INCLUSION OF CHILDREN IN CLINICAL RESEARCH

Medical University Of South Carolina, Charleston SC

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Abstract

In accordance with NIH policy, the Hollings Cancer Center (HCC) strives to increase the participation of children in research so that adequate data can be developed to support the treatment modalities for pediatric oncology patients. The HCC is fully compliant with the NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Hu man Subjects. As part of the Medical University of South Carolina (MUSC) Institutional Review Board's application for approval to conduct research with human subjects, MUSC principal investigators are required to state specifically how children are included or provide a justification for their exclusion. South Carolina has a pediatric population of approximately 1.1 million individuals under the age of 18 years. State cancer registry data for 2009 (most recent data available) reported 199 new pediatric cancer cases in South Carolina. A multidisciplinary team of pediatric specialists representing MUSC's Division of Pediatric Hematology/Oncology in the Department of Pediatrics as well as the Departments of Surgery, Radiation Oncology, Neurosciences, Pathology, and Radiology manages the care of pediatric cancer patients. In 2012, the Division of Pediatric Hematology/Oncology welcomed two new faculty members. Ana Xavier, MD and Amy-Lee Bredlau, MD, enlarging the division to six full-time faculty. Dr. Bredlau joined MUSC as Director of the Pediatric Brain Tumor Program. Faculty members of the Pediatric Hematology/Oncology Division and the Division of Hematology/Oncology in the Department of Medicine interact frequently as they collaborate in decision-making and care plans for older teens and young adults. In general, the pediatric multidisciplinary team provides care for patients up to 18 years of age, although there are several exceptions each year depending on the needs of the patient. Pediatric cancer patients are seen in the outpatient setting of MUSC's Rutledge Tower and the pediatric oncology inpatient facilities of the MUSC Children's Hospital. As is typical of most pediatric oncology programs in the United States, the majority of newly diagnosed pediatric cancer patients at MUSC are evaluated for participation in a clinical research study. Pediatric oncology studies open at MUSC are largely from the NIH-funded Children's Oncology Group (COG). In addition to COG, MUSC is a member of the Pediatric Blood & Marrow Transplant Consortium, Blood & Marrow Transplant Clinical Trials Network, and the Neuroblastoma & Medulloblastoma Translational Research Consortium at the Van Andel Research Institute in Michigan. The MUSC pediatric oncology group screens every new patient for clinical trial participation. In 2012, there were 60 newly diagnosed pediatric cancer cases. Of these, 12 (20%) were enrolled into a treatment clinical trial. The remaining patients did not have an available trial to consider (52%), declined participation and elected to receive treatment closer to their home (20%), or did not meet eligibility criteria for an active enrolling trial (8%). For nontreatment studies, 40 (67%) patients were enrolled.