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Conducting Clinical Trials II: Operational Execution

  • J. Rick Turner
Chapter

Abstract

The logistics of operationally executing a clinical trial are enormous. Consider a therapeutic confirmatory trial involving 5,000 subjects participating at a total of 100 investigational sites that are spread across several continents. Identifying potential subjects and then recruiting and retaining the required number is one challenge. Shipping the drug products for the clinical trial (the investigational and control drugs) to investigational sites located in various countries spread around the globe is another. Making sure that all necessary data are measured and recorded is a major task, as is managing and storing the data. And the list goes on. Of necessity, this chapter is far from exhaustive in its descriptions of operational aspects of running a clinical trial. Rather, its aim is to give you a feel of some of the challenges encountered and the ways that organizations which conduct trials function at an operational level.

Keywords

Physician Office Drug Development Process Subject Recruitment Operational Execution Physician Site 
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.

Further Readings

  1. McFadden E, 2007, Management of Data in Clinical Trials. Hoboken, NJ: Wiley.CrossRefGoogle Scholar
  2. Robinson M, Cook S, 2006, Clinical Trials Risk Management. Boca Raton, FL: CRC/Taylor & Francis.Google Scholar
  3. Spilker B, 2009, Guide to Drug Development: A Comprehensive Review and Assessment. Philadelphia: Wolters Kluwer/Lippincott Williams & Wilkins [Note: This is a comprehensive book (1277 pages) on the process of drug development. I would like to acknowledge that I have drawn from several of its chapters in the preparation of this chapter.]Google Scholar
  4. Woodin E, Schneider JC, 2003, The CRA’s Guide to Monitoring Clinical Research. Boston, MA: CenterWatch/Thomas Healthcare.Google Scholar
  5. www.ctmginc.com/; “CTMG—the world’s first Site Specific CRO”
  6. Gough J, Hamrell M, 2009, Standard Operating Procedures (SOPs): Why companies must have them, and why they need them. Drug Information Journal, 43:69–74.CrossRefGoogle Scholar
  7. Prokscha S, 2007, Practical Guide to Clinical Data Management, 2nd Edition. Boca Raton: Taylor & Francis.Google Scholar
  8. Gough J, Hamrell M, 2010, Standard Operating Procedures (SOPs): how companies can determine which documents they must put in place. Drug Information Journal, 44:49–54.CrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC 2010

Authors and Affiliations

  1. 1.Cardiac Safety Services QuintilesDurhamUSA

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