Clinical Protocol and Data Management

临床方案和数据管理 摘要 临床方案和数据管理(CPDM)在亨斯迈癌症研究所(HCI)发挥着关键作用 监督临床研究的成功实施。CPDM过程产生高效和高质量的 结果支持癌症中心履行其创建和改进癌症治疗的使命， 最终目标是减轻癌症患者的痛苦。CPDM的领导层既有行政管理部门，也有 临床专业知识，以维持卓越的临床研究文化，临床试验是最重要的 HCI患者的治疗选择。 CPDM内部最大的集中化组织是临床试验办公室(CTO，129 FTE)，该办公室拥有良好的- 明确的使命是支持HCI的介入治疗试验。首席技术官的主要目标是促进 高效完成合规临床试验，同时确保患者安全、研究完整性和简化 学习活跃度。CTO提供强大的监管、财务、临床和数据协调支持，以 人机界面社区的首席调查人员。首席技术官寻求为我们的患者提供平衡的服务组合 并涵盖罕见疾病的临床试验。目前，首席技术官监管着大约390个 积极的临床试验，照顾了1800多名临床试验参与者。 HCI为所有研究人员发起的临床试验进行数据和安全监控(DSM)，与 他们的风险水平和我们的国家癌症研究所批准的数据和安全监测计划中定义的。 监督的试验包括生理毒性和剂量发现研究(第一阶段)；疗效研究(第二阶段)；以及 疗效、有效性和比较试验(第三阶段)。 HCI致力于为我们的集水区犹他州的所有居民提供服务，包括妇女、儿童、 和服务不足的人群。我们的目标是提供特殊的护理和获得癌症的最新进展 通过参与临床研究进行治疗。人机界面保持高度的警觉，以确保 在我们的集水区，代表性不足的少数民族得到平等的照顾和临床试验的机会 我们的中心。犹他州代表性不足的群体主要分为两类：1)基于种族的少数群体， 种族和较低的社会经济地位，以及2)由犹他州组成的地理上处于不利地位的人口 农村/边境居民，他们在获得专科护理和治疗综合体方面存在重大障碍 疾病，包括癌症。在HCI的治疗试验中，未得到充分服务的少数民族的人口统计数字有所增加 我们集水区癌症人口的性别、种族和民族人口统计与 在我们中心看到的新的癌症患者的人口。

CLINICAL PROTOCOL AND DATA MANAGEMENT ABSTRACT Clinical Protocol and Data Management (CPDM) serves a critical role at Huntsman Cancer Institute (HCI) of overseeing the successful execution of clinical research. CPDM processes yield efficient and high-quality outcomes to support the Cancer Center in its mission to create and improve cancer treatments, with the ultimate goal to relieve the suffering of cancer patients. The leadership of CPDM has both administrative and clinical expertise to sustain a culture of exceptional clinical research, with clinical trials as the most important choice of treatment for patients at HCI. The largest centralized group within CPDM is the Clinical Trials Office (CTO, 129 FTEs), which has a well- defined mission to support interventional treatment trials at HCI. The primary goal of the CTO is to promote efficient completion of compliant clinical trials, while ensuring patient safety, study integrity, and streamlined study activation. The CTO provides robust regulatory, financial, clinical, and data coordination support to principal investigators in the HCI community. The CTO seeks a balanced portfolio serving our patient population and encompassing rare disease clinical trials. Currently, the CTO oversees approximately 390 active clinical trials, caring for more than 1,800 clinical trial participants. HCI conducts Data and Safety Monitoring (DSM) for all investigator-initiated clinical trials, commensurate with their level of risk and as defined in our National Cancer Institute-approved Data and Safety Monitoring Plan. Trials overseen include physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); and efficacy, effectiveness, and comparative trials (Phase III). HCI is committed to serving all residents of our catchment area, the State of Utah, including women, children, and underserved populations. We aim to provide exceptional care and access to the latest advances in cancer treatment through participation in clinical research. HCI maintains heightened awareness to ensure that underrepresented minorities in our catchment area receive equitable care and opportunities for clinical trials at our Center. Underrepresented groups in Utah fall primarily into two categories: 1) minorities based on race, ethnicity, and low socioeconomic status, and 2) geographically disadvantaged populations consisting of Utah’s rural/frontier residents, who have significant barriers to access to specialty care and treatment of complex diseases, including cancer. The demographics of underserved minorities accrued to treatment trials at HCI parallel the gender, racial, and ethnic demographics of our catchment area cancer population and the population of new cancer patients seen at our Center.