Method and Apparatus for Verification of Clinical Trial Adherence

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.

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.   
     
     
         2 . The method of  claim 1 , wherein the prescription regimen is provided by a clinical trial manager. 
     
     
         3 . The method of  claim 1 , wherein the prescription regimen and procedures for administering the prescription are retrieved from a medical database. 
     
     
         4 . The method of  claim 1 , further comprising the step of performing a statistical analysis of differences determined in the comparing step. 
     
     
         5 . The method of  claim 1 , further comprising the steps of:
 retrieving medical history information of a patient to receive the administered medication subject to the clinical trial; and   confirming that the administered medication is safe for the patient.   
     
     
         6 . The method of  claim 1 , further comprising the steps of:
 before capturing the one or more activity sequences of administration of the prescription regimen, determining the identity of a particular medication to be used in such administration; and   issuing a warning if it is determined that the determined identity is not the medication associated with the upcoming prescription regimen.   
     
     
         7 . The method of  claim 1 , further comprising the steps of:
 capturing activity sequences of actual administration of the prescription regimen during multiple instances of administration;   comparing the captured activity sequences to the identified video sequences to determine differences therebetween; and   providing an analysis of adherence to a particular prescription regimen in accordance with the multiple instances of administration.   
     
     
         8 . The method of  claim 7 , further comprising the step of providing additional instructions to a medication administrator in accordance with the provided analysis. 
     
     
         9 . The method of  claim 1 , wherein the notice comprises live contact with a clinical trial manager. 
     
     
         10 . The method of  claim 1 , wherein the notice comprises additional instructions to a patient receiving the medication according to the one or more procedures of the clinical trial. 
     
     
         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 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.   
     
     
         12 . The system of  claim 11 , wherein the information stored on the storage device may be modified by the authenticated clinical trial manager. 
     
     
         13 . The system of  claim 11 , wherein the capture device is further adapted to capture images of a particular medication to allow identification thereof. 
     
     
         14 . A method of confirming administration of medication in a clinical trial, comprising the steps of:
 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.   
     
     
         15 . The method of  claim 14 , wherein the indicia for determining confirmation of prescription administration comprises one or more activity sequences. 
     
     
         16 . The method of  claim 15 , wherein the indicia for determining confirmation of prescription administration comprises an alternative method when activity sequences may not be recorded. 
     
     
         17 . The method of  claim 14 , further comprising the steps of:
 capturing indicia of activity of a patient before medication administration; and   providing a reminder to the patient at least in part in accordance with the captured indicia before medication administration.   
     
     
         18 . The method of  claim 14 , further comprising the step of capturing indicia of activity of a patient before medication administration, wherein the captured indicia before medication administration comprises evidence of patient consent. 
     
     
         19 . The method of  claim 14 , further comprising the steps of:
 capturing indicia of activity of a patient after medication administration;   providing notification to a medical service provider of the activity; and   modifying at least one aspect of a prescription regimen in accordance with the captured indicia after medication administration.   
     
     
         20 . The method of claim  26 , wherein the captured indicia after medication administration comprises an adverse reaction to the medication. 
     
     
         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.