Mitigating the Effects of Nonadherence in Clinical Trials
| Autor: | Earle Bain, Thomas M. Shiovitz, Thomas P. Laughren, Daniel Burch, Phil Skolnick, Adam Hanina, David J. McCann |
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| Rok vydání: | 2015 |
| Předmět: |
Male
medicine.medical_specialty Internationality Alternative medicine MEDLINE Medication adherence computer.software_genre Medication Adherence 03 medical and health sciences 0302 clinical medicine Protocol design Statistical analyses medicine Humans Pharmacology (medical) Clinical Trials 030212 general & internal medicine professional subjects adherence Intensive care medicine Pharmacology Clinical Trials as Topic nonadherence business.industry Clinical trial duplicate subjects Patient Compliance Female Data mining Patient Participation business computer 030217 neurology & neurosurgery |
| Zdroj: | Journal of Clinical Pharmacology |
| ISSN: | 1552-4604 |
| Popis: | Accounting for subject nonadherence and eliminating inappropriate subjects in clinical trials are critical elements of a successful study. Nonadherence can increase variance, lower study power, and reduce the magnitude of treatment effects. Inappropriate subjects (including those who do not have the illness under study, fail to report exclusionary conditions, falsely report medication adherence, or participate in concurrent trials) confound safety and efficacy signals. This paper, a product of the International Society for CNS Clinical Trial Methodology (ISCTM) Working Group on Nonadherence in Clinical Trials, explores and models nonadherence in clinical trials and puts forth specific recommendations to identify and mitigate its negative effects. These include statistical analyses of nonadherence data, novel protocol design, and the use of biomarkers, subject registries, and/or medication adherence technologies. |
| Databáze: | OpenAIRE |
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