions in accordance with which the prescription regimen is to be administered; identifying one or more indicia for determining confirmation of prescription administration associated with such instructions; capturing appropriate indicia of actual administration of such prescription regimen over a plurality of administrations of the prescription regimen; comparing the captured indicia for determining confirmation of prescription administration to the identified indicia for determining confirmation of prescription administration to determine differences therebetween; providing an immediate notice if differences are determined in the comparing step that may place a patient receiving the prescription regimen in danger; and providing a notice if differences are determined in the comparing step that may improve future administration of the prescription regimen in the clinical trial. - View Dependent Claims (15, 16, 17, 18, 19)
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20. The method of claim 26, wherein the captured indicia after medication administration comprises an adverse reaction to the medication.
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21. The method of claim 21, further comprising the step of determining payments to a patient in a clinical trial based upon their level of compliance to the prescribed regimen in the clinical trial.
Specification