Model-Informed Approach to Assess the Treatment Effect Conditional to the Level of Placebo Response.
Journal
Clinical pharmacology and therapeutics
ISSN: 1532-6535
Titre abrégé: Clin Pharmacol Ther
Pays: United States
ID NLM: 0372741
Informations de publication
Date de publication:
12 2019
12 2019
Historique:
received:
16
04
2019
accepted:
22
06
2019
pubmed:
10
8
2019
medline:
5
6
2020
entrez:
10
8
2019
Statut:
ppublish
Résumé
One of the most important reasons for failure of placebo-controlled randomized controlled clinical trials (RCTs) is the lack of appropriate methodologies for detecting treatment effect (TE; difference between placebo and active treatment response) in the presence of excessively low/high levels of placebo response. Although, the higher the level of placebo response in a trial, the lower the apparent detectable TE. TE is usually estimated in a conventional analysis of an RCT as an "apparent" TE value conditional to the level of placebo response in that RCT. A model-informed methodology is proposed to establish a relationship between level of placebo response and TE. This relationship is used to estimate the "typical" TE associated with a "typical" level of placebo response, irrespective of the level of placebo response observed. The approach can be valuable for providing a reliable estimate of TE, for conducting risk/benefit analysis, and for determining dosage recommendations.
Substances chimiques
Antidepressive Agents
0
Paroxetine
41VRH5220H
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1253-1260Informations de copyright
© 2019 The Authors Clinical Pharmacology & Therapeutics © 2019 American Society for Clinical Pharmacology and Therapeutics.
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