Dr Randall on Challenges Associated With Incorporating Surgical Protocols Into Sarcoma Clinical Trials

“In general, all surgical trials are more difficult to run than nonsurgical trials. [In nonsurgical trials], there are stringent and appropriate ethics around [the use of an investigational] medication [vs] placebo or a backbone therapy, [and] you still have some sense of a standard of care [in the control arm]. With surgical trials, where you are being, by definition, invasive, [patients undergo] a variety of circumstances that can dramatically change the course of [their] lives.”

R. Lor Randall, MD, FACS, the David Linn Endowed Chair for Orthopaedic Surgery and chair of the Department of Orthopaedic Surgery at the University of California, Davis Health, discussed the distinct challenges associated with incorporating surgical protocols into clinical trials for patients with sarcoma.

According to Randall, surgical trials present inherent complexities not typically encountered in medical oncology studies. Unlike trials investigating systemic therapies, where patients may receive a placebo, standard-of-care treatment, or a combination with an investigational agent, surgical interventions are inherently invasive and irreversible, he said. This invasiveness introduces ethical considerations and makes the informed-consent process more difficult, he reported. Patients must weigh the risks of an experimental surgical approach that could permanently alter function, quality of life, or long-term outcomes, he stated.

Randall also emphasized that the practice culture among surgeons presents an additional barrier to conducting surgical trials. He noted that surgical techniques are frequently shaped by individual training, institutional experience, and personal preference. Surgeons may hold strong convictions about operative approaches, creating resistance to standardized trial protocols, he continued. Randall acknowledged this cultural aspect, describing the surgical community as confident and often reluctant to deviate from established practices. However, this presents challenges for collaboration across institutions and the consistent application of trial procedures, he contextualized.

Despite these challenges, Randall highlighted the necessity of integrating surgical trials into sarcoma research. Addressing both the ethical and logistical obstacles will be critical for advancing the field, he concluded.