Korn E L, Midthune D, Chen T T, Rubinstein L V, Christian M C, Simon R M
Biometric Research Branch, EPN-739, National Cancer Institute, Bethesda, MD 20892.
Stat Med. 1994 Sep 30;13(18):1799-806. doi: 10.1002/sim.4780131802.
Phase I cancer chemotherapy trials are designed to determine rapidly the maximum tolerated dose of a new agent for further study. A recently proposed Bayesian method, the continual reassessment method, has been suggested to offer an improvement over the standard design of such trials. We find the previous comparisons did not completely address the relative performance of the designs as they would be used in practice. Our results indicate that with the continual reassessment method, more patients will be treated at very high doses and the trials will take longer to complete. We offer some suggested improvements to both the standard design and the Bayesian method.
I期癌症化疗试验旨在快速确定一种新药物的最大耐受剂量，以便进一步研究。最近有人提出一种贝叶斯方法，即连续重新评估法，认为该方法比此类试验的标准设计有所改进。我们发现，之前的比较没有完全涉及这些设计在实际应用中的相对性能。我们的结果表明，采用连续重新评估法时，会有更多患者接受非常高剂量的治疗，试验完成所需时间也会更长。我们对标准设计和贝叶斯方法都提出了一些改进建议。
