How the EMERGE guideline on medication adherence can improve the quality of clinical trials.
adherence
clinical trials
pharmacokinetic-pharmacodynamic
Journal
British journal of clinical pharmacology
ISSN: 1365-2125
Titre abrégé: Br J Clin Pharmacol
Pays: England
ID NLM: 7503323
Informations de publication
Date de publication:
04 2020
04 2020
Historique:
received:
05
12
2018
revised:
27
11
2019
accepted:
12
01
2020
pubmed:
9
2
2020
medline:
29
7
2021
entrez:
9
2
2020
Statut:
ppublish
Résumé
Medication adherence in drug trials is suboptimal, affecting the quality of these studies and adding significant costs. Nonadherence in this setting can lead to null findings, unduly large sample sizes and the need for dose modification after a drug has been approved. Despite these drawbacks, adherence behaviours are not consistently measured, analysed or reported appropriately in trial settings. The ESPACOMP Medication Adherence Reporting Guideline (EMERGE) offers a solution by facilitating a sound protocol design that takes this crucial factor into account. This article summarises key evidence on traditional and newer measurements of adherence, discusses implementation in clinical trial settings and makes recommendations about the analysis and interpretation of adherence data. Given the potential benefits of this approach, the authors call on regulators and the pharmaceutical industry to endorse the EMERGE guideline.
Identifiants
pubmed: 32034923
doi: 10.1111/bcp.14240
pmc: PMC7098872
doi:
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
687-697Informations de copyright
© 2020 The British Pharmacological Society.
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