title: Biotechnology and clinical trials.
abstract: Not surprisingly, clinical trials have been critically important to developments in the field of biotechnology. Perhaps less expectedly, the clinical trials of biotechnology products have been critically important to recent developments in the field of clinical trials design, conduct, and analysis. This manuscript explores three examples of biotechnology clinical trials--a trial in sepsis, a trial in fibrinolytics in myocardial infarction, and trials in gene therapy--and highlights their contributions to the theory and practice of clinical research.
authors.affiliation: Office of Therapeutics Research and Review, Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, Maryland 20852, USA.
authors.forename: Jay P
authors.initials: JP
authors.lastname: Siegel
mesh_terms: D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized; D001709:Biotechnology; D002986:Clinical Trials as Topic / Q000592:standards*; D005343:Fibrinolytic Agents / Q000627:therapeutic use; D015316:Genetic Therapy; D006801:Humans; D009203:Myocardial Infarction / Q000188:drug therapy; D009954:Ornithine Carbamoyltransferase / Q000235:genetics / Q000627:therapeutic use; D020163:Ornithine Carbamoyltransferase Deficiency Disease / Q000628:therapy; D012107:Research Design; D018746:Systemic Inflammatory Response Syndrome / Q000188:drug therapy
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D005343:Fibrinolytic Agents; C068069:nebacumab; D009954:Ornithine Carbamoyltransferase