CLINICAL TRIALS OF BIOLOGICAL RESPONSE MODIFIERS

承包商将进行生物反应的临床试验 癌症患者中的修饰物。与项目官员合作， 承包商将确定两项或两项以上的临床试验 合同年。被研究的药剂将由政府或 由项目官员批准的其他项目。所有临床方案都将是 提交给NCI批准的项目官员。的总目标是 合同将解决在使用中的基本问题 单抗和靶向剂在患者治疗中的应用 得了癌症。 每个临床试验都将作为以下内容的一部分进行开发、实施和分析 特定的任务顺序。至少，每个协议都将评估 治疗方案的毒性，探讨其抗肿瘤作用的机制 和耐药性，观察临床抗肿瘤反应，监测特异性 适用于该临床试验并经批准的免疫学参数 项目官员。在每个临床试验结束时， 承包商将在临床试验的书面报告中总结结果 提交给项目官员。

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.