User Tools

Site Tools


Clinical trials

Egbewale BE, Lewis M, Sim J. Bias, precision and statistical power of analysis of covariance in the analysis of randomized trials with baseline imbalance: a simulation study. BMC Medical Research Methodology 2014;14:49.

Evans S. When and How Can Endpoints Be Changed after Initiation of a Randomized Clinical Trial? PLoS Clin Trials. 2007 Apr; 2(4): e18.

EMA. ICH E9 Statistical principles for clinical trials. European Medicines Agency, London, September 1998, CPMP/ICH/363/96.

EMA. Points to consider in missing data. European Medicines Agency, London, November 15 2001, CPMP/EWP/1776/99.

EMA. Points to consider on multiplicity issues in clinical trials. European Medicines Agency, London, 19 September 2002, CPMP/EWP/908/99.

EMA. Points to consider on adjustment for baseline covariates. European Medicines Agency, London, 22 May 2003, CPMP/EWP/2863/99.

EMA. Points to consider on switching between superiority and non-inferiority. European Medicines Agency, London, 27 July 2000, CPMP/EWP/482/99.

EMA. Guideline on the choice of non-inferiority margin. European Medicines Agency. London, 27 July 2005. EMEA/CPMP/EWP/2158/99.

Kahan BC, Morris TP. Improper analysis of trials randomised using stratified blocks or minimisation. Stat Med 2012;31:328-340.

Lachin JM. Statistical Considerations in the Intent-to-Treat Principle. Contr Clin Trials 2000;21:167-189.

Leyrat C, Morgan KE, Leurent B, Kahan BC. Cluster randomized trials with a small number of clusters: which analyses should be used? Int J Epidemiol 2018;47:321-331.

Li G, Taljaard M, Van den Heuvel ER, Levine MAH, Cook DJ, Wells GA, Devereaux PJ, Thabane L, An introduction to multiplicity issues in clinical trials: the what, why, when and how, International Journal of Epidemiology, Volume 46, Issue 2, April 2017, Pages 746–755,

Moher AD, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials. Br Med J 2010;340:c869.

Schulz KF, Grimes DA. Generation of allocation sequences in randomised trials: chance, not choice. Lancet 2002;359:515–519.

Schulz KF, Grimes DA. Allocation concealment in randomised trials: defending against deciphering. Lancet 2002;359:614–618.

clinical_trials.txt · Last modified: 2020/04/07 09:23 by ranstam