A commentary on: statistical inference problems in sequential parallel comparison designs

Journal of Biopharmaceutical Statistics
D A SchoenfeldMaurizio Fava

Abstract

A Sequential Parallel Comparison Design has two stages, the first comparing drug to placebo and the second comparing drug to placebo among patients who did not respond to placebo in the first stage. The paper, Statistical Inference Problems in Sequential Parallel Comparison Designs, claims that the estimate of the treatment difference in the second stage is biased and that under certain circumstances, a suggested hypothesis test will reject the null hypothesis when it should be accepted. This rejoinder argues that the estimate in the second stage is not biased when the true target of estimation (estimand) is properly understood. Further, the null hypothesis that the authors posit is not the correct null hypothesis for clinical trials, and in the situation, they describe that the treatment should be considered to be effective.

References

Sep 13, 2007·Clinical Trials : Journal of the Society for Clinical Trials·Roy N Tamura, Xiaohong Huang
Feb 2, 2008·Cleveland Clinic Journal of Medicine·Bradley N GaynesMaurizio Fava
Aug 2, 2011·Statistics in Medicine·Anastasia IvanovaDavid A Schoenfeld
Apr 14, 2015·Statistics in Medicine·Denis RybinMaurizio Fava
Feb 7, 2016·Progress in Neuro-psychopharmacology & Biological Psychiatry·Mu-Hong Chen, Shih-Jen Tsai
Sep 16, 2016·Nature Reviews. Disease Primers·Christian OtteAlan F Schatzberg
May 30, 2017·Neuropsychopharmacology : Official Publication of the American College of Neuropsychopharmacology·Sanjay J MathewGerard Sanacora
Jul 1, 2015·Therapeutic Innovation & Regulatory Science·Ann-Kristin LeuchsNorbert Benda

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Citations

Aug 29, 2019·Biometrical Journal. Biometrische Zeitschrift·Gosuke Homma, Takashi Daimon

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