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Randomised controlled trials (RCTs) support clinical practice by generating high quality evidence about the safety and effectiveness of medical interventions. However, RCTs are not required for the regulatory approval of new surgical procedures or devices. Surgical RCTs are subject to distinct practical challenges, and the quality of surgical trials has been criticised, although it appears to be improving. Few studies have directly compared the design features of surgical and non‐surgical trials, or examined differences between surgical clinical trials by specialty. We therefore determined the proportion of surgical clinical trials in Australia relative to all clinical trials and examined their characteristics, and compared surgical trial activity by specialty.

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Authors: Claire Greenwell, Angela Webster, Ian A Harris, David Beard, Angie Barba and Sarah J Lord

Article Type: Research Letter