Are randomized clinical trials necessary in cancer surgery?

Abstract

The article outlines the main principles of randomized clinical trials (RCTs) and discusses various problems related to their organization and performance. RCTs constitute a golden standard in medical literature, including surgical journals, but when badly constructed and conducted, they might cause more harm than good. The chief difficulties involved in organizing RCTs include the appropriate selection of patients, correct randomization, serious ethical concerns, and considerable cost. Their presence is attested to by the negligible number of RCTs, which only represent as few as 3 to 7% of all surgical studies. Cancer surgery is often radical and irreversible and requires respect for the preferences of patients and surgeons. It is not a lab experiment where everything can be neatly planned and carried out. In RCTs, study groups differ in terms of one variable. Cancer surgery, on the other hand, needs to take into account many different variables describing the patient, the disease, and the surgeon at the same time. The results of randomized studies cannot be applied across the board, even for patients who suffer from the same cancer. The findings are true only for the group of patients who participate in the study and their generalization to the whole patient population raises a serious objection.

There is a great need for clinical studies in cancer surgery, no matter whether they are randomized or not. Large, prospective, multi-center cohort studies, well-kept cancer registries, retrospective studies, and clinical case series furnish a very useful and precious source of knowledge. Expert consensus conferences are particularly valuable in practical terms. In recent years, there has been increasing pressure on reference centers from the medical industry and business to perform randomized trials. Studies of this kind, especially when published in high-impact journals, play an important role in introducing new equipment, methods, and drugs to clinical practice.

This causes a reasonable objection. Something must be “afoot” if all studies are currently required to feature a conflict-of-interests (COI) formula. To sum up, cancer surgery needs scientific studies, but not necessarily only RCTs. The author is against the overemphasis on randomized trials and the impact factor in clinical practice.