In July 2020, the Office of Research Affairs launched the Clinical Research Office, or CRO, to give departments access to a hybrid of virtual and traditional services that support the growth of clinical trial activities at the University of Florida College of Medicine – Jacksonville.
The patient-centered CRO has contributed significantly to the uptick in clinical research funding and other important metrics. Highlights for the college include:
- A 9% increase in overall funding of industry-sponsored clinical trials from fiscal year 2020 to fiscal year 2021.
- An 81% increase in the volume of clinical trials agreements, or CTAs, with Jacksonville-based principal investigators managed by the Division of Sponsored Programs. There were 107 CTAs in fiscal year 2021 and 59 in fiscal year 2020. The increase represents industry and federally funded/flow-down clinical trials.
- A 50% increase in the volume of industry-sponsored CTAs with Jacksonville-based principal investigators. There were 98 in fiscal year 2021 and 48 in fiscal year 2020.
- A 35% increase over fiscal year 2020 in industry-funded startup costs for clinical trials.
- An increase throughout fiscal year 2021 in industry-funded clinical trial payments, or deposits. This is primarily due to an increase in startup costs and more effective budgeting and negotiations with sponsors.
NEW SYSTEMS AND PROCESSES
The first line of action for the CRO was to create comprehensive clinical trial workflows, standard operating procedures, templates and guidelines for every aspect of clinical trial administration. That includes budgeting, negotiations and tracking of payments from sponsors.
Additionally, the CRO has implemented a new clinical trial management system called OnCore, which integrates with Epic to assist with the fiscal management of trials, the tracking of patient enrollment and other milestones. The CRO is working with departments to implement OnCore in waves. Five departments are activating OnCore. The aim is to have all of them using this resource by the end of the year.
In additional to the business side of clinical research studies, the CRO has established a new study coordinator unit, which consists of nine research coordinators who are working on clinical trials with principal investigators across different departments and specialties. Research coordinators are the backbone of clinical research. The office pledges to continue enhancing the study coordinator unit and other areas to readily assist investigators with every phase of clinical research on the UF Health Jacksonville and UF Health North campuses. The office is well equipped to assist departments and investigators with the full range of the clinical trial lifecycle, from working with sponsors and identifying clinical trials to the study closeout phase.
NEW PORTALS AND PERSONNEL
The CRO will continue its plans to further engage patients with a patient-centered portal as a resource to answer questions about studies they are enrolled in or clinical research in general. The office hopes to have physical space on the downtown and north campuses, most importantly for patients, but for faculty and staff to use as well. The office is also working on a portal for sponsors to easily access clinical and research capabilities and match sponsors with appropriate faculty members. This will expedite the feasibility and startup phase of clinical trial operations.
Last, but certainly not least, the Office of Research Affairs has recruited Lilliana Serrano to help manage CRO activities. Serrano brings vast experience in clinical research from New York University and other academic health centers. She started as a research coordinator and later moved to clinical research administration. She is well versed in every aspect of clinical research execution, administration and operations.
Visit the Office of Research Affairs’ website often, as information and resources are constantly updated and enhanced. Those include standard operating procedures, budget templates, protocol development and Institutional Review Board assistance.
Email the CRO at email@example.com if you have questions or seek more information.