期刊
EUROPEAN NEUROPSYCHOPHARMACOLOGY
卷 22, 期 11, 页码 800-803出版社
ELSEVIER
DOI: 10.1016/j.euroneuro.2011.11.011
关键词
Placebo; Non-inferiority; Methodology; Psychopharmacology
资金
- Instituto de Salud Carlos III
- Centro de Investigacion Biomedica en Red de Salud Mental (CIBERSAM), Spain
- Almirall
- AstraZeneca
- Bristol-Myers Squibb
- Eli Lilly
- Forest Research Institute
- Gedeon Richter
- Glaxo-Smith-Kline
- Janssen-Cilag
- Jazz
- Johnson Et Johnson
- Lundbeck
- Merck
- Novartis
- Organon
- Otsuka
- Pfizer
- Pierre-Fabre
- Qualigen
- Sanofi-Aventis
- Servier
- Shering-Plough
- Solvay
- Takeda
- Spanish Ministry of Science and Innovation (CIBERSAM)
- Seventh European Framework Programme (ENBREC)
- Stanley Medical Research Institute
- United Biosource Corporation
- Wyeth
- American Psychiatric Association
- Astra Zeneca
- CIBERSAM
Head to head trials have been proposed as an alternative to the ethical and methodological concerns related to placebo-controlled trials. While those studies may be particularly informative from the clinical and cost-effectiveness point-of-view, avoiding placebo poses several regulatory concerns: for superiority designs, the choice of the trial population, outcomes, dose and escalation of the comparator, as well as the comparator itself may be an issue; for non-inferiority studies, issues related to uncertain assay sensitivity and exposure of large samples to potentially ineffective or unsafe drugs make them inappropriate, in the absence of a previous positive superiority trial, for regulatory purposes. The inclusion of active comparators in regulatory trials should not be seen as an alternative, but as a useful complement to the information that can be obtained from placebo-controlled studies. (C) 2011 Elsevier B.V. and ECNP. All rights reserved.
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