In contrast to randomised controlled trials (RCTs), single-arm clinical trials (SATs) are relatively simple by design: a sample of individuals receive an experimental treatment for a targeted condition, and are followed over a period of time to observe and evaluate their response to the treatment. RCTs are the gold standard when it comes to evaluating the efficacy of a new treatment, and are vital for marketing authorisation (MA) applications. However, in a distinct subset of MA applications, efficacy...
April 26, 2023
2 min read