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Principal Investigator: Tim Lautenschlaeger
Organization: INDIANA UNIVERSITY INDIANAPOLIS
Fiscal Year: 2024
Award: $316,620
Funding agency: National Cancer Institute
ABSTRACT, Clinical Protocol and Data Management (CPDM)
The Indiana University Simon Comprehensive Cancer Center (IUSCCC) Clinical Trials Office (CTO) provides
the clinical research infrastructure to support IUSCCC investigators and enhance their clinical research
productivity. The CTO provides comprehensive services to assist investigators in developing, activating, and
conducting scientifically meritorious cancer clinical trials, recruits and trains research staff, and educates clinical
investigators. At the same time, the CTO ensures the validity and integrity of data to fulfill all National Cancer
Institute (NCI), federal, and local regulatory requirements and coordinates activities with the Protocol Review
Management System, Data and Safety Monitoring Committee, IUSCCC Compliance Office, Institutional Review
Board (IRB), disease-oriented teams, and protocol sponsors. The Compliance Office reports directly to the
Associate Director for Clinical Research and monitors and audits all IUSCCC investigator-initiated trials (IITs) to
ensure subject safety, scientific validity, and data integrity. We accomplish these goals through the following
Specific Aims: Aim 1: Facilitate the efficient development, conduct, and reporting of clinical trials across the
range of therapeutic, interventional, correlative, and population-based studies by maintaining a centralized
infrastructure and educated workforce; Aim 2: Expand access to clinical trials, particularly for underserved
populations, to better reflect and serve our catchment area while reducing the time to study completion; and Aim
3: Maintain regulatory compliance, subject safety, and data quality to instill confidence in clinical trial participation
and results. Over the past funding cycle, the CTO staff has grown by 32% to support the growth and increased
complexity of clinical research at IUSCCC. We have invested in multiple organizational improvements, including
expanding the multi-center team and patient-facing non-licensed clinical research staff, increasing protocol
development services, and adding a Statewide Oncology Research Administrator. While accrual over the entire
current grant period decreased due to the COVID-19 pandemic, interventional accruals recovered and exceeded
pre-pandemic levels in 2022 (1484 vs. 1370 in 2019). Our commitment to therapeutic IITs led to a 27% increase
in IIT accrual for the current grant period (2018-22) over the prior (2013-17) grant period.
Terms: <21+ years old><Address><Administrator><Adult><Adult Human><CCSG><COVID crisis><COVID epidemic><COVID pandemic><COVID-19 crisis><COVID-19 epidemic><COVID-19 era><COVID-19 global health crisis><COVID-19 global pandemic><COVID-19 health crisis><COVID-19 pandemic><COVID-19 period><COVID-19 public health crisis><COVID-19 years><Cancer Center><Cancer Center Support Grant><Career Ladders><Catchment Area><Childhood><Children's Hospital><Clinical Cancer Center><Clinical Data><Clinical Investigator><Clinical Management><Clinical Nursing Research><Clinical Oncology><Clinical Practice Nursing Research><Clinical Protocols><Clinical Research><Clinical Study><Clinical Trials><Collaborations><Community Outreach><Comprehensive Cancer Center><Data><Data Collection><Dedications><Development><Disease><Disorder><Education><Educational aspects><Employee><Enrollment><Ensure><Funding><Generalized Growth><Goals><Grant><Growth><Health><IRB><IRBs><Indiana><Indiana University Cancer Center><Individual><Individuals from minority><Individuals of minority><Industry><Infrastructure><Institutional Review Boards><Intervention><Intervention Strategies><Investigators><Investments><Leadership><Location><Medical Directors><Medical center><Minority Groups><Minority People><Minority Population><Minority individual><Monitor><Multi-center trial><Multicenter Trials><NCI Organization><National Cancer Institute><Office Management><Oncology><Oncology Cancer><Operations Research><Patients><Pediatric Hospitals><Pharmacies><Pharmacy facility><Physician Executives><Pilot Projects><Population Study><Position><Positioning Attribute><Principal Investigator><Productivity><Protocol><Protocols documentation><Reporting><Research><Research Infrastructure><Research Personnel><Research Training><Researchers><Risk><SARS-CoV-2 epidemic><SARS-CoV-2 global health crisis><SARS-CoV-2 global pandemic><SARS-CoV-2 pandemic><SARS-coronavirus-2 epidemic><SARS-coronavirus-2 pandemic><Safety><Services><Severe Acute Respiratory Syndrome CoV 2 epidemic><Severe Acute Respiratory Syndrome CoV 2 pandemic><Severe acute respiratory syndrome coronavirus 2 epidemic><Severe acute respiratory syndrome coronavirus 2 pandemic><Site><Specialist><Students><System><Therapeutic><Therapeutic Clinical Trial><Therapeutic Studies><Therapy Research><Time><Tissue Growth><Underserved Population><United States Department of Veterans Affairs><United States Veterans Administration><Universities><Veterans Administration><Veterans Affairs><Woman><Work><adulthood><cancer clinical trial><college><collegiate><community engagement><coronavirus disease 2019 crisis><coronavirus disease 2019 epidemic><coronavirus disease 2019 global health crisis><coronavirus disease 2019 global pandemic><coronavirus disease 2019 health crisis><coronavirus disease 2019 pandemic><coronavirus disease 2019 public health crisis><coronavirus disease crisis><coronavirus disease epidemic><coronavirus disease pandemic><coronavirus disease-19 global pandemic><coronavirus disease-19 pandemic><data integrity><data management><data quality><developmental><e-Consent><eConsent><electronic consent><engagement with communities><enroll><improved><interventional strategy><investigator-initiated trial><life span><lifespan><member><oncology clinical trial><ontogeny><operation><operations><pandemic><pandemic disease><participant safety><pediatric><pilot study><population-based study><population-level study><pre-pandemic><programs><protocol development><recruit><retention rate><retention strategy><severe acute respiratory syndrome coronavirus 2 global health crisis><severe acute respiratory syndrome coronavirus 2 global pandemic><studies of populations><study of the population><subject safety><suburb><suburban><suburbia><under served group><under served individual><under served people><under served population><underserved group><underserved individual><underserved people>