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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.

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: 2020/02/16 18:48 by ranstam