Clinical Trials in Surgical Oncology

This issue of the Surgical Oncology Clinics of North America focuses on clinical trials in oncology. Clinical trials are critical to develop and test new treatment modalities for a broad range of disease states. In fact, over the past two years we have witnessed and benefited from clinical trials related to COVID-19 that have made headlines, saved millions of lives, as well as given us the chance to return to some degree of normalcy. In the field of cancer, each of us has also witnessed the important “game-changing” and potentially lifesaving opportunities afforded to our patients through clinical trials. Clinical trials are the backbone of evidence-based treatment guidelines, translate research into clinical practice, and improve the quality of care. Data from clinical trials provide the “evidence” in “evidence-based medicine.” In fact, it’s estimated that almost one-half of phase 3 trials influence guideline care or new drug approvals. In turn, appropriately planned and well-executed clinical trials provide a unique opportunity to address gaps that still exist in patient care. Unfortunately, clinical trial participation among adults in the United States remains low at less than 5% and is even lower among racial/ethnic minority groups, as well as certain disenfranchised patient populations. The low rate of clinical trial participation has been attributed to limited knowledge about clinical trials, poor geographical access to trial locations, as well as skepticism and cynicism relative to trial participation among traditionally disadvantaged patient populations. The surgeon plays a central role in the conception, design, implementation, and accrual to clinical trials. In addition, surgeons need to be equipped to analyze and interpret clinical trial data in order to disseminate and apply new emerging therapeutic information to the care of their patients. Given the importance and central role of clinical trials to oncologic care, I am grateful to have Syed A. Ahmad, MD and Shishir K. Maithel, MD as the guest editors of this important issue of Surgical Oncology Clinics of North America. Dr Ahmad is the Hayden Family Endowed Chair for Research and Professor of Surgery at the University of Cincinnati College of Medicine. Dr Ahmad serves as the Division Chief of Surgical Oncology as well as the Director of the University of Cincinnati Cancer Center. Dr Ahmad is the primary investigator of several national clinical trials as well as serves as the Surgical Chair for the Southwest Oncology Group. Dr Maithel is Professor of Surgery at Emory University where he is Scientific Director of the Liver and Pancreas Center. As chair of the Gastrointestinal Surgery Working Group of the Eastern Cooperative Oncology Group and the American College of Radiology Imaging Network Cancer Research Group, Dr Maithel evaluates the production of forward-looking clinical trials that focus on biomarker-driven cancer investigations. Both coeditors have extensive experience and leadership in the area of clinical trials and have published extensively in the field of oncology. As such, Dr Ahmad and Dr Maithel are imminently qualified to be the guest editors of this important issue of Surgical Oncology Clinics of North America.

The issue covers a range of important topics related to clinical trials. In particular, this issue highlights the fundamentals of conducting cooperative trials and how to leverage national trial networks as well as touches on investigator-initiated trials. In addition to these cross-cutting topics, the authors also provide a contemporary state-of-the-art update on clinical trials across a wide range of oncologic diseases. In particular, the team of expert coauthors provides data from clinical trials related to tumors, including breast cancer, melanoma, esophageal and gastric cancer, as well as hepatopancreaticobiliary malignancies, colorectal cancer, sarcoma, and neuroendocrine tumors. In addition, the important topic of diversity, equity, and inclusion in clinical trials is highlighted.

I wish to express my sincere gratitude to Dr Ahmad and Dr Maithel for their efforts to identify such a wonderful group of leaders in the field of clinical trials. These expert authors have done an incredible job emphasizing the various aspects of clinical trials as well as describing cancer-specific clinical trial data that will prove helpful to both trainees and faculty. I know that this issue of Surgical Oncology Clinics of North America will serve cancer providers well in acquainting them with the latest up-to-date data on clinical trials in oncology. I would like to thank Dr Ahmad and Dr Maithel and all the expert authors again for an outstanding issue of the Surgical Oncology Clinics of North America.