Clinical Protocol and Data Management

项目总结：临床方案和数据管理 Shivaani Kummar，医学博士，临床和转化研究副总监 骑士癌症研究所（KCI）临床方案和数据管理（CPDM）的目标是提供 集中支持所有癌症相关临床和转化研究的高效和有效进行 在KCI进行的试验。KCI临床试验组合的范围涵盖了药物启动试验（IIT）， 通过国家临床试验网络（NCTN）协调行业合作和试验。CPDM 提供强大的基础设施，以支持所有试验的开发和成功管理，包括 创新和突破性的IIT。在这一基础设施的支持下，该团队成功推出了 并进行了复杂的，高影响力的IIT，如Beat AML和基于SMMART的临床试验。支助服务 包括协议设计、咨询和写作支持;预算制定和合同谈判;客户 电子数据收集表和数据库;全面的监管和IND/IDE申请支持;试验 协调和研究护理;数据管理;和临床监测的试验，还没有 一个监测实体。Shivaani Kummar，医学博士(TO)，临床和转化研究副总监， 与Eneida Nemecek，M.D.一起领导CPDM团队，M.B.A. (TO)，担任医疗主任和埃利亚娜特克， 医学博士，M.P.H.担任临床研究管理总监。CPDM的151名工作人员团队 由强大的临床研究教育和培训计划支持，支持团队成员从最初的 通过沿着职业发展道路的每一次渐进式晋升来招聘。CPDM团队已经从积极的 从2015年支持243项干预性试验到2020年积极支持374项干预性临床试验，a 增长54%。2015年，700名受试者参加了干预性临床试验，而2020年为2，853名 尽管COVID-19大流行带来了挑战，但受试者人数仍在增加， 308%的利润率。CPDM还包括由KCI数据和安全性 监测计划，由NCI于2021年4月17日重新批准。KCI致力于为我们的所有居民提供服务。 集水区，俄勒冈州，包括我们的骑士癌症合作的成员。CPDM提供 在我们的集水区，所有人群都能参与临床试验，重点是努力确定 不论种族、族裔、性别认同、性取向、移民身份， 语言熟练程度、能力、年龄或地理位置。在2020年，应计干预治疗试验从 俄勒冈州的农村地区占总应计利润的32.5%。65岁以上的成年人占37.1%， 干预性应计项目KCI继续投资于基础设施，以支持其不断发展的临床 在高质量，安全，多样性和持续的过程改进的文化研究组合。

PROJECT SUMMARY: Clinical Protocol and Data Management Shivaani Kummar, M.D., Associate Director of Clinical and Translational Research The goal of the Knight Cancer Institute (KCI) Clinical Protocol and Data Management (CPDM) is to provide centralized support for the efficient and effective conduct of all cancer-related clinical and translational research trials conducted at the KCI. The scope of the KCI clinical trial portfolio spans investigator-initiated trials (IITs), industry collaborations, and trials coordinated through the National Clinical Trials Network (NCTN). CPDM provides a robust infrastructure to support the development and successful management of all trials, including innovative and ground-breaking IITs. With the support of this infrastructure, the team has successfully launched and conducted complex, high-impact IITs such as Beat AML and SMMART-based clinical trials. Support services include protocol design, consultation, and writing support; budget development and contract negotiation; custom electronic data collection forms and databases; comprehensive regulatory and IND/IDE application support; trial coordination and research nursing; data management; and clinical monitoring for trials that do not already have a monitoring entity. Shivaani Kummar, M.D. (TO), Associate Director of Clinical and Translational Research, leads the CPDM team with Eneida Nemecek, M.D., M.B.A. (TO), serving as Medical Director and Eliana Turk, M.D., M.P.H. serving as Director of Clinical Research Management. CPDM's team of 151 staff members is supported by a robust clinical research education and training program that supports team members from initial hire through each progressive promotion along the career path. The CPDM team has grown from actively supporting 243 interventional trials in 2015 to actively supporting 374 interventional clinical trials in 2020, a growth of 54%. In 2015, 700 subjects were accrued to interventional clinical trials compared to 2020, when 2,853 subjects were accrued in spite of the challenges posed by the COVID-19 pandemic, demonstrating an increase in accruals of 308%. CPDM also includes quality and safety oversight defined by the KCI Data and Safety Monitoring Plan, re-approved by the NCI on April 17, 2021. The KCI is committed to serving all residents in our catchment area, the state of Oregon, including members of our Knight Cancer Collaborative. CPDM provides access to participation in clinical trials for all populations in our catchment area, focusing on efforts to identify opportunities for inclusion regardless of race, ethnicity, gender identity, sexual orientation, immigration status, language proficiency, ability, age, or geographic location. In 2020, accruals to interventional treatment trials from rural areas of Oregon accounted for 32.5% of overall accruals. Adults over 65 years of age represent 37.1% of interventional accruals. The KCI continues to invest in infrastructure to support the needs of its evolving clinical research portfolio in a culture of high quality, safety, diversity, and continuous process improvement.