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Editorial
Discusses the challenges and potential solutions for conducting randomized clinical trials in surgery, including exception from informed consent, central IRBs, and Bayesian approaches.
Designing and completing randomized clinical trials (RCTs) in surgery is especially challenging due to unique barriers in study design, patient recruitment, and the administrative logistics of multicenter collaborative studies.1-5 Surgical interventions are typically more complex to study than pharmacologic interventions, particularly when comparing surgery with a placebo arm and attempting to blind parties to the intervention.3,5-7 Selecting and assessing patient-centered outcomes for surgical trials also pose challenges, and the risks of bias are high.
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Maiga et al. (2024) studied this question.
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