title: Clinical Trials and the Role of the Oncology Clinical Trials Nurse.
abstract: Clinical trials are paramount to improving human health. New trial designs and informed consent issues are emerging as a result of genomic profiling and the development of molecularly targeted agents. Many groups and individuals are responsible for ensuring the protection of research participants and the quality of the data produced. The specialty role of the clinical trials nurse (CTN) is critical to clinical trials. Oncology CTNs have competencies that can help guide their practice; however, not all oncology clinical trials are supervised by a nurse. Using the process of engagement, one organization has restructured oncology CTNs under a nurse-supervised model.
authors.affiliation: Office of Education and Compliance, Center for Cancer Research, National Cancer Institute, 10 Center Drive, Room 3-2571, MSC 1206, Bethesda, MD 20892, USA. Electronic address: nesse@mail.nih.gov.
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Ness
authors.affiliation: Office of Research Nursing, Center for Cancer Research, National Cancer Institute, 10 Center Drive, Room 3-2571, MSC 1206, Bethesda, MD 20892, USA.
authors.forename: Cheryl
authors.initials: C
authors.lastname: Royce
mesh_terms: D035843:Biomedical Research / Q000458:organization & administration*; D002983:Clinical Competence; D002986:Clinical Trials as Topic; D006801:Humans; D024802:Nurse's Role; D009859:Oncology Nursing / Q000458:organization & administration*; D012107:Research Design
keywords: Clinical trials; Clinical trials nurse; Oncology trial design; Research nurse competencies; Research nursing office