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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.

Addressing the Challenge of Patient Non-Compliance - Separating the Non-Compliers from the Non-Responders.

Published in Health & Medicine , Business
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  • 1. Addressing the Challenge of Patient Non-Compliance Non- Separating the Non-Compliers from the Non-Responders Non- Non-
  • 2. 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-compliance p p • Strategies for reducing non-compliance risk • What is the value for addressing this issue? • What are the industry obligations we face moving forward?
  • 3. 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 Care Haynes RB, DW (eds).
  • 4. There is No Excuse for Ignorance • “Keep watch also on the fault of patients which makes them lie about taking f thi t ki of things prescribed” ib d” Hippocrates, circa 500 BC • “Drugs don’t work if people don’t take them” C. Everett Koop, 1985 • I Ignoring th well-know i i the ll k issue of patient non-compliance or non- f ti t li 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, 2001 • 50 percent of patients are non-compliant • Boddenheimer & Fernandez, Ann Int Med, 2005 , ,
  • 5. 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 not meeting clinical criteria t Subjects t ti li i l it i 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 variance p
  • 6. 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 of these traditional practices are ineffective • Parking Lot Syndrome • Weekend/Holiday
  • 7. Why Non-Compliance?? • Lack of symptoms y p • Side effects • Unable to understand dosing instructions g – Complicated – Language/Translation issues • Forgetfulness – Generally accepted that blister cards provide a better opportunity for adherence – Calendar packs • Complicated multiple drug regimens
  • 8. Electronic Compliance Monitors Pros Cons • Smaller sample sizes or • Increased cost • Increased statistical power • Increased complexity – Greater confidence – Time • Quicker decision making • User acceptance • Quicker regulatory approval – What to do with the data • More accurate dosing information • Intra trial feedback • Positive ROI
  • 9. Mandating Electronic Compliance Monitoring • Will 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
  • 10. Adherence Data Can Increase Statistical Power • Resulting in positive ROI • Reliability is no longer an issue • Stricter co p a ce requirements may actua y St cte compliance equ e e ts ay actually reduce 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
  • 11. Sample Scenarios • Opiate analgesics – Reduce dependence liability p y – Reduce medico-legal liability – Increase clinical effectiveness • PRN medications; migraine medications 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
  • 12. Special Populations • Geriatric populations • Psychiatric populations • Addicted populations • Third-world populations • Poorly motivated populations – Where non adherence causes no symptoms non-adherence – Where non-adherence is catastrophic • Chronic indications where patients must take medication for long periods of time, e.g. diabetes, organ rejection
  • 13. Technology to Address Non-Compliance • Current and planned generations of electronic compliance monitors fit increasingly seamlessly into the trials process – High reliability – Patient friendly – no patient input required – User friendly – Highly flexible according to fit user requirements
  • 14. 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