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Success in Academic Surgery: Clinical Trials pp 1–10Cite as

Building Your Clinical Trial Research Team

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Part of the book series: Success in Academic Surgery ((SIAS))

Abstract

Clinical trials have become increasingly complex and depend upon the collaboration of multiple highly skilled personnel with quite different skill sets. Two of the most important elements in the conduct of successful clinical trials are (1) assembling a good clinical trial research team and (2) defining the role and contributions of each. This chapter will review the members of a clinical trial research team, detail their roles, and discuss how to assemble the various personnel for a successful, sustainable clinical trial.

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References

  1. Barnes M, Korn J. Medicare reimbursement for clinical trial services: understanding Medicare coverage in establishing a clinical trial budget. J Health Law. 2005;38(4):609–31.

    PubMed  Google Scholar 

  2. Bodenheimer T. Uneasy alliance-clinical investigators and the pharmaceutical industry. N Engl J Med. 2000;342:1539.

    Article  PubMed  CAS  Google Scholar 

  3. Carbone PP, Tormey DC. Organizing multicenter trials: lessons from the cooperative oncology groups. Prev Med. 1991;20(1):162–9.

    Article  PubMed  CAS  Google Scholar 

  4. Cohen JM. Training institutional review board members. In: Institutional review and board management and function. 2nd ed. Amdur RJ, Bankert EA, editors. Sudbury: Jones and Bartlett; 2002. p. 313.

    Google Scholar 

  5. Finn PB. The negotiation and development of a clinical trial agreement. J Biolaw Bus. 2006;9(2):21–7.

    PubMed  Google Scholar 

  6. Friedman L, DeMets D. The data monitoring committee: how it operates and why. IRB. 1981;3(4):6–8.

    Article  PubMed  Google Scholar 

  7. Kassirer JP, Angell M. On authorship and acknowledgments. N Engl J Med. 1991;325:1510–2.

    Article  PubMed  CAS  Google Scholar 

  8. Leong SP, editor. Cancer clinical trials: proactive strategies. New York: Springer; 2007.

    Google Scholar 

  9. Lind J. A treatise on the scurvy. London: A. Millar; 1753.

    Google Scholar 

  10. National Cancer Institute at the National Institute of Health [Internet]. Bethesda. Available from http://www.cancer.gov.

  11. O’Neill RT. FDAs critical path initiative: a perspective on contribution of biostatistics. Biom J. 2006;48(4):559–64.

    Article  PubMed  Google Scholar 

  12. Ott MB, Yingling GL. Guide to good clinical practice. Tab. 1999;100:7.

    Google Scholar 

  13. Rusch VW. Surgeons: a future role in clinical trials? Oncologist. 1997;2(3):5–6.

    Google Scholar 

  14. Shafer H. Adaptive designs from the viewpoint of an academic biostatistician. Biom J. 2006;48(4):586–90; discussion 613–22.

    Article  Google Scholar 

  15. Shea S, Bigger JT, Campion J, et al. Enrollment in clinical trials: institutional factors affecting enrollment in the Cardiac Arrhythmia Suppression Trial (CAST). Control Clin Trials. 1992;13:466–86.

    Article  PubMed  CAS  Google Scholar 

  16. Tognoni G, Alli C, Avanzini F, et al. Randomized clinical trials in general practice: lessons learned from a failure. BMJ. 1991;303:969–71.

    Article  PubMed  CAS  Google Scholar 

  17. US Food and Drug Administration [Internet]. Silver Spring MD. Available from http://www.fda.gov. Updated 29 Mar 2013.

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Author information

Authors and Affiliations

  1. Department of General Surgery, UCSF Mt Zion Medical Center, 1600 Divisadero Street, 1674, San Francisco, CA, 94143, USA

    Jessica E. Gosnell MD

  2. University of California, San Francisco, CA, USA

    Jessica E. Gosnell MD

Authors
  1. Jessica E. Gosnell MD
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Corresponding author

Correspondence to Jessica E. Gosnell MD .

Editor information

Editors and Affiliations

  1. Department of Surgery, Johns Hopkins, Baltimore, USA

    Timothy M. Pawlik

  2. Department of Surgery,, Duke University School of Medicine,, Durham, North Carolina, USA

    Julie A. Sosa

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© 2014 Springer-Verlag London

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Gosnell, J.E. (2014). Building Your Clinical Trial Research Team. In: Pawlik, T., Sosa, J. (eds) Success in Academic Surgery: Clinical Trials. Success in Academic Surgery. Springer, London. https://doi.org/10.1007/978-1-4471-4679-7_1

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  • DOI: https://doi.org/10.1007/978-1-4471-4679-7_1

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  • Publisher Name: Springer, London

  • Print ISBN: 978-1-4471-4678-0

  • Online ISBN: 978-1-4471-4679-7

  • eBook Packages: MedicineMedicine (R0)

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