DCTD Phase I/II CT PK/PD Studies

SAIC-Frederick为美国国立卫生研究院临床中心的发育治疗学诊所进行的肿瘤医学I期和II期早期临床试验提供药代动力学和药效学（PK/PD）领域的实验室相关研究的技术和物质支持。虽然其中一些标本只需要常规处理和处理，例如用于分析药物水平的血浆或血清，但其他标本需要高度专业化和立即处理，以便以后产生有效的分析结果，例如外周血单个核细胞和肿瘤活检。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，协调从患者身上收集临床研究样本，然后将这些样本处理成通过冷冻保存或专门反应稳定待测终点的形式。此外，PK/PD支持小组包装处理过的标本，分发到NCI、SAIC-F或临床方案指定的合作机构的分析实验室，或长期储存。PK/PD支持小组维护着一个数据库，包括接收、处理和分发到分析站点的样本，并遵循质量保证计划，以确保在处理这些临床研究样本时尽可能达到最高的准确性和完整性，这些样本来自参加发育治疗科早期临床试验的癌症患者。

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.