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Full-Text Articles in Statistics and Probability
Adaptive, Group Sequential Designs That Balance The Benefits And Risks Of Wider Inclusion Criteria, Michael Rosenblum, Brandon S. Luber, Richard E. Thompson, Daniel F. Hanley
Adaptive, Group Sequential Designs That Balance The Benefits And Risks Of Wider Inclusion Criteria, Michael Rosenblum, Brandon S. Luber, Richard E. Thompson, Daniel F. Hanley
Johns Hopkins University, Dept. of Biostatistics Working Papers
We propose a new class of adaptive randomized trial designs aimed at gaining the advantages of wider generalizability and faster recruitment, while mitigating the risks of including a population for which there is greater a priori uncertainty. Our designs use adaptive enrichment, i.e., they have preplanned decision rules for modifying enrollment criteria based on data accrued at interim analyses. For example, enrollment can be restricted if the participants from predefined subpopulations are not benefiting from the new treatment. To the best of our knowledge, our designs are the first adaptive enrichment designs to have all of the following features: the …
Adaptive Randomized Trial Designs That Cannot Be Dominated By Any Standard Design At The Same Total Sample Size, Michael Rosenblum
Adaptive Randomized Trial Designs That Cannot Be Dominated By Any Standard Design At The Same Total Sample Size, Michael Rosenblum
Johns Hopkins University, Dept. of Biostatistics Working Papers
Prior work has shown that certain types of adaptive designs can always be dominated by a suitably chosen, standard, group sequential design. This applies to adaptive designs with rules for modifying the total sample size. A natural question is whether analogous results hold for other types of adaptive designs. We focus on adaptive enrichment designs, which involve preplanned rules for modifying enrollment criteria based on accrued data in a randomized trial. Such designs often involve multiple hypotheses, e.g., one for the total population and one for a predefined subpopulation, such as those with high disease severity at baseline. We fix …