addressing the challenge of patient non complaince
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Addressing the Challenge of Patient Non-Compliance - Separating the Non-Compliers from the Non-Responders.TRANSCRIPT
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Addressing the Challenge of Patient NonAddressing the Challenge of Patient Non--ComplianceCompliance
Separating the NonSeparating the Non--Compliers from the NonCompliers from the Non--RespondersResponders
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Today’s Topic: Patient Non-Compliance
• Discover the population profiles for non-compliance• Reveal the underlying reasons – symptomatic versus
asymptomatic patients• The implications of non-compliancep p• Strategies for reducing non-compliance risk• What is the value for addressing this issue?• What are the industry obligations we face moving forward?• What are the industry obligations we face moving forward?
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What Do We Mean by Non-Compliance?
Non-compliance is the degree to which behavior fails to coincide
with medical recommendations in …taking medication, attending
clinical appointments, following exercise or diet regimens and
engaging in preventative behavior*
*Haynes RB Taylor DW Sackett DL (eds) Compliance in Health CareHaynes RB, Taylor DW, Sackett DL (eds). Compliance in Health Care
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There is No Excuse for Ignorance
• “Keep watch also on the fault of patients which makes them lie about t ki f thi ib d”taking of things prescribed” Hippocrates, circa 500 BC
• “Drugs don’t work if people don’t take them” C. Everett Koop, 1985
I i th ll k i f ti t li• Ignoring the well-know issue of patient non-compliance or non-adherence makes no sense, especially when it is simple to turn a liability into an asset
• Estimated annual cost to the US Health Care System of non-compliance with prescribed medication over $175B
• Ernst & Grizzle, JAPharmA, 2001Ernst & Grizzle, JAPharmA, 2001
• 50 percent of patients are non-compliant
• Boddenheimer & Fernandez, Ann Int Med, 2005, ,
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Non-Compliance in the Clinical Trial Setting
• Results of non-compliance include: – Loss of subjects to follow up– Loss of patients to side effects
S bj t t ti li i l it i t– Subjects not meeting clinical criteria to continue in the study
– Injection of error variance into the study
– Failure to complete the study with enough participants to produce statistically significant results
– Requirement to increase sample sizes to compensate for error variancep
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How do you Ensure Non-Adherence is not Undermining your Data?
• Traditional approaches to addressing non-compliance
– Patient self reports– Medication diaries– Tablet counts– Monitoring plasma levels
Electronic compliance data show that many• Electronic compliance data show that many of these traditional practices are ineffective
• Parking Lot Syndrome• Weekend/Holiday
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Why Non-Compliance??
• Lack of symptomsy p
• Side effects
• Unable to understand dosing instructionsg
– Complicated
– Language/Translation issues
• Forgetfulness
– Generally accepted that blister cards provide a better opportunity for adherence
– Calendar packs
• Complicated multiple drug regimens• Complicated multiple drug regimens
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Electronic Compliance Monitors
Pros Cons• Smaller sample sizes or• Increased statistical power
– Greater confidence
• Increased cost• Increased complexity
– TimeGreater confidence
• Quicker decision making• Quicker regulatory approval
Time
• User acceptance– What to do with the data
• More accurate dosing information
• Intra trial feedback• Positive ROI
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Mandating Electronic Compliance Monitoring
• Will the FDA issue a mandate as theseWill the FDA issue a mandate as these devices become cost effective and reliable?
• Case Study: NIH sponsored a trial
– Regimen of 1x day for one year
– COPD population
– Made the assumption that this type of trial would typically be plagued with non-compliance
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Adherence Data Can Increase Statistical Power
• Resulting in positive ROIResulting in positive ROI
• Reliability is no longer an issue
• Stricter compliance requirements may actually St cte co p a ce equ e e ts ay actua yreduce the N for a trial
• Sample training
• Intra-trial feedback
• Adjusting trial data post hoc for non compliance
• Better correlation of drug/Adverse Events
• More accurate dosing information
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Sample Scenarios
• Opiate analgesics– Reduce dependence liabilityp y– Reduce medico-legal liability– Increase clinical effectiveness
• PRN medications; migraine medications• PRN medications; migraine medications, sleep medication
• Critical window drugs– Combination therapies, e.g. HIV,
chemotherapies– High toxicity drugs
• Mandated pharmacotherapy, e.g. cyproterone, naltrexone, INH
• Combination therapies, e.g. HIV, chemotherapies
– High toxicity drugs
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Special Populations
• Geriatric populationsGeriatric populations• Psychiatric populations• Addicted populations• Third-world populations• Poorly motivated populations
Where non adherence causes no symptoms– Where non-adherence causes no symptoms– Where non-adherence is catastrophic
• Chronic indications where patients must take medication for long periods of time, e.g. diabetes, organ rejection
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Technology to Address Non-Compliance
• Current and planned generations ofCurrent and planned generations of electronic compliance monitors fit increasingly seamlessly into the trials process
– High reliability
– Patient friendly – no patient input requiredrequired
– User friendly
– Highly flexible according to fit user requirements
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Three Practical Recommendations for Sponsors Today
• When considering electronic compliance, early involvement from the technical team is critical
• Have a strategy for using the data
• Old paradigms no longer apply