Instruct: Identify the main and secondary category of Arxiv papers based on the titles and abstracts
Query: The i3+3 Design for Phase I Clinical Trials   Purpose: The 3+3 design has been shown to be less likely to achieve the
objectives of phase I dose-finding trials when compared with more advanced
model-based designs. One major criticism of the 3+3 design is that it is based
on simple rules, does not depend on statistical models for inference, and leads
to unsafe and unreliable operating characteristics. On the other hand, being
rule-based allows 3+3 to be easily understood and implemented in practice,
making it the first choice among clinicians. Is it possible to have a
rule-based design with great performance? Methods: We propose a new rule-based
design called i3+3, where the letter "i" represents the word "interval". The
i3+3 design is based on simple but more advanced rules that account for the
variabilities in the observed data. We compare the operating characteristics
for the proposed i3+3 design with other popular phase I designs by simulation.
Results: The i3+3 design is far superior than the 3+3 design in trial safety
and the ability to identify the true MTD. Compared with model-based phase I
designs, i3+3 also demonstrates comparable performances. In other words, the
i3+3 design possesses both the simplicity and transparency of the rule-based
approaches, and the superior operating characteristics seen in model-based
approaches. An online R Shiny tool (https://i3design.shinyapps.io/i3plus3/) is
provided to illustrate the i3+3 design, although in practice it requires no
software to design or conduct a dose-finding trial. Conclusion: The i3+3 design
could be a practice-altering method for the clinical community.

22
The categories of this paper are: chao-dyn
1
The categories of this paper are: cs
17
The categories of this paper are: q-fin
2
The categories of this paper are: math
18
The categories of this paper are: econ
36
The categories of this paper are: cmp-lg
19
The categories of this paper are: eess
35
The categories of this paper are: mtrl-th
37
The categories of this paper are: supr-con
10
The categories of this paper are: q-bio
31
The categories of this paper are: ao-sci
0
The categories of this paper are: hep-ph
20
The categories of this paper are: acc-phys
15
The categories of this paper are: nucl-ex
9
The categories of this paper are: nlin
14
The categories of this paper are: math-ph