Randomization in clinical trials minimizes the risk of bias, especially selection bias. The

different comparison groups allow the researchers to determine any effects of the treatment when

compared with the no treatment/no intervention (often usual care = control) group, while other

variables are kept constant. Hence, randomized clinical trials (RCTs) are considered the gold standard

for a clinical trial to test the efficacy of an intervention providing the highest level of evidence.

Consequently, evidence-based guidelines, systematic reviews including meta-analyses most often

even do not consider other types of studies. However, RCTs are seldom conducted in pharmacist-led

trials as they are in many aspects more challenging. This Masterclass of Excellence will provide an indepth

knowledge for current and future researchers in designing and performing pharmacistled/

pharmacy-based RCTs.