Skip to main content
SpringerLink
Log in

ASO Author Reflections: Current Issues in Conduct and Reporting of Noninferiority Randomized Controlled Trials in the Surgical Management of Cancer Patients

  • ASO Author Reflections
  • Published:
Annals of Surgical Oncology Aims and scope Submit manuscript

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

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

References

  1. Piaggio G, Elbourne DR, Pocock SJ, Evans SJ, Altman DG, Group C. Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. JAMA. 2012;308(24):2594–604.

    Article  Google Scholar 

  2. Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ, Group C. Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. JAMA. 2006;295(10):1152–60.

    Article  Google Scholar 

  3. FDA. Non-inferiority clinical trials to establish effectiveness guidance for industry. Food and Drug Administration US Department of Health and Human Services. 2016.

  4. Aberegg SK, Hersh AM, Samore MH. Empirical consequences of current recommendations for the design and interpretation of noninferiority trials. J Gen Intern Med. 2018;33(1):88–96.

    Article  Google Scholar 

  5. Rehal S, Morris TP, Fielding K, Carpenter JR, Phillips PP. Non-inferiority trials: are they inferior? A systematic review of reporting in major medical journals. BMJ Open. 2016;6(10):e012594.

    Article  Google Scholar 

  6. Turgeon RD, Reid EK, Rainkie DC. Design and interpretation of noninferiority trials. J Gen Intern Med. 2018;33(8):1215.

    Article  Google Scholar 

  7. Aberegg S. Reporting noninferiority trials. JAMA. 2013;309(15):1584–5.

    Article  CAS  Google Scholar 

  8. Paesmans M, Grigoriu B, Ocak S, et al. Systematic qualitative review of randomised trials conducted in nonsmall cell lung cancer with a noninferiority or equivalence design. Eur Respir J. 2015;45(2):511–24.

    Article  CAS  Google Scholar 

  9. Parsyan A, Marini W, Fazelzad R, Moher D, McCready D. Current issues in conduct and reporting of noninferiority randomized controlled trials in the surgical management of cancer patients. Ann Surg Oncol. 2020. https://doi.org/10.1245/s10434-020-08575-7.

  10. Macaya F, Ryan N, Salinas P, Pocock SJ. Challenges in the design and interpretation of noninferiority trials: insights from recent stent trials. J Am Coll Cardiol. 2017;70(7):894–903.

    Article  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Department of Surgery, University Health Network, Princess Margaret Hospital, University of Toronto, Toronto, ON, Canada

    Wanda Marini MD & David McCready MD

  2. Centre for Journalology, Ottawa Hospital Research Institute, Ottawa, ON, Canada

    David Moher PhD

  3. School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada

    David Moher PhD

  4. Departments of Surgery and Oncology, London Regional Cancer Program, St. Joseph’s Health Care and London Health Sciences Centre, Western University, London, ON, Canada

    Armen Parsyan MD, PhD, DSc, MPH

Authors
  1. Wanda Marini MD
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. David Moher PhD
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. David McCready MD
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Armen Parsyan MD, PhD, DSc, MPH
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Armen Parsyan MD, PhD, DSc, MPH.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Marini, W., Moher, D., McCready, D. et al. ASO Author Reflections: Current Issues in Conduct and Reporting of Noninferiority Randomized Controlled Trials in the Surgical Management of Cancer Patients. Ann Surg Oncol 27 (Suppl 3), 751–752 (2020). https://doi.org/10.1245/s10434-020-08589-1

Download citation

  • Received:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1245/s10434-020-08589-1

Search

Navigation