Medication Nonadherence, "Professional Subjects," and Apparent Placebo Responders: Overlapping Challenges for Medications Development.

ABSTRACT: Nonadherence is a major problem in clinical trials of new medications. To evaluate the extent of nonadherence, this study evaluated pharmacokinetic sampling from 1765 subjects receiving active therapy across 8 psychiatric trials conducted between 2001 and 2011. With nonadherence defined as greater than 50% of plasma samples below the limit of quantification for study drug, the percentage of nonadherent subjects ranged from 12.8% to 39.2%. There was a trend toward increased nonadherence in studies with greater numbers of subjects, but an association with nonadherence was not apparent for other study design parameters or subject characteristics. For 2 trials with multiple recruitment sites in geographical proximity, several subjects attempted to simultaneously enroll at separate site locatio

SUBMITTER: McCann DJ 

PROVIDER: S-EPMC4553101 | biostudies-literature | 2015 Oct

REPOSITORIES: biostudies-literature