Method and Apparatus for Verification of Clinical Trial Adherence

a clinical trial and verification method technology, applied in the field of patient compliance in clinical drug trials, can solve problems such as personal liability

Inactive Publication Date: 2011-06-23
AI CURE TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0019]In accordance with the present invention, a system and method are provided that allow for complete control and verification of adherence to a prescribed medication protocol or machine or apparatus use in a clinical trial setting, whether in a health care provider's care, or when self administered in a homecare situation by a patient.

Problems solved by technology

Failure may result in personal liability.

Method used

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  • Method and Apparatus for Verification of Clinical Trial Adherence
  • Method and Apparatus for Verification of Clinical Trial Adherence
  • Method and Apparatus for Verification of Clinical Trial Adherence

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Embodiment Construction

[0037]In accordance with the invention, a system and process are provided that improve adherence to medical protocol in a clinical trial setting, and give administrators a tangible and concrete manner in which to confirm compliance or lack thereof, and the ability to intervene early in the process to ensure that patients enrolled in such a clinical trial study are properly taking their medication. The system and method of the invention provide for instructions to patients on the use of the prescription medication under trial, verification to a doctor or other service provider of patient adherence to the prescribed protocol, and statistical and individual analysis of adherence rates to ensure proper clinical trial administration. The system and method further improve a level of care received by a patient in a clinical trial, and other setting, as well as improve the perception of that level of care by the patient. The system and method of the invention further provide the ability to ...

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PUM

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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.

Description

FIELD OF THE INVENTION[0001]This invention relates generally to patient compliance in clinical drug trials and more particularly to the monitoring, instruction and intervention of patients in clinical trials in order to improve compliance with required drug protocols in accordance with those trials.BACKGROUND OF THE INVENTION[0002]Dr Lars Osterberg, M.D. and Dr, Terence Blaschke have reported in the New England Journal of Medicine, Adherence to Medication, (N Engl J Med 2005; 353:487-97) 2005 an alarming lack of adherence to required medication protocol, further noting that while the average rates of adherence in clinical trials is categorized as “high”, this number still comprises only rates of 43 to 78 percent. Most importantly, the authors note “The ability of physicians to recognize nonadherence is poor, and interventions to improve adherence have had mixed results.”Adherence, p. 487. The authors conclude “Poor adherence to medication regimens is common, contributing to substant...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): G06Q50/00G06Q10/00G06F17/30G16H10/60
CPCG06Q10/10G06Q50/22G06K9/00335G06F19/3456G06Q50/24G16H10/20G16H20/10G16H20/60G16H10/60G06V20/48G06V40/20G06T7/0012
Inventor HANINA, ADAMKESSLER, GORDON
Owner AI CURE TECH
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