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

, : Medication Nonadherence, "Professional Subjects," and Apparent Placebo Responders: Overlapping Challenges for Medications Development. Journal of Clinical Psychopharmacology 35(5): 566-573

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 locations. The construct of "professional subjects," those who enroll in trials only for financial gain, is gaining attention, and we therefore modeled the impact of professional subjects on medication efficacy trials. The results indicate that enrollment of professional subjects who are destined to succeed (those who will appear to achieve treatment success regardless of study drug assignment) can substantially increase both the apparent placebo response rate and the sample size requirement for statistical power, while decreasing the observed effect size. The overlapping nature of nonadherence, professional subjects, and placebo response suggests that these issues should be considered and addressed together. Following this approach, we describe a novel clinical trial design to minimize the adverse effects of professional subjects on trial outcomes and discuss methods to monitor adherence.


PMID: 26244381

DOI: 10.1097/JCP.0000000000000372

Other references

Fenstad, A.M., 1995: Treatment of external resorption. A report of two cases. Northwest Dentistry 74(4): 27-28

Almeida, J.G. de, 2004: Geometric characterization of bamboos for construction and object manufacture: comparative analysis of the Guadua weberbaueri and the Phyllostachys bambusoides. Two bamboo species were compared, one is a native bamboo (Guadua weberbaueri), and the other is a cultivated bamboo (Phyllostachys bambusoides). The analysis considers as the main variable the culm shape, i.e., morphological or geometrical charact...

Meer, C.L.J. van der; Strijker, D., 1986: The future development of agricultural land use in the Netherlands. Two exploratory studies were done at the request of the Dutch Planning Service into the future development of agricultural land use in the Netherlands. The first discusses the long-term development of production, land use and land productivity in...

Irgasheva M.K.; Gitsu G.A.; Miriev K.I., 1970: Study of the effectiveness of thiabendazole in human hookworm disease. Meditsinskaya Parazitologiya i Parazitarnye Bolezni 39(4): 414-416

Lukacs, J., 1987: A product-line approach to nursing services. Nurse Practitioner 12(12): 48, 50, 52-48, 50, 52

Hartley, W.J.; Jebson, J.L.; Mcfarlane, D., 1954: The artificial infection of sheep with a brucella-like organism. I. The artificial infection of ewes. After a flock of 147 ewes had been with rams for about 3 weeks the authors infected 115 of them with 106 or 108 brucella-like organ-isms from the semen of a ram with epididymitis. The remaining 32 ewes served as controls. Abortions began at the 48...

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Staley, J.K.; Mash, D.C.; Parsons, S.M.; Khare, A.B.; Efange, S.M., 1998: Pharmacological characterization of the vesamicol analogue (+)-[(125)I]MIBT in primate brain. The vesamicol analogue, meta-[(125)I]iodobenzyltrozamicol [(+)-[(125)I]MIBT] was evaluated as a probe for the in vitro labeling of the vesicular acetylcholine transporter in primate brain. In the striatum, (+)-[(125)I]MIBT bound a single high-affi...

Chiang, O., E.; Quinones, R., A., 2007: Relationship between viral and prokaryotic abundance on the Bajo O'Higgins 1 seamount (Humboldt Current System off Chile). There is little known about the ecology of microbial communities living in the water column over seamounts. Here, for the first time, the spatial distribution and abundance of virus-like particles (VLP) are described over a seamount. The associat...