DCTD Phase I/II CT PK/PD Studies

SAIC-Frederick为NIH临床中心开发治疗诊所进行的内科肿瘤学I期和II期早期临床试验的药代动力学和药效学(PK/PD)领域的实验室相关研究提供技术和物质支持。虽然其中一些标本只需要常规处理和处理，如用于分析药物水平的血浆或血清，但另一些标本需要高度专业化和立即处理，才能在以后产生有效的分析结果，例如外周血单核细胞和肿瘤活检。技术支持包括与临床工作人员密切互动所需的人员和材料，以协调从患者那里收集临床研究样本，然后将这些样本加工成稳定终点的形式，以便通过冷冻保存或专门反应进行测量。此外，PK/PD支助小组将处理后的标本打包，分发给NCI、SAIC-F或临床方案中指定的合作机构的分析实验室，或分发到储存库长期储存。PK/PD支持小组维护一个接收、处理并分发到分析站点的样本数据库，并遵循质量保证计划，以确保在处理这些来自参与开发治疗科早期临床试验的癌症患者的临床研究样本时达到尽可能高的准确性和完整性。

SAIC-Frederick provides technical and material support of laboratory correlate studies in the areas of pharmacokinetics and pharmacodynamics (PK/PD) for the Phase I and II early clinical trials in medical oncology conducted by the Developmental Therapeutics Clinic at the NIH Clinical Center. Although some of these specimens require only routine handling and processing, such as plasma or serum for analysis of drug levels, other specimens require highly specialized and immediate processing to yield valid assay results later on, for example, peripheral blood mononuclear cells and tumor biopsies. Technical support includes staffing and materials required to interact closely with the clinical staff coordinating the collection of clinical research samples from patients, and then to process those specimens into forms which stabilize the endpoints to be measured via cryopreservation or specialized reactions. In addition, the PK/PD Support Group packages processed specimens for distribution to analysis laboratories at the NCI, SAIC-F or collaborating institutions designated in the clinical protocol, or to repositories for long-term storage. The PK/PD Support Group maintains a database of samples received, processed and distributed to analysis sites, and follows a quality assurance program to ensure the highest possible accuracy and integrity in the handling of these clinical research specimens from cancer patients participating in early clinical trials within the Developmental Therapeutics Section.