A concise display of multiple end points for benefit-risk assessment
- PMID: 21107317
- DOI: 10.1038/clpt.2010.251
A concise display of multiple end points for benefit-risk assessment
Erratum in
- Clin Pharmacol Ther. 2011 Mar;89(3):468
Abstract
The assessment and representation of benefit-risk "balance" in pharmaceutical development have become increasingly important. Although the methodologies may vary considerably in complexity, most approaches to benefit-risk assessment require the simultaneous consideration of information pertaining to multiple end points for multiple treatments. However, the lengthy data tables and displays that are frequently used make this assessment difficult. Using an example from the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia study, this note presents a conceptually simple visualization that facilitates understanding of information on multiple points.
Similar articles
-
Discontinuing and switching antipsychotic medications: understanding the CATIE schizophrenia trial.J Clin Psychiatry. 2007;68 Suppl 1:12-9. J Clin Psychiatry. 2007. PMID: 17286523
-
What do large scale studies of medication in schizophrenia add to our management strategies?Psychiatr Danub. 2010 Jun;22(2):323-8. Psychiatr Danub. 2010. PMID: 20562774 Review.
-
Benefit and risk assessment in drug development and utilization: a role for clinical pharmacology.Clin Pharmacol Ther. 2007 Aug;82(2):109-12. doi: 10.1038/sj.clpt.6100277. Clin Pharmacol Ther. 2007. PMID: 17632530 No abstract available.
-
Graphical approaches to the analysis of safety data from clinical trials.Pharm Stat. 2008 Jan-Mar;7(1):20-35. doi: 10.1002/pst.254. Pharm Stat. 2008. PMID: 17323410
-
Antipsychotic safety and efficacy concerns.J Clin Psychiatry. 2007;68 Suppl 14:20-6. J Clin Psychiatry. 2007. PMID: 18284274 Review.
Cited by
-
TFOS DEWS II Clinical Trial Design Report.Ocul Surf. 2017 Jul;15(3):629-649. doi: 10.1016/j.jtos.2017.05.009. Epub 2017 Jul 20. Ocul Surf. 2017. PMID: 28736344 Free PMC article. Review.
-
A proposal for using benefit-risk methods to improve the prominence of adverse event results when reporting trials.Trials. 2024 Jun 22;25(1):409. doi: 10.1186/s13063-024-08228-0. Trials. 2024. PMID: 38909232 Free PMC article.
-
Benefit-risk assessment of paliperidone oral extended-release tablet versus monthly injectable for maintenance treatment of schizophrenia.Int Clin Psychopharmacol. 2016 Nov;31(6):315-22. doi: 10.1097/YIC.0000000000000141. Int Clin Psychopharmacol. 2016. PMID: 27434314 Free PMC article. Clinical Trial.
-
Within-drug benefit-risk evaluation of olanzapine long-acting injection at one and two years of treatment.Int J Methods Psychiatr Res. 2014 Dec;23(4):439-50. doi: 10.1002/mpr.1443. Epub 2014 Jul 3. Int J Methods Psychiatr Res. 2014. PMID: 24996038 Free PMC article.
-
Benefit-Risk Assessment of Esketamine Nasal Spray vs. Placebo in Treatment-Resistant Depression.Clin Pharmacol Ther. 2021 Feb;109(2):536-546. doi: 10.1002/cpt.2024. Epub 2020 Oct 13. Clin Pharmacol Ther. 2021. PMID: 32860422 Free PMC article. Clinical Trial.
Publication types
MeSH terms
Substances
LinkOut - more resources
Full Text Sources