In terms of explaining the probability of assignment to trial arms in consent forms, which is true?

Answer

ICH notes that it should be included, but does not specify how the information should be presented.

Explanation

In clinical trials, informed consent forms often include information about the probability of assignment to different treatment arms, such as experimental treatment or placebo. The International Council for Harmonisation (ICH) guidelines recommend that this information be included in the consent forms but do not provide specific details on how it should be presented. The FDA (Food and Drug Administration) does not mandate a specific statement about the probability either. The idea of "like the flip of a coin" is a commonly used example for clarity, but it is not a requirement from either regulatory body.