The Clinical Trials Business Office (CTBO) provides end-to-end professional services to investigators interested in conducting clinical research at Boston Children’s Hospital. Specifically, the CTBO oversees contract and budget development and negotiation for industry-sponsored clinical trials, investigator-initiated studies, and other sponsored clinical research, regardless of the source of funding. The CTBO manages the business requirements of engaging in clinical research at the Hospital, including making insurance coverage determinations, coordinating charges for routine- and research-related care, invoicing sponsors, and ensuring compliance with state and federal billing regulations. In coordination with the Clinical Research Center, the Center for Clinical Investigation (IRB), Research Affairs and other BCH research departments and programs, the CTBO also offers education and training on a variety of topics aimed at helping research faculty and staff properly conduct and manage clinical trials.
Boston Children's Hospital houses over 200 specialty clinics, each of which could be a potential clinical trial site. Boston Children’s Hospital has long been a major site for clinical trials in a number of areas, including muscular dystrophy, through our Neuromuscular Program, Cystic Fibrosis, through our CF Center, and metabolic disorders. More recently, we have launched clinics in Fragile X, Tuberous Sclerosis and Rett Syndrome, rapidly bringing together the patient population and clinical trial infrastructure needed when a laboratory discovery leads to the suggestion of a trial in clinic that could help our patients. Since many of our clinicians are also researchers, many of our INDs are physician-sponsored. As a leading academic research hospital, Boston Children's is also a pioneer in developing cutting-edge treatment modalities for the rarest of disorders. For example, in 2010, Children’s took the lead in launching the first gene therapy trial in the United States in over a decade to treat children with X-linked severe combined immunodeficiency (SCID-X1).