The Use of Central Laboratories and Remote Electronic Data Capture to Risk-Adjust Therapy for Pediatric Acute Lymphoblastic Leukemia and Neuroblastoma

Abstract

The Children's Oncology Group (COG) is a National Cancer Institute (NIH)-sponsored cooperative clinical trials group with the primary mission of conducting pediatric cancer clinical trials. COG has complex risk classification systems that are used to deliver risk-stratified therapy for many pediatric cancers, including clinical trials for acute lymphoblastic leukemia (ALL) and neuroblastoma (NB). Classification of patients is based on biological, clinical, and genomic data obtained at initial diagnosis and during the initial phases of therapy. The COG Web-based remote data entry (RDE) system enables submission of data in real time from central laboratories and treating institutions. The data are then used in an automated fashion to determine the risk group and corresponding treatment assignment for individual patients enrolled in COG clinical trials.