Clinical Protocol and Data Management

Stanford University, Stanford CA

Investigators

Linked publications, trials & patents

Abstract

PROJECT SUMMARY The Stanford Cancer Institute (SCI) Cancer Clinical Trials Office (CCTO) provides centralized support for the efficient and effective conduct of high-quality oncology clinical research. The CCTO is led by Joel Neal, MD, PhD, CCTO Medical Director, who assumed the role in January 2021 following the transition of Heather Wakelee, MD, into the SCI Deputy Director role, and Elizabeth Anderson, MPH, who was recruited as CCTO Executive Administrative Director in 2017, following the retirement of her predecessor. The CCTO offers comprehensive, centralized expertise in protocol development, scientific review, regulatory management, study coordination, data collection and monitoring, education and training, pre-award financial management, and quality assurance. Key accomplishments over this funding period include reorganization and expansion of CCTO management and staff to more effectively serve the 16 SCI Clinical Research Groups, multiple initiatives to improve CCTO staff recruitment and retention, and implementation of several high-impact technology solutions to increase efficiency and transparency of CCTO’s work. Data and safety monitoring activities were enhanced in this funding period with expanded monitoring to include all interventional studies. The SCI Data and Safety Monitoring Plan, approved by the National Cancer Institute (NCI) in November 2020, provides guidance for the conduct of cancer clinical trials in accordance with NCI Cancer Center Support Grant (CCSG) requirements. Over this funding period, the CCTO has facilitated the development and activation of 631 cancer-related interventional studies, including an increasingly complex portfolio of studies such as CAR-T and basket and umbrella trials with targeted treatment interventions. In 2020, the CCTO supported the accrual of 913 participants to interventional trials with a substantial increase of accruals to Stanford-driven investigator-initiated treatment interventional trials in 2019 and 2020 (34% increase over 2018). Notably, despite constraints posed by COVID-19 pandemic, the 2020 accruals to treatment interventional trials reflect the upward trajectory of accruals, resulting from the myriad actions taken to strengthen accrual numbers at the SCI, in accordance with the SCI Strategic Plan. The SCI is committed to serving all residents in our 10-county catchment area. Female participants accrued to treatment interventional trials closely align with the SCI population and more closely with the SCI catchment area, as does the accrual of most minority groups. The SCI has implemented new strategies to increase participation of Black/African American patients through key initiatives aligned with the SCI Strategic Plan and in close collaboration with the new SCI Office of Cancer Health Equity and Community Engagement. The SCI is actively engaged in clinical research in patients across the lifespan. In 2020, of the accruals to interventional trials, 9.2% of participants were less than 18 years of age, and 34.9% of participants were greater than 64 years of age.