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执行。CPDM工艺生产效率高、质量高 结果，以支持癌症中心在其使命，创造和改善癌症治疗，与 最终目的是减轻癌症患者的痛苦。CPDM的领导层既有行政职能， 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 为患者选择治疗方案。 CPDM内最大的集中组是临床试验办公室（CTO，129名FTE），该办公室拥有良好的 明确了支持HCI介入治疗试验的使命。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 研究激活。CTO提供强大的监管、财务、临床和数据协调支持， HCI社区的主要研究人员。首席技术官寻求一个平衡的产品组合， 包括罕见病临床试验。目前，CTO负责管理约390家 积极开展临床试验，为1,800多名临床试验参与者提供护理。 HCI对所有制药商发起的临床试验进行数据和安全性监测（DSM）， 他们的风险水平，并在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。 监督的试验包括生理毒性和剂量探索研究（I期）;疗效研究（II期）;以及 疗效、有效性和比较试验（III期）。 HCI致力于为我们的集水区，犹他州，包括妇女，儿童， 和服务不足的人群。我们的目标是提供卓越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。HCI保持高度的意识，以确保 在我们的集水区，代表性不足的少数民族得到公平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，和低社会经济地位，和2）地理弱势群体组成的犹他州的 农村/边境居民，他们在获得专科护理和复杂的 疾病，包括癌症。在HCI的治疗试验中， 平行的性别，种族和民族人口统计学我们的集水区癌症人口和 新的癌症患者在我们的中心看到的人口。

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.