Electronic Compliance Monitoring

Using Electronic Compliance Monitoring (ECM) in the drug development process Ward Smith Clinical Packaging Consultant [email_address] 513-307-8163

Disclaimer ,[object Object],[object Object],[object Object]

Overview ,[object Object],[object Object],[object Object],[object Object],[object Object]

WHAT is electronic compliance monitoring (ECM)? ,[object Object],[object Object],(Non-pharma ECM)

Concept started 33 years ago ,[object Object],[object Object]

1976 $500 each ($1200 today) 6 weeks of data

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HOW does it work? ,[object Object]

Data Capturing Options Multiple wireless methods

Daily 24 hour clock Sequential dosing days Chronology of Dosage: Desirable Example of near perfect compliance

Chronology of Dosage: Reality Increasing timing variation Multi-day dosing holiday

Why us ECM? . ,[object Object],[object Object],[object Object],[object Object]

Unreliable subjects are well documented.

Not all patients report Non-adherence data ,[object Object],[object Object],[object Object],[object Object]

Where is ECM data useful? ,[object Object],[object Object],[object Object],[object Object]

Case: Kuopio University Hospital Opioid Substitution Treatment ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Case: Kuopio University Hospital Reduction in treatment costs of nearly 40% ,[object Object],[object Object],[object Object],[object Object]

Prevent Post-marketing dose reductions Sub-optimal adherence is a serious problem in Intent To Treat studies that can lead to the failure of the trial Both papers show that 1 drug in 4.5 has had at least a 50% fall in recommended dose since 1980 (excluding antimicrobial drugs) Incidence of post market dose reduction is rising ,[object Object],[object Object],“ Maximum Tolerated Dose” rather than “Minimal Effective Dose” Most drugs are overdosed to « pass » ITT High risk of dose reduction, and thus revenue reduction once on the market

NHS is using ECM ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

When should you start planning? EARLY!!! ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

When should you start planning? EARLY!!! ,[object Object],[object Object],[object Object]

Who are some ECM solution providers? ,[object Object],[object Object],[object Object],[object Object]

[object Object],[object Object],[object Object],[object Object],[object Object],Conclusion Ward Smith Clinical Packaging Consultant [email_address] 513-307-8163

Electronic Compliance Monitoring

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