Why Do We Need Surgical Trials?

Randomized controlled trials are widely considered the most rigorous and ethical human subjects research designs available. However, in the case of surgical trials, they are particularly challenging to design, implement, execute, and complete. The fact that the subject cannot simply stop taking an experimental drug or decline further participation in a behavioral or non-interventional therapeutic study makes recruitment challenging. There are no “do-overs” in the decision to operate on a research subject. However, the very fact that surgical procedures cannot be undone is why there is a need for well-designed surgical trials. To ensure we are providing the best care possible for our patients. In this chapter, we review the reasons why we need surgical trials and what some of the key challenges are with the design, conduct, and completion of high-quality surgical trials.