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ICH E9: Statistical principles for clinical trials [31] section III provides a general overview of common designs in clinical trials. ICH E10: Choice of control group in clinical trials [ 32 ] describes the general principles involved in choosing a control group for clinical trials intended to demonstrate the efficacy of a treatment and to ...
[11] Expert statistical and medical judgment must select the method most appropriate to the particularly trial conditions of the available imperfect techniques, depending on the particular trial's goals, endpoints, statistical methods, and context.
Randomized clinical trials analyzed by the intention-to-treat (ITT) approach provide unbiased comparisons among the treatment groups. Intention to treat analyses are done to avoid the effects of crossover and dropout, which may break the random assignment to the treatment groups in a study.
Matching is a statistical technique that evaluates the effect of a treatment by comparing the treated and the non-treated units in an observational study or quasi-experiment (i.e. when the treatment is not randomly assigned).
The rule is useful in the interpretation of clinical trials generally, particularly in phase II and phase III where often there are limitations in duration or statistical power. The rule of three applies well beyond medical research, to any trial done n times. If 300 parachutes are randomly tested and all open successfully, then it is concluded ...
Minimisation is a method of adaptive stratified sampling that is used in clinical trials, as described by Pocock and Simon. [1] [2]The aim of minimisation is to minimise the imbalance between the number of patients in each treatment group over a number of factors.