Clinical Trials in Surgical Oncology

As physicians and research scientists, we can affect change and improve cancer outcomes in many ways. Historically, physicians work at the ground level managing individual patients. At this level, we diagnose their illness, help them make decisions, treat their cancers, and follow them long term. This interaction is noble and defines our profession. In addition to this, as researchers, we can also affect change at a population level. Research scientists can define new mechanisms and targets in the laboratory that can lead to drug development and new treatment options for patients. And, as clinical researchers, we can evaluate new drugs, biomarkers, and treatment sequencing in the context of clinical trials that can change existing paradigms and improve outcomes. The importance of clinical trials was recently highlighted by the Southwest Oncology Group (SWOG), which conducted a study evaluating all phase 3 trials from the adult National Clinical Trials Network (NCTN) groups (SWOG, Alliance, NRG, and ECOG-ACRIN) reported from 1980 onward, with statistically significant findings. In total, 163 trials that enrolled 108,102 patients were evaluated. These trials were estimated to have generated gains of 14 million life-years to patients with cancer. This analysis highlights the importance of clinical trials, the role of drug discovery, and the critical role of government-sponsored cancer research in extending and improving the lives of patients with cancer.

In this issue of Surgical Oncology Clinics of North America, we have asked some of the leading clinical researchers in the field of Surgical Oncology to discuss the importance and impact of conducting clinical trials. This issue can be used as a primer for trainees, as well as established surgeons, on how to develop clinical studies both at an institutional level and within the framework of the NCTN cooperative group structure. We have also summarized “The State of Science” with an update on the most surgically relevant clinical trials broken down by disease-based articles. Last, we also focus an article on the need to improve diversity and equity in conducting clinical trials. If results from these studies are to be applicable to broad populations, the trial participants need to reflect, as much as possible, the population of patients with the disease. We know that differences in response to therapy can exist among different ethnic and racial populations based on nuclear polymorphisms, pharmacogenomics, and other factors. Thus, an emphasis on improving diversity and equity within clinical trial enrollment, as well as interpretation of results, will be necessary for future studies. In closing, we would like to dedicate this issue of Surgical Oncology Clinics of North America to all the patients with cancer and their families that have enrolled and participated in clinical trials with the goal of improving cancer care for future patients.