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U.C. Berkeley Division of Biostatistics Working Paper Series
Adaptive design; asymptotic normality; canonical distribution; clinical trial; group-sequential testing; targeted maximum likelihood methodology
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Estimation And Testing In Targeted Group Sequential Covariate-Adjusted Randomized Clinical Trials, Antoine Chambaz, Mark J. Van Der Laan
Estimation And Testing In Targeted Group Sequential Covariate-Adjusted Randomized Clinical Trials, Antoine Chambaz, Mark J. Van Der Laan
U.C. Berkeley Division of Biostatistics Working Paper Series
This article is devoted to the construction and asymptotic study of adaptive group sequential covariate-adjusted randomized clinical trials analyzed through the prism of the semiparametric methodology of targeted maximum likelihood estimation (TMLE). We show how to build, as the data accrue group-sequentially, a sampling design which targets a user-supplied optimal design. We also show how to carry out a sound TMLE statistical inference based on such an adaptive sampling scheme (therefore extending some results known in the i.i.d setting only so far), and how group-sequential testing applies on top of it. The procedure is robust (i.e., consistent even if the …