Development, review, and conduct of Children's Oncology Group (COG) Clinical Trials

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Abstract Childhood cancer is the leading cause of disease-related death in children in the United States. The Children’s Oncology Group (COG), one of five clinical trials groups supported by the National Clinical Trials Network (NCTN), brings together more than 10,000 experts in childhood cancer representing diverse disciplines. More than 90% of the approximately 16,000 children and adolescents diagnosed with cancer each year in the United States are cared for at COG member institutions. The COG has nearly 100 clinical trials open, including trials to refine front-line therapy for childhood cancer, study novel approaches to patients with recurrent disease, advance understanding of cancer biology, and improve supportive care and quality of life for cancer survivors. The functioning of COG is dependent upon scientific oversight for protocol development that occurs centrally and oversight of clinical trial conduct that occurs locally at more than 200 member sites. Dr. Jeffrey Dome has been a steady and substantial contributor to the COG ever since its inception over 20 years ago at both the central and local levels. At the groupwide level, his major contribution has been his leadership of the Renal Tumor Committee. From 2006-2016, he served as chair of this committee, which entailed oversight of more than 6,000 patients enrolled on the Biology and Classification Study and four front-line therapeutic trials. He successfully guided the committee through the completion of the first generation of COG studies for childhood kidney cancers, resulting in clinical practice change across the country. He remains involved as an advisor to the current committee chair, member of the AREN1721, AREN1921, and AREN2231 study committees, associate vice-chair for publications and leader of the efforts to foster collaborations with international cooperative groups. Dr. Dome also serves on the COG Executive Committee, which advises the Group Chair on science and operations, and the COG Scientific Council, which reviews all the new concepts and major amendments before they are reviewed by the NCI steering committees. Future directions include opening three new COG renal tumor studies for favorable histology Wilms tumor, malignant rhabdoid tumor and bilateral Wilms tumor as well as furthering the study of novel biomarkers such as circulating tumor DNA. At the local level, Dr. Dome serves as the institutional Principal Investigator for COG studies at Children’s National Hospital, one of the largest and most active COG sites. Between 2018-2020, Children’s National had 379 COG clinical trial enrollments, including 115 phase 1 enrollments and 37 phase 2 enrollments. In 2020, Children’s National was in the 98th percentile of all COG sites for therapeutic enrollments. Future directions include improving the quality assurance and regulatory oversight infrastructure to accommodate the increasing complexity of COG trials. The NCI Research Specialist Award will provide an excellent mechanism to protect Dr. Dome’s time to continue to advance COG science.