ArticleCPT: pharmacometrics & systems pharmacology2018
A Systematic Evaluation of Effect of Adherence Patterns on the Sample Size and Power of a Clinical Study.
Article in CPT: pharmacometrics & systems pharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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Who cites it
13 citing papers in PubMed.
- An Interactive Pharmacokinetic-Pharmacodynamic Framework to Evaluate Bedaquiline Dose Modifications in Adults With Tuberculosis.CPT: pharmacometrics & systems pharmacology · 2026Article
- Preventing obesity-related cancer with the revolution in obesity management: the challenges of undertaking a clinical trial and potential solutions.British journal of cancer · 2026Review
- Safety and pharmacology of AMY109, a long-acting anti-interleukin-8 antibody, for endometriosis: a double-blind, randomized phase 1 trial.F&S reports · 2025Article
- Promising benefits of six-monthFrontiers in aging · 2025Article
- Mathematical models of Plasmodium vivax transmission: A scoping review.PLoS computational biology · 2024Article
- Pairwise comparisons of three medication adherence outcomes in adolescents who use alcohol.Alcohol, clinical & experimental research · 2023Article
- Medication adherence reporting in pivotal clinical trials: overview of oral oncological drugs.European journal of hospital pharmacy : science and practice · 2023Article
- Leveraging mathematical modeling to analyze nonadherence for hydroxyurea therapy in sickle cell disease.CPT: pharmacometrics & systems pharmacology · 2023Article
- A genome-wide association study of plasma concentrations of warfarin enantiomers and metabolites in sub-Saharan black-African patients.Frontiers in pharmacology · 2022Article
- Patient-Reported Outcomes as Endpoints in Clinical Trials of Kidney Transplantation Interventions.Transplant international : official journal of the European Society for Organ Transplantation · 2022Article
- Recruitment characteristics and non-adherence associated factors of fibromyalgia patients in a randomized clinical trial: A retrospective survival analysis.Contemporary clinical trials communications · 2021Article
- Digitally Enabled, Patient-Centric Clinical Trials: Shifting the Drug Development Paradigm.Clinical and translational science · 2021Review
- How the EMERGE guideline on medication adherence can improve the quality of clinical trials.British journal of clinical pharmacology · 2020Review
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The objective of our study was to evaluate the effect of adherence patterns on the sample size and power of a clinical trial. Simulations from a population pharmacokinetic/pharmacodynamic (PK/PD) model linked to an adherence model were used. Four types of drug characteristics, such as long (~35 hours) and short (~12 hours) half-life in combination with earlier or delayed time to reach steady-state PD end points were studied. Adherence patterns were simulated using Markov chains. Our results clearly demonstrate the significant impact of varying levels and patterns of nonadherence on the sample size and power of a study. For drugs with short half-lives the evidence to support efficacy could be diluted by various patterns of nonadherence that would make its efficacy indistinguishable from the response to placebo. Prospectively utilizing clinical trial simulations with thorough incorporation of various adherence patterns would provide valuable information when designing a trial.
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