This article, written by Meg Egan Auderset at Clarivate Analytics,
describes how the new draft industry guidance from the US Food
and Drug Administration (FDA) underscores the importance of
randomised, double-blind, placebo-controlled trials to establish the
efficacy of drugs to treat male hypogonadotropic hypogonadism
when it is caused by obesity or another acquired condition. The draft
guidance also asserts the potential importance of patient-reported
outcome (PRO) instruments to such efficacy determinations, since
they offer “direct evidence of how patients feel or function.”