Statistical reporting of clinical pharmacology research.
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.
University of the Free State, Bloemfontein, South Africa.|medac GmbH, Wedel, Germany.
Arne
0000-0002-4324-5820
A
Ring
University of the Free State, Bloemfontein, South Africa.|Quintiles Biostatistics, Bloemfontein, South Africa.
Robert
0000-0002-4145-3685
R
Schall
Norwich Medical School, University of East Anglia, UK.
Yoon K
0000-0001-9109-2307
YK
Loke
Clinical Trials Consulting & Training Limited, Buckingham, UK.
Simon
S
Day
D003627:Data Interpretation, Statistical; D006801:Humans; D015233:Models, Statistical; D010601:Pharmacology, Clinical / Q000706:statistics & numerical data*; D012106:Research; D018401:Sample Size
clinical pharmacology; confirmatory statistics; exploratory statistics; meta-analyses; randomized clinical trials