CLINICAL TRIALS OF BIOLOGICAL RESPONSE MODIFIERS

承包商将进行生物反应的临床试验 癌症患者中的修饰剂。 与项目干事合作， 承包商将根据 合同年。待研究的药剂将由政府或 经项目主管批准。 所有临床方案将 提交给项目官员以供NCI批准。 的总目标 该合同将解决使用中的基本问题， 用于治疗患者的单克隆抗体和靶向剂 得了癌症 每项临床试验的开发、实施和分析都将作为 一个具体的任务。 至少，每个方案将评估 治疗方案的毒副反应，探讨抗肿瘤作用的机制 和耐药性，观察临床抗肿瘤反应，并监测特异性 适用于临床试验并由 项目官员。 在每项临床试验结束时， 承包商将在书面临床试验报告中总结结果 提交给项目负责人。

The Contractor will conduct clinical trials of biological response modifiers in cancer patients. Working with the Project Officer, the Contractor will identify two or more clinical trials to be conducted per contract year. Agents to be studied will be supplied by the government or otherwise approved by the Project Officer. All clinical protocols will be submitted to the Project Officer for NCI approval. The overall goal of the contract will be to address fundamental issues in the use of monoclonal antibodies and targeting agents in the treatment of patients with cancer. Each clinical trial will be developed, conducted, and analyzed as part of a specific Task Order. At a minimum, each protocol will assess the toxicity of the treatment regimen, explore mechanisms of antitumor effect and resistance, observe clinical antitumor responses, and monitor specific immunologic parameters appropriate to that clinical trial and approved by the Project Officer. At the conclusion of each clinical trial, the Contractor will summarize results in a written Report of Clinical Trial submitted to the Project Officer.