2 - History of Surgical Clinical Trials and Cooperative Group Trials

Abstract

Medicine and surgery have undergone drastic changes in the past century. This is due in part to the modernization of technology as well as new approaches and techniques for treatment. An ideal intervention or treatment will effectively treat the underlying condition while minimizing side effects and adverse events. Good clinical research rigorously tests hypotheses to determine if a new treatment method is effective or superior to existing therapy. Randomized controlled clinical trials specifically are designed to remove innate biases and examine causal relationships between intervention arms and outcomes. They are considered the “gold standard” of clinical trials as they minimize the risk of confounding factors. For these trials to show statistical differences, they need to be accurately powered and typically require a large, diverse sample size. The introduction of cooperative groups like the National Cancer Institute (NCI) clinical trials cooperative groups have had a significant impact on cancer prevention, treatment, and quality-of-life measures. These groups provide a network of researchers, clinicians, patient advocates, and others to design comprehensive clinical trials and then implement these trials in a varying, diverse population. A centralized group can streamline processes to make research more effective and efficient. These groups have been extremely influential in breast cancer treatment options. Surgical oncologists in both academic and community centers should grasp the opportunity to participate in this collaborative process, as there are several opportunities for them to do so. Patients can benefit from new treatments, and surgeons can improve their knowledge and abilities by participating in clinical trials. This chapter covers some of the most important trials that have advanced the progressive deescalation of treatments for breast cancer treatment.