Advertisement

Clinical Trials

  • Edward D. Zanders
Chapter

Abstract

This chapter outlines the different phases of clinical trials, starting with phase I human volunteer studies through to phase III studies using large numbers of patients. The overview includes case histories of a phase I and a phase III trial to illustrate their design and implementation. Also covered are the regulatory applications for the first time in human studies.

Keywords

Bone Mineral Density Accelerator Mass Spectrometry Accelerator Mass Spectrometry Preclinical Development Clinical Trial Report 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

References

  1. Baylis F (2010) Pregnant women deserve better. Nature 465:689–690PubMedCrossRefGoogle Scholar
  2. Bekker PJ et al (2004) A single-dose placebo-controlled study of AMG 162, a fully human monoclonal antibody to RANKL, in postmenopausal women. J Bone Mineral Res 19:1059–1066CrossRefGoogle Scholar
  3. Cummings SR et al (2009) Denosumab for prevention of fractures in postmenopausal women with osteoporosis. N Engl J Med 361:756–765PubMedCrossRefGoogle Scholar
  4. Dilts DM et al (2008) Development of clinical trials in a cooperative group setting: The Eastern Cooperative Oncology Group. Clin Cancer Res 14:3427–3433PubMedCrossRefGoogle Scholar
  5. Duff G (2006) Expert scientific group on phase one clinical trials. The Stationery Office, LondonGoogle Scholar
  6. EUMAPP (2011). http://www.eumapp.com/. Accessed 17 Jan 2011
  7. FDA clinical trials links (2010). http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm. Accessed 25 Nov 2010
  8. ICH Guidelines Efficacy topics (2011). http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html. Accessed 17 Jan 2011
  9. WHO International Clinical Trials Registry Platform (2010). http://www.who.int/ictrp/en/. Accessed 25 Nov 2010
  10. Jenkins JM et al (2007) Phase 1 clinical study of eltrombopag, an oral nonpeptide thrombopoietin receptor agonist. Blood 109:4739–4741PubMedCrossRefGoogle Scholar
  11. Lewiecki EM et al (2007) Two-year treatment with denosumab (AMG 162) in a randomized phase 2 study of postmenopausal women with low BMD. J Bone Miner Res 22:1832–1841PubMedCrossRefGoogle Scholar
  12. McDonald AM et al (2006) What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials 7:9, doi: 10.1186/1745-6215-7-9 PubMedCrossRefGoogle Scholar
  13. Menon U et al (2008) Recruitment to multicentre trials-lessons from UKCTOCS: descriptive study. BMJ. doi: doi: 10.1136/bmj.a2079 Google Scholar
  14. NIH’s Clinicaltrials.gov (2010). Accessed 25 Nov 2010Google Scholar

Copyright information

© Springer Science+Business Media, LLC 2011

Authors and Affiliations

  1. 1.PharmaGuide LtdHertsUK

Personalised recommendations