Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Editorial
. 2017 Jun;83(6):1159-1162.
doi: 10.1111/bcp.13254. Epub 2017 Mar 21.

Statistical reporting of clinical pharmacology research

Arne Ring  1   2 , Robert Schall  1   3 , Yoon K Loke  4 , Simon Day  5
Affiliations
Editorial

Statistical reporting of clinical pharmacology research

Arne Ring et al. Br J Clin Pharmacol. 2017 Jun.

Abstract

Research in clinical pharmacology covers a wide range of experiments, trials and investigations: clinical trials, systematic reviews and meta-analyses of drug usage after market approval, the investigation of pharmacokinetic-pharmacodynamic relationships, the search for mechanisms of action or for potential signals for efficacy and safety using biomarkers. Often these investigations are exploratory in nature, which has implications for the way the data should be analysed and presented. Here we summarize some of the statistical issues that are of particular importance in clinical pharmacology research.

Keywords: clinical pharmacology; confirmatory statistics; exploratory statistics; meta-analyses; randomized clinical trials.

PubMed Disclaimer

References

    1. Sheiner LB. Learning versus confirming in clinical drug development. Clin Pharmacol Ther 1997; 61: 275–291. - PubMed
    1. Wasserstein RL, Lazar NA. The ASA's statement on p‐values: context, process, and purpose. Am Statistician 2016; 70: 129–133.
    1. CHMP 2010 – Guideline on the investigation of bioequivalence. CPMP/EWP/QWP/1401/98 Rev. 1/Corr
    1. Julious SA, Debarnot CA. Why are pharmacokinetic data summarized by arithmetic means? J Biopharm Stat 2000; 10: 55–71. - PubMed
    1. Smith B. Statistical guide for clinical pharmacology & therapeutics. Clin Pharmacol Ther 2010; 88: 150–152. - PubMed

Publication types

LinkOut - more resources