Future Focus and Capabilities of the Clinical Research Unit Subcommittee Report

REPORT OF THE SUB-COMMITTEE ON THE FUTURE FOCUS AND CAPABILITIES OF THE CLINICAL RESEARCH UNIT

INTRODUCTION:

The Clinical Research Unit (CRU), located on the first floor of the Institute for Human Performance (IHP), is an Upstate Medical University supported specialized core facility dedicated to conducting outpatient clinical research funded by government, industry, or not-for-profit foundations. Any member of the Upstate Medical University faculty may utilize the resources available at the CRU for implementation of clinical research protocols. All projects are approved by the Institutional Review Board for the Protection of Human Subjects (IRB).

The CRU is generally open Monday-Friday 7am to 4:30 pm. When needed, it is also open evenings and weekends. The Division of Infectious Diseases in Department of Medicine, has utilized weekend hours for some of their vaccine trials. The CRU budget includes 6.1 FTE research RNs. These nurses work for the hospital as assigned when not needed on the CRU. RNs are paid by University Hospital (including overtime for weekend hours for vaccination trial visits). The research support specialist/laboratory technician, laboratories research nurse practitioner and space are supported by Research Administration.

UTILIZATION:

In 2019-2020, investigators from the following departments used the CRU: Geriatrics (1 faculty), Medicine [Endocrinology, Diabetes and Metabolism (3 faculty), Infectious Diseases (4 faculty), Rheumatology (1 faculty)], Microbiology/Immunology (1 faculty), Neurology (6 faculty), OB/GYN (1 faculty) Orthopedic Surgery (1 faculty), Pediatrics (Endocrinology and Diabetes, 1 faculty), and Psychiatry (1 faculty). There were 1,656 study visits, some of which were quite brief and others lasting up to 12 hours. The most visits were conducted for studies in Geriatrics (135), Endocrinology, Diabetes and Metabolism (561), Infectious Diseases (747) and Neurology (129).

PI PERSPECTIVES:

Benefits:

• Research nurses are excellent, professional and treat participants with empathy and respect.

• Research laboratory services (laboratory technician, processing, storing and shipping of samples) are excellent.

• The CRU really has most everything needed to make any investigator successful. The focus is research, unlike clinics, which are much busier and less detail-oriented.

• Ability to conduct complicated and long assessments and procedures

• Ability to administer investigational products

• Space for monitoring visits Barriers:

• Clinical faculty need protected time. Time devoted to research takes time away from seeing patients and results in a significant reduction in salary.

• Location (in the IHP) is inconvenient (too far from patient care sites)

• Lack of training programs for trainees and inexperienced faculty

• Paucity of experienced mentors

• Training for research APP needed for specific procedures. For neurology and geriatrics research, lumbar puncture training was given as an example.

• Some new faculty report they were not aware of the CRU and services provided.

• Some faculty have need for CRA services (including part-time), including help with IRB/regulatory.

• Difficulty with participant recruitment for some studies

• Limited number of exam and procedure rooms, which need to be cleaned before and after each participant by a nurse, can restrict scheduling.

• Location not connected to the hospital (limits types of studies that can be performed safely and makes use of the research pharmacy logistically difficult)

• No inpatient capability (not in a hospital)

• No clerical support for registration, scheduling, billing (including required entries into the CTMA (Velos))

• Difficulty scheduling other needed ancillary services (e.g., imaging studies)

PLAN:

To increase the footprint and capacity of the CRU, the following are recommended: General:

• Include introduction to the CRU during faculty recruitment and orientation

• Recruitment of clinical researchers who can also serve as mentors and help establish training programs

• Improve visibility/access to CRU site on Upstate’s research website Outpatient:

• Establish satellite CRU in the Nappi building

• Establish satellite site at either 550 Harrison or UHCC. This would facilitate collaborations with Ophthalmology, which has all its equipment at 550.

• Expand use of satellite site at Community (Global Health is already planning to do studies there - possibly others can use that site; a needs assessment should be performed to determine faculty interest).

• To facilitate the conduct of clinical trials for both new and established investigators, the CRU should employ a staff member who will register subjects when necessary, enter completed procedures into the CTMS (Velos) after each visit, work with study staff and CRU nurses to prepare visit orders, and schedule CRU appointments in EPIC.

• Have satellite research pharmacy or pharmacist services on site

Inpatient: The establishment of an inpatient research unit at the Community campus: Global Health uses inpatient beds on the sixth floor of Community to admit people as needed for their dengue fever study. It was proposed that designated hospital space on the Community campus be used for research (and for nonresearch patient care when not needed for research). This would permit additional studies to be conducted (e.g., 24 hour/multiday PK studies, additional inpatient vaccination (challenge) studies, and epilepsy studies by Neurology).

ASPIRATIONAL GOALS:

In 5-10 years, the goal is to submit a successful Clinical and Translational Science Award (CTSA application) to the NIH (UL1 and KL2 awards required). For the UL1 award the following are required: A. Administrative Core; B. Informatics; C. Community and Collaboration; D. Translational Endeavors; E. Research Methods; F. Hub Resource Capacity, G. Network Capacity. An Institutional Career Development Core (KL2), which supports early career postdocs and physicians, is also required. A TL1 award is optional (National Research Service Award Training Core to support translational research training for pre- and postdoctorates). See PAR-18-940 for further details.