14.Randomization07.Non inferiority and equivalence - sporedata/researchdesigneR GitHub Wiki

1. Use cases: in which situations should I use this method?

The non-inferiority trial design is often used when the new intervention has an advantage over the standard of care other than effectiveness or efficacy. For example, it might less costly, easier to implement, among other factors. In this scenario, demonstrating that the new intervention has similar effectiveness or efficacy would make it preferable given these external characteristics.

2. Input: what kind of data does the method require?

3. Algorithm: how does the method work?

Model mechanics

The interpretation of non-inferiority results is depicted in the figure below, where the intervention is aimed at reducing the risk of an adverse event.

Reporting guidelines

  • CONSORT statement for non-inferiority trials [1].
  • Guidelines for the Content of Statistical Analysis Plans in Clinical Trials [2].

Data science packages

Suggested companion methods

Learning material

  1. Books *
  2. Articles
    • Treatment effects in multicenter randomized clinical trials [3].
    • Challenges in the Design and Interpretation of Noninferiority Trials [4].
    • Noninferiority trials: is a new treatment almost as effective as another? [5].
    • Common references for randomized designs

4. Output: how do I interpret this method's results?

Mock conclusions or most frequent format for conclusions reached at the end of a typical analysis.

Tables, plots, and their interpretation

5. SporeData-specific

Templates

Data science functions

References

[1] Piaggio G, Elbourne DR, Pocock SJ, Evans SJW, Altman DG, for the CONSORT Group. Reporting of noninferiority and equivalence randomized trials. Extension of the CONSORT 2010 statement. JAMA. 2012; 308(24): 2594-2604.

[2] Gamble C, Krishan A, Stocken D, Lewis S, Juszczak E, Doré C, Williamson PR, Altman DG, Montgomery A, Lim P, Berlin J. Guidelines for the Content of Statistical Analysis Plans in Clinical Trials. Jama. 2017 Dec 19;318(23):2337-43.

[3] Senn SJ, Lewis RJ. Treatment effects in multicenter randomized clinical trials. Jama. 2019 Mar 26;321(12):1211-2.

[4] Mauri L, D’Agostino Sr RB. Challenges in the Design and Interpretation of Noninferiority Trials. New England Journal of Medicine. 2017 Oct 5;377(14):1357-67.

[5] Kaji AH, Lewis RJ. Noninferiority trials: is a new treatment almost as effective as another?. JAMA. 2015 Jun 16;313(23):2371-2.

[6] Mascha EJ, Sessler DI. Equivalence and noninferiority testing in regression models and repeated-measures designs. Anesthesia & Analgesia. 2011 Mar 1;112(3):678-87.

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