Clinical Protocol and Data Managment

Indiana University Indianapolis, Indianapolis IN

Investigators

Linked publications & trials

Abstract

CPDM is led by new Associate Director for Clinical Research Tim Lautenschlaeger, MD (EDT) as of February 2025. IUSCCC adult investigators conduct clinical research at five sites: IUSCCC, Eskenazi Health, Indiana University Health (IUH) Joe & Shelly Schwarz Cancer Center, IUH West Cancer Center, and the Roudebush Veterans’ Administration (VA) Medical Center. The Adult CTO is led by Medical Director Anita Turk, MD (EDT) as of May 2025, and Administrative Director of Operations Mario Contreraz, MBA, MSN, RN, CCRC. IUSCCC pediatric investigators conduct clinical research primarily at Riley Hospital for Children. The Pediatric CTO is led Administrative Director of Clinical Research Operations Melissa Lee, BS, CCRP. These directors provide leadership and oversight of day-to-day CTO operations to ensure comprehensive, high-quality services and to streamline efforts to open clinical trials and increase accrual. In 2022, the CTO managed 330 active clinical trials, including 97 IITs, 41 (42%) of which were led by IUSCCC investigators. Over the current grant period, the CTO staff has grown by 32% (2019=93, 2022=123) to support expansion of our clinical research footprint to new locations and in recognition of the increased complexity and risk associated with managing IUSCCC-led multicenter trials and IITs. The COVID-19 pandemic brought challenges and opportunities. We maintained therapeutic accrual in 2020, but accrual dipped in 2021 as we rebuilt staff to ensure safe and compliant operations with timely data management. Overall accrual stabilized and interventional accrual exceeded pre-pandemic levels in 2022 (1484 vs. 1370 in 2019) and is poised to increase further over the next year. Despite challenges of the pandemic, therapeutic IIT accruals increased by 27% from the prior to the current grant period: CY 2013-17 (702) vs. CY 2018-22 (893). A Statewide Oncology Research Administrator position was created to launch clinical research at two new sites in the Indianapolis suburban region to support the continued expansion of oncology clinical research. In 2018, the CTO created a new patient-facing, non-licensed position, the Clinical Research Patient Specialist (CRPS), initially dedicated to supporting non-interventional trials. During the current grant period and through the natural attrition of clinical research nurses, we have expanded use of the CRPS position (n=20 currently, with five additional positions to recruit) to support select therapeutic clinical trials, increasing the financial sustainability of clinical trial operations at IUSCCC. Data and Safety Monitoring is led by Data and Safety Monitoring Committee Co-Chairs Rohan Maniar, MD (EDT), and Rita Assi, MD (EDT), along with Chief Compliance Officer Amy Graf, BS. Key activities include risk- based monitoring, auditing, and review of trial conduct. The CTO supports and encourages enrollment of participants representing Indiana’s population across age groups in clinical research. Enrollment in pediatric therapeutic studies continues to be a significant strength.