Clinical Protocol and Data Management

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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.