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Model‐Informed Approach to Assess the Treatment Effect Conditional to the Level of Placebo Response.
- Source :
- Clinical Pharmacology & Therapeutics; Dec2019, Vol. 106 Issue 6, p1253-1260, 8p
- Publication Year :
- 2019
-
Abstract
- 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. [ABSTRACT FROM AUTHOR]
- Subjects :
- TREATMENT effectiveness
CLINICAL trials
PLACEBOS
Subjects
Details
- Language :
- English
- ISSN :
- 00099236
- Volume :
- 106
- Issue :
- 6
- Database :
- Complementary Index
- Journal :
- Clinical Pharmacology & Therapeutics
- Publication Type :
- Academic Journal
- Accession number :
- 139620775
- Full Text :
- https://doi.org/10.1002/cpt.1584