ReviewJournal of clinical psychopharmacology2015
Medication Nonadherence, "Professional Subjects," and Apparent Placebo Responders: Overlapping Challenges for Medications Development.
Review in Journal of clinical psychopharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
32 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Placebo Response in Trials of Negative Symptoms in Schizophrenia: A Critical Reassessment of the Evidence.Schizophrenia bulletin · 2022Pooled it
- Neuropathic pain clinical trials: factors associated with decreases in estimated drug efficacy.Pain · 2018Pooled it
- Addressing Disturbance in Bodily Experience After Ventricular Assist Device Implantation: A Multicenter Randomized Controlled Trial of Curricular Psychological Support.Artificial organs · 2025Trial
- Results of a randomized, double-blind, placebo-controlled trial of lorcaserin in cocaine use disorder.Drug and alcohol dependence · 2024Trial
- Evaluation of a plasticity-based cognitive training program in schizophrenia: Results from the eCaesar trial.Schizophrenia research · 2019Trial
- Effects of Varenicline, Depressive Symptoms, and Region of Enrollment on Smoking Cessation in Depressed Smokers.Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2019Trial
- Using REDCap for ambulatory assessment: Implementation in a clinical trial for smoking cessation to augment in-person data collection.The American journal of drug and alcohol abuse · 2019Trial
- Participant Adherence in Repeated-Dose Clinical Studies Using Video-Based Observation: Retrospective Data Analysis.JMIR mHealth and uHealth · 2025Article
- Emerging Medications for Treatment-Resistant Depression: A Review with Perspective on Mechanisms and Challenges.Brain sciences · 2025Review
- Pairwise comparisons of three medication adherence outcomes in adolescents who use alcohol.Alcohol, clinical & experimental research · 2023Article
- Medication Adherence in Tobacco Cessation Clinical Trials.Addiction neuroscience · 2023Article
- (Non-) impact of task experience on behavioral economic decision-making.Experimental and clinical psychopharmacology · 2022Article
- DOT Diary: Developing a Novel Mobile App Using Artificial Intelligence and an Electronic Sexual Diary to Measure and Support PrEP Adherence Among Young Men Who Have Sex with Men.AIDS and behavior · 2021Article
- Frequency of concealment, fabrication and falsification of study data by deceptive subjects.Contemporary clinical trials communications · 2021Article
- Digitally Enabled, Patient-Centric Clinical Trials: Shifting the Drug Development Paradigm.Clinical and translational science · 2021Review
- Learning from lorcaserin: lessons from the negative clinical trial of lorcaserin to treat cocaine use disorder.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2020Review
- Article
- How the EMERGE guideline on medication adherence can improve the quality of clinical trials.British journal of clinical pharmacology · 2020Review
- Recent Stressful Life Events in Euthymic Major Depressive Disorder Patients: Sociodemographic and Clinical Characteristics.Frontiers in psychiatry · 2020Article
- Methods to reduce the incidence of false negative trial results in substance use treatment research.Current opinion in psychology · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
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 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.