Biotechnology and clinical trials

J Infect Dis. 2002 Feb 15;185 Suppl 1:S52-7. doi: 10.1086/338061.


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.

Publication types

  • Review

MeSH terms

  • Antibodies, Monoclonal / therapeutic use
  • Antibodies, Monoclonal, Humanized
  • Biotechnology*
  • Clinical Trials as Topic / standards*
  • Fibrinolytic Agents / therapeutic use
  • Genetic Therapy
  • Humans
  • Myocardial Infarction / drug therapy
  • Ornithine Carbamoyltransferase / genetics
  • Ornithine Carbamoyltransferase / therapeutic use
  • Ornithine Carbamoyltransferase Deficiency Disease / therapy
  • Research Design*
  • Systemic Inflammatory Response Syndrome / drug therapy


  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Fibrinolytic Agents
  • nebacumab
  • Ornithine Carbamoyltransferase