Maluish A E
Lymphokine Res. 1986;5 Suppl 1:S183-7.
Phase I clinical trials of Biological Response Modifiers must be designed to provide information not only regarding toxicities, pharmacokinetics and anti-tumor response, but also on their many immunomodulatory properties. If BRMs are to be used rationally, then detailed standardized data must be obtained in such a way as to enable meaningful conclusions to be drawn from the monitoring assays. Assay selection, timing for monitoring and methods for data interpretation are important considerations in the design of such trials.
生物反应调节剂的I期临床试验设计不仅要提供有关毒性、药代动力学和抗肿瘤反应的信息，还要提供有关其多种免疫调节特性的信息。如果要合理使用生物反应调节剂，那么必须以能够从监测分析中得出有意义结论的方式获取详细的标准化数据。分析方法的选择、监测时间和数据解释方法是此类试验设计中的重要考虑因素。
