The science and conduct of surgical trials in gynecologic oncology: A practical framework

Surgical trials have been among the most important drivers of practice change in gynecologic oncology, generating evidence across ovarian, endometrial, cervical, and vulvar cancer. These studies have demonstrated that the surgical approach, extent of resection, treatment sequence, and integration with systemic therapies profoundly affect survival, perioperative morbidity, and long-term quality of life, yet the credibility, interpretability, and clinical impact of surgical trials depend not only on their design but also on the way they are conducted. Unlike pharmacologic trials, surgical trials are uniquely vulnerable to bias arising from variability in surgeon expertise, intraoperative decision-making, institutional infrastructure, and adherence to protocol-defined techniques. Failure to adequately standardize or consistently implement treatment protocols may obscure the true effects of an intervention, compromise the internal validity of the study, and diminish the external validity and generalizability of the findings. Conversely, rigorous and well-executed trials enable researchers to make definitive, practice-changing conclusions. This review provides a comprehensive framework for the conduct of multicenter, surgical trials, focusing on key domains including eligibility determination, the timing and implementation of randomization, surgical credentialing, the standardization of surgical procedures, quality assurance, outcome selection, the integration of patient-reported outcomes, patient accrual and informed consent, and equitable trial participation. By outlining principles that balance methodological rigor with pragmatic relevance, this review highlights how optimized trial conduct is essential to generating reliable evidence, accelerating surgical innovation, and improving oncologic and patient-centered outcomes for women with gynecologic cancers.