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Meant to include a link to the paper at NEJM:
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Here is one more for the list of challenges with regard to the impact of compliance on clinical trials. Osterberg and Blaschke published in NEJM that even in clinical trials, average adherence rates for chronic therapies are reported in the range of 43-78%. One potential problem is that we then do an intent-to-treat analysis on all patients in the study, and use this data to report (and label) product efficacy and safety. So if you are a patient who is 100% compliant and take the drug every day, are you "over-dosing" compared to the average patient in the clinical trial (who was, on average, only exposed to half to three-quarters of the drug doses)? Another challenge in interpreting averages from large studies to draw conclusions about individual patient outcomes?
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Jul 9, 2010