Web-based open source application for the randomization process in clinical trials: RANDI2.

摘要

The randomization process is pivotal for clinical trials with more than one treatment arm. This is because the same boundary conditions have to be used whenever new therapies are being compared with standard treatments or other experimental treatments. Kendall [3] describes "Chance" as a random error appearing to cause an association between an intervention and an outcome. The most important design strategy to minimize such random error is to have a large sample size. Randomization is based on four mathematical concepts: (i) complete randomization with probability p = 1 for the choice of one treatment out of n with identically distributed Bernoulli random variables, (ii) restricted randomization with a variance-covariance matrix unequal 1/4 I (unique matrix), (iii) covariate adapted, and (iv) response adapted randomization.