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Principal Investigator: Thomas J. George
Organization: UNIVERSITY OF FLORIDA
Fiscal Year: 2024
Award: $169,476
Funding agency: National Cancer Institute
CLINICAL PROTOCOL AND DATA MANAGEMENT: ABSTRACT
The Clinical Protocol and Data Management (CPDM) component of the University of Florida Health Cancer
Center (UFHCC) provides comprehensive resources and quality control for the efficient conduct of clinical cancer
research relevant to our catchment area (CA), inclusive of efforts to address minorities, women, and individuals
across the lifespan. The CPDM is overseen by George (CTHR), Associate Director for Clinical Research, and
implemented by the UFHCC Clinical Research Office (CRO). UFHCC leadership and staff support clinical
research addressing the needs of the UFHCC CA, with an emphasis on access to novel therapies arising from
UFHCC research programs. The CRO facilitates the efficient conduct of high-quality clinical research through
centralized management, reporting, and quality assurance functions. The CRO offers UFHCC investigators the
infrastructure to manage a full range of investigator-initiated trials (IITs), external peer-reviewed, NCI sponsored,
and industry trials, while also facilitating and tracking non-interventional studies. The CRO meets the needs of
UFHCC members by supporting protocol development, activation, regulatory compliance, participant screening
and recruitment, investigational pharmacy interactions, clinical research coordination, data abstraction,
information dissemination, and interactions with sponsors and regulatory bodies. The CRO also provides
centralized education and training to augment data integrity and participant safety. The office administers the
UFHCC Data and Safety Monitoring Plan that delineates the structure and responsibilities of the Data Integrity
and Safety Committee which reviews and assures the safe conduct of UFHCC clinical research. The UFHCC
research portfolio emphasizes IITs, NCI sponsored studies, and other early phase treatment trials focusing on
refractory diseases, to address the disproportionate number of advanced cancer diagnoses in our CA. From
2016 to 2021, the number of active UFHCC IITs increased by 63% from 24 to 39 while the number of actively
accruing interventional protocols of all types, particularly treatment, screening, and supportive care, rose by 19%
from 162 to 192. Consistent with UFHCC priorities to support NCI sponsored trials, UF is now a voting main
member of NRG Oncology, a full member of the Children's Oncology Group, and currently the only non-NCI-
Designated center member of the ETCTN. In 2016, UFHCC accrued 515 participants to interventional cancer-
relevant clinical trials with 70% of those participants enrolling to IITs (23% on treatment IITs). With an increased
emphasis on interventional protocols and more effective patient screening, year over year increases in
enrollment occurred leading up to the pandemic. In 2021, there were 1,748 (up 3.4-fold since 2016) interventional
accruals (91% on UFHCC IITs), including 299 treatment accruals (up 2.2-fold since 2016; 59% on IITs). While
there were fewer treatment accruals due to the significant impact of COVID-19 in Florida, the UFHCC anticipates
recovery of treatment accruals with expansion of the clinical trial portfolio, enhanced participant screening
resources, and strengthened collaboration with the Office of Community Outreach and Engagement.
Terms: <Abbreviations><Address><Advanced Cancer><Advanced Malignant Neoplasm><Adverse Experience><Adverse event><Biometrics><Biometry><Biostatistics><CCSG><COVID-19 affected><COVID-19 consequence><COVID-19 effect><COVID-19 impact><COVID-19 impacted><Cancer Center><Cancer Center Support Grant><Cancer Control><Cancer Control Science><Cancer Intervention><Cancers><Catchment Area><Center for Cancer Research><Children's Oncology Group><Clinical><Clinical Cancer Center><Clinical Data><Clinical Investigator><Clinical Management><Clinical Protocols><Clinical Research><Clinical Services><Clinical Study><Clinical Trials><Clinical Trials Network><Collaborations><Community Outreach><Computerized Medical Record><Data><Disease><Disorder><ET-CTN><Early Therapeutic-Clinical Trials Network><Education and Training><Electronic Medical Record><Electronics><Enrollment><Ensure><Experimental Therapies><Florida><Health><Immune response><Immunological response><Individual><Industry><Information Dissemination><Infrastructure><Institution><Intervention><Intervention Strategies><Investigational Therapies><Investigational Treatments><Investigators><Last Name><Lead><Leadership><Malignant Neoplasms><Malignant Tumor><Methodological Studies><Minority><Monitor><NCI Center for Cancer Research><Oncology><Oncology Cancer><Participant><Patients><Pb element><Pediatric Oncology Group><Peer Review><Pharmaceutic Services><Pharmaceutical Services><Pharmacies><Pharmacy Services><Pharmacy facility><Phase><Population><Population Sciences><Principal Investigator><Procedures><Protocol><Protocols documentation><Quality Control><Recovery><Refractory Disease><Regulatory Affairs><Reporting><Research><Research Activity><Research Design><Research Personnel><Research Resources><Researchers><Resource Sharing><Resources><Safety><Science><Site><Specific qualifier value><Specified><Strategic Planning><Structure><Study Type><Supportive Therapy><Supportive care><System><Text><Training Activity><Training and Education><Translations><Underrepresented Ethnic Minority><Underrepresented Minority><Underserved Population><Universities><University adminstration><Voting><Woman><anti-cancer research><cancer diagnosis><cancer research><clinical relevance><clinical trial protocol><clinically relevant><community engagement><coronavirus disease 2019 consequence><coronavirus disease 2019 effect><coronavirus disease 2019 impact><coronavirus disease-19 impact><data integrity><data management><dissemination of results><electronic><electronic device><engagement with communities><enroll><experimental therapeutic agents><experimental therapeutics><heavy metal Pb><heavy metal lead><host response><immune system response><immunoresponse><interventional strategy><investigator-initiated trial><life span><lifespan><malignancy><member><neoplasm/cancer><new drug treatments><new drugs><new pharmacological therapeutic><new therapeutics><new therapy><next generation therapeutics><novel drug treatments><novel drugs><novel pharmaco-therapeutic><novel pharmacological therapeutic><novel therapeutics><novel therapy><pandemic><pandemic disease><participant enrollment><participant safety><patient enrollment><patient screening><pre-clinical><preclinical><programs><protocol development><quality assurance><recruit><research study><response to therapy><response to treatment><screening><screenings><sound><study design><subject safety><success><therapeutic response><therapy response><training module><translation><treatment response><treatment responsiveness><treatment trial><under served group><under served individual><under served people><under served population><under-representation of minorities><under-represented minority><underrepresentation of minorities><underserved group><underserved individual><underserved people>