Instruct: Identify the main and secondary category of Arxiv papers based on the titles and abstracts
Query: A pragmatic adaptive enrichment design for selecting the right target
  population for cancer immunotherapies   One of the challenges in the design of confirmatory trials is to deal with
uncertainties regarding the optimal target population for a novel drug.
Adaptive enrichment designs (AED) which allow for a data-driven selection of
one or more pre-specified biomarker subpopulations at an interim analysis have
been proposed in this setting but practical case studies of AEDs are still
relatively rare. We present the design of an AED with a binary endpoint in the
highly dynamic setting of cancer immunotherapy. The trial was initiated as a
conventional trial in early triple-negative breast cancer but amended to an AED
based on emerging data external to the trial suggesting that PD-L1 status could
be a predictive biomarker. Operating characteristics are discussed including
the concept of a minimal detectable difference, that is, the smallest observed
treatment effect that would lead to a statistically significant result in at
least one of the target populations at the interim or the final analysis,
respectively, in the setting of AED.

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The categories of this paper are: chem-ph
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The categories of this paper are: funct-an
9
The categories of this paper are: nlin
3
The categories of this paper are: physics
5
The categories of this paper are: gr-qc
12
The categories of this paper are: nucl-th
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The categories of this paper are: dg-ga
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The categories of this paper are: comp-gas
31
The categories of this paper are: ao-sci
7
The categories of this paper are: hep-th
25
The categories of this paper are: patt-sol
8
The categories of this paper are: hep-ex
11
The categories of this paper are: hep-lat
33
The categories of this paper are: plasm-ph
13
The categories of this paper are: quant-ph
37
The categories of this paper are: supr-con