Skip to main content

Statistics: Setting the Stage

  • Chapter
  • First Online:
  • 1950 Accesses

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

Abstract

This chapter introduces fundamental statistical concepts in the design of clinical trials that must be considered early on in the planning phases of a project.

This is a preview of subscription content, log in via an institution.

Buying options

Chapter
USD   29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD   54.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD   69.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Learn about institutional subscriptions

References

  1. Winter K, Pugh SL, editors. An investigator’s introduction to statistical considerations in clinical trials. Urologic oncology: seminars and original investigations. Amsterdam: Elsevier; 2019.

    Google Scholar 

  2. Akobeng AK. Understanding randomised controlled trials. Arch Dis Childhood. 2005;90(8):840–4.

    Article  CAS  Google Scholar 

  3. Rohrig B, du Prel JB, Blettner M. Study design in medical research: part 2 of a series on the evaluation of scientific publications. Dtsch Arztebl Int. 2009;106(11):184–9.

    PubMed  PubMed Central  Google Scholar 

  4. Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2012;10(1):28–55.

    Article  Google Scholar 

  5. Van Belle G, Fisher LB. Biostatistics: a methodology for the health sciences. 2nd ed. Hoboken: Wiley; 2004. p. 15–9.

    Book  Google Scholar 

  6. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332.

    Article  Google Scholar 

  7. Pawlik TM, Sosa JA. Success in academic surgery: clinical trials. 1st Edition. Springer. 2014. Pg 14, section 2.3; ISBN 978-1-4471-4679-7

    Google Scholar 

  8. Schulz KF, Grimes DA. Generation of allocation sequences in randomised trials: chance, not choice. Lancet. 2002;359(9305):515–9.

    Article  Google Scholar 

  9. Peckham E, Brabyn S, Cook L, Devlin T, Dumville J, Torgerson DJ. The use of unequal randomisation in clinical trials—an update. Contemp Clin Trials. 2015;45:113–22.

    Article  Google Scholar 

  10. Torgerson DJ, Campbell MK. Use of unequal randomisation to aid the economic efficiency of clinical trials. BMJ. 2000;321(7263):759.

    Article  CAS  Google Scholar 

  11. Suresh K. An overview of randomization techniques: an unbiased assessment of outcome in clinical research. J Hum Reprod Sci. 2011;4(1):8.

    Article  Google Scholar 

  12. Scott NW, McPherson GC, Ramsay CR, Campbell MK. The method of minimization for allocation to clinical trials: a review. Control Clin Trial. 2002;23(6):662–74.

    Article  Google Scholar 

  13. Schulz KF, Grimes DA. Allocation concealment in randomised trials: defending against deciphering. Lancet. 2002;359(9306):614–8.

    Article  Google Scholar 

  14. Spieth PM, Kubasch AS, Penzlin AI, Illigens BM-W, Barlinn K, Siepmann T. Randomized controlled trials—a matter of design. Neuropsy Dis Treat. 2016;12:1341.

    Google Scholar 

  15. Kendall JM. Designing a research project: randomised controlled trials and their principles. Emerg Med J. 2003;20(2):164–8.

    Article  CAS  Google Scholar 

  16. Farrokhyar F, Karanicolas PJ, Thoma A, Simunovic M, Bhandari M, Devereaux P, et al. Randomized controlled trials of surgical interventions. Annal Surg. 2010;251(3):409–16.

    Article  Google Scholar 

  17. Axelrod DA, Hayward R. Nonrandomized interventional study designs (quasi-experimental designs). Clinical research methods for surgeons. New York: Springer; 2006. p. 63–76.

    Google Scholar 

  18. Thoma A, Farrokhyar F, Bhandari M, Tandan V. Users’ guide to the surgical literature. How to assess a randomized controlled trial in surgery. Can J Surg. 2004;47(3):200–8.

    PubMed  PubMed Central  Google Scholar 

  19. Ford I, Norrie J. Pragmatic trials. N Engl J Med. 2016;375(5):454–63.

    Article  Google Scholar 

  20. Chang TI, Winkelmayer WC. Comparative effectiveness research: what is it and why do we need it in nephrology? Nephrol Dia Transplant. 2012;27(6):2156–61.

    Article  Google Scholar 

  21. Lesaffre E. Superiority, equivalence, and non-inferiority trials. Bull NYU Hosp Jt Dis. 2008;66(2)

    Google Scholar 

  22. Schulz KF, Grimes DA. Sample size calculations in randomised trials: mandatory and mystical. Lancet. 2005;365(9467):1348–53.

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Adil H. Haider .

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 2020 Springer Nature Switzerland AG

About this chapter

Check for updates. Verify currency and authenticity via CrossMark

Cite this chapter

Arain, M.A., Haider, A.H., Hashmi, Z.G. (2020). Statistics: Setting the Stage. In: Pawlik, T., Sosa, J. (eds) Clinical Trials. Success in Academic Surgery. Springer, Cham. https://doi.org/10.1007/978-3-030-35488-6_9

Download citation

  • DOI: https://doi.org/10.1007/978-3-030-35488-6_9

  • Published:

  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-030-35487-9

  • Online ISBN: 978-3-030-35488-6

  • eBook Packages: MedicineMedicine (R0)

Publish with us

Policies and ethics