  Purpose: During discussions at the Data Science Roundtable meeting in Japan,
there were instances where the adoption of the BOIN design was declined,
attributed to the extension of study duration and increased sample size in
comparison to the 3+3 design. We introduce an accelerated BOIN design aimed at
completing a clinical phase I trial at a pace comparable to the 3+3 design.
Additionally, we introduce how we could have applied the BOIN design within our
company, which predominantly utilized the 3+3 design for most of its clinical
oncology dose escalation trials. Methods: The accelerated BOIN design is
adaptable by using efficiently designated stopping criterion for the existing
BOIN framework. Our approach is to terminate the dose escalation study if the
number of evaluable patients treated at the current dose reaches 6 and the
decision is to stay at the current dose for the next cohort of patients. In
addition, for lower dosage levels, considering a cohort size smaller than 3 may
be feasible when there are no safety concerns from non-clinical studies. We
demonstrate the accelerated BOIN design using a case study and subsequently
evaluate the performance of our proposed design through a simulation study.
Results: In the simulation study, the average difference in the percentage of
correct MTD selection between the accelerated BOIN design and the standard BOIN
design was -2.43%, the average study duration and the average sample size of
the accelerated BOIN design was reduced by 14.8 months and 9.22 months,
respectively, compared with the standard BOIN design. Conclusion: We conclude
that our proposed accelerated BOIN design not only provides superior operating
characteristics but also enables the study to be completed as fast as the 3+3
design.
