Sample size considerations to assess sex-related treatment effects.

Randomized controlled trials (RCTs) represent the gold standard for establishing the efficacy of new interventions. Yet, RCTs are often conducted in selected populations, not representative of those at risk for or living with the disease. This lack of representativeness has raised concerns about the generalizability of RCT results to those populations not (adequately) represented in RCTs, in particular in the absence of evidence on potential …