One-sided or two-sided p values: which most appropriately address the question of drug efficacy?
- PMID: 1844684
- DOI: 10.1080/10543409108835010
One-sided or two-sided p values: which most appropriately address the question of drug efficacy?
Abstract
Whether a one-sided or a two-sided p value should be used for reporting the results of an analysis should be determined by the a priori question the investigation seeks to answer. It is concluded that one-sided p values are appropriate in clinical trials whose objective is to provide definitive, confirmatory evidence of efficacy of pharmaceutical compounds.
Comment in
-
Directional decision for a two-tailed alternative.J Biopharm Stat. 1996 May;6(2):211-8. doi: 10.1080/10543409608835134. J Biopharm Stat. 1996. PMID: 8732915 No abstract available.
Similar articles
-
Some thoughts on the one-sided and two-sided tests.J Biopharm Stat. 1991;1(1):139-50. doi: 10.1080/10543409108835011. J Biopharm Stat. 1991. PMID: 1844685 Review.
-
One-sided and two-sided tests and p values.J Biopharm Stat. 1991;1(1):161-70. doi: 10.1080/10543409108835014. J Biopharm Stat. 1991. PMID: 1844688 Review.
-
Situations where formal confirmatory analysis is inappropriate for clinical research.J Biopharm Stat. 1991;1(1):121-32. doi: 10.1080/10543409108835009. J Biopharm Stat. 1991. PMID: 1844683 Review.
-
The use of one-sided tests in drug trials: an FDA advisory committee member's perspective.J Biopharm Stat. 1991;1(1):151-6. doi: 10.1080/10543409108835012. J Biopharm Stat. 1991. PMID: 1844686 Review.
-
Implementing type I & type II error spending for two-sided group sequential designs.Contemp Clin Trials. 2008 May;29(3):351-8. doi: 10.1016/j.cct.2007.09.002. Epub 2007 Sep 21. Contemp Clin Trials. 2008. PMID: 17933592
Cited by
-
Simulation-based training for increasing health service board members' effectiveness: a cluster randomised controlled trial.BMJ Open. 2020 Dec 13;10(12):e034994. doi: 10.1136/bmjopen-2019-034994. BMJ Open. 2020. PMID: 33318104 Free PMC article. Clinical Trial.
-
Chronic nicotinamide riboside supplementation is well-tolerated and elevates NAD+ in healthy middle-aged and older adults.Nat Commun. 2018 Mar 29;9(1):1286. doi: 10.1038/s41467-018-03421-7. Nat Commun. 2018. PMID: 29599478 Free PMC article. Clinical Trial.
-
An exploratory randomised double-blind and placebo-controlled phase 2 study of a combination of baclofen, naltrexone and sorbitol (PXT3003) in patients with Charcot-Marie-Tooth disease type 1A.Orphanet J Rare Dis. 2014 Dec 18;9:199. doi: 10.1186/s13023-014-0199-0. Orphanet J Rare Dis. 2014. PMID: 25519680 Free PMC article. Clinical Trial.
-
Confirmatory Efficacy of Cognitive Enhancement Therapy for Early Schizophrenia: Results From a Multisite Randomized Trial.Psychiatr Serv. 2022 May;73(5):501-509. doi: 10.1176/appi.ps.202000552. Epub 2021 Sep 2. Psychiatr Serv. 2022. PMID: 34470506 Free PMC article. Clinical Trial.
Publication types
MeSH terms
LinkOut - more resources
Full Text Sources
Medical