BOIN 设计参数 p.tox 的选择是否应仅取决于目标 DLT 率？
Should the choice of BOIN design parameter p.tox only depend on the target DLT rate?
AI总结：
该研究探讨BOIN设计中p.tox参数选择不应仅依赖目标DLT率，提出在特定条件下调整参数或队列规模以优化操作特征，并分析3+3设计变体的边界表生成条件。
摘要：
当早期停止参数 n.earlystop 相对较小，或队列规模（cohortsize）未经模拟优化时，使用 p.tox < 1.4 * target.DLT.rate 可能更好，或者尝试不同的队列规模，或增加 n.earlystop，选择既可行又能提供更优操作特征（operating characteristics）的方案。这是因为如果队列规模未经模拟优化，即使 n.earlystop = 12，使用 p.tox = 1.4 * target.DLT.rate 生成的 BOIN 升/降剂量规则，可能与使用 p.tox > 3 * target.DLT.rate 计算的规则完全相同，这对于某些以 10% DLT 率为目标的儿科试验可能不可接受。传统的 3+3 设计在以下情况停止剂量寻找过程：当前剂量水平已有 3 名患者接受治疗，观察到 0 例 DLT，且下一个更高剂量已被排除。如果在上述情况下要求在当前剂量额外治疗 3 名患者，则相应的边界表可使用目标 DLT 率在 18% 至 29% 之间、p.saf 在 8% 至 26% 之间、p.tox 在 39% 至 99% 之间的 BOIN 设计生成。为生成此 3+3 设计变体的边界表，BOIN 参数还需满足一组条件。
英文摘要：
When the early stopping parameter n.earlystop is relatively small or the cohortsize value is not optimized via simulation, it may be better to use p.tox < 1.4 * target.DLT.rate, or try out different cohort sizes, or increase n.earlystop, whichever is both feasible and provides better operating characteristics. This is because if the cohortsize was not optimized via simulation, even when n.earlystop = 12, the BOIN escalation/de-escalation rules generated using p.tox = 1.4 * target.DLT.rate could be exactly the same as those calculated using p.tox > 3 * target.DLT.rate, which might not be acceptable for some pediatric trials targeting 10% DLT rate. The traditional 3+3 design stops the dose finding process when 3 patients have been treated at the current dose level, 0 DLT has been observed, and the next higher dose has already been eliminated. If additional 3 patients were required to be treated at the current dose in the situation described above, the corresponding boundary table could be generated using BOIN design with target DLT rates ranging from 18% to 29%, p.saf ranging from 8% to 26%, and p.tox ranging from 39% to 99%. To generate the boundary table of this 3+3 design variant, BOIN parameters also need to satisfy a set of conditions.
机构、总结、中文摘要均由AI分析而来，可能存在错误，请以论文正文为准。
