Clinical Trials in Surgery: The Role of the American College of Surgeons Oncology Group

Excerpt

Over the past several decades, prospective randomized clinical trials have emerged at the pinnacle of evidence-based medical practice. They have been pivotal in defining optimal therapies and in evaluating novel agents, particularly for patients afflicted by cancer. Multi-institutional trial participation has not only enabled recruitment of adequate subjects within a feasible time frame but also has propagated promising new treatments to many patients. The modern era of clinical trials research was heralded by a trial conducted in 1948 by the Medical Research Council of Great Britain. This trial, featuring prospective randomization, placebo control, and blinded assessments, evaluated the efficacy of streptomycin in the treatment of pulmonary tuberculosis.1,2 In 1955, under the governance of the National Cancer Institute (NCI), a formal clinical trials cooperative group program was established in the United States. (Table 1). The ten cooperative groups, currently monitored by the Clinical Trials Evaluation Program (CTEP) of the NCI, mainly support therapeutic trials aimed at improving patient survival and quality of life. Additional goals of the cooperative group program include accumulation of clinical data and biological specimens for use in adjunctive studies addressing molecular mechanisms of disease, epidemiology/cancer control, and clinical trials methodology research.3 From 1955 until the mid-1970s, several nationwide cooperative groups were established in the United States, emphasizing the multimodal therapy for treatment of cancers. Additional groups were formed based on shared interests in specific diseases (e.g., Gynecologic Oncology Group [GOG]), in specific treatment modalities (e.g., Radiation Therapy Oncology Group [RTOG]), or on specific expertise (e.g., Children’s Oncology Group [COG]). Finally, in 1996, after a hiatus of more than 17 years, the most recent cooperative group, the American College of Surgeons Oncology Group (ACOSOG) was founded as an organization whose mission was to evaluate the surgical management of patients with malignant solid tumors through the performance of prospective clinical trials. …