What We Do
The UNLV Office of Clinical Trials is a vital resource in supporting interventional, observational, and epidemiological research in relation to human subjects. Our office assists with review, analysis, preparation, and execution of:
- Industry-sponsored
- Investigator-initiated clinical research
- Federally funded clinical research (with OSP)
The office also supports:
- Study feasibility
- Policies and procedures
- Logistical considerations
- Central data management
- Budgetary review and negotiation, financial management
- Contractual obligations
| Internal Number | Title | Patient Population | Contact for Additional Information |
|---|---|---|---|
| 2022-004 | Pharmacokinetic Characterization and Bioavailability of Strawberry | Patients with a family history of diabetes. | Kathy Mendez 702-671-5093 |
| 2017-010 | Natural History Study Of The Development Of Type 1 Diabetes (Trialnet TN01) | Blood draw to determine if a patient may be a risk factor for patients with a family history of Type 1 Diabetes. | Kemi Otitoju 702-671-4351 |
| 2022-002 | ZEUS - Effects of Ziltivekimab Versus Placebo on Cardiovascular Outcomes in Participants With Established Atherosclerotic Cardiovascular Disease, Chronic Kidney Disease and Systemic Inflammation | Patients with cardiovascular disease, chronic kidney disease, and systemic inflammation | Kemi Otitoju 702-671-4351 |
| 2022-003 | A Pivotal Study to Assess the Safety and Effectiveness of NovoSorb Biodegradable Temporizing Matrix (BTM) in the Treatment of Severe Burn Skin Injuries | Patients with severe burn skin injuries | Kathy Mendez 702-671-5093 |
| 2019-001 | Discovery and Evaluation of Biomarkers for the Diagnosis and Treatment of Disease (Tissue) | Tissue sample collection from patients undergoing surgical removal of tumors | Kemi Otitoju 702-671-4351 |
| 2023-002 | A Randomized, Double-Blind, Parallel Group, Placebo- Controlled Multicenter Phase 3 Study to Evaluate Efficacy, Safety and Tolerability of Two Regimens of Ianalumab on Top of Standard-of-Care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1) | Patients with systemic lupus erythematosus | Kathy Mendez 702-671-5093 |
| 2023-003 | A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of Ianalumab on Top of Standard-of-Care Therapy in Participants With Active Lupus Nephritis (SIRIUS-LN) | Patients with active lupus nephritis | Kathy Mendez 702-671-5093 |
| 2023-001 | A Phase 3, Multicenter, Prospective, Randomized, Open-label Study for Intraoperative Ureter(s) Visualization When Using ASP5354 with Near-infrared Fluorescence (NIR-F) Imaging in Adult Participants Undergoing Minimally Invasive and Open Abdominopelvic Surgeries | Patients undergoing minimally invasive and open abdominopelvic surgeries | Kathy Mendez 702-671-5093 |
Affiliated Research Service Sites
In support of cross-collaboration and maintaining the feasibility of research studies, Office of Clinical Trials has established partnerships within the community that support the research and assessments necessary to meet protocol requirements.
- UNLV Investigational Drug Services (IDS) Pharmacy
- University Medical Center of Southern Nevada
- Sunrise Hospital and Medical Center
- Desert Radiology
- Quest Diagnostics
- Exam One (a Quest Diagnostic Company)
- CPL Laboratories
- LMC Pathology
School of Medicine Resources
The Kirk Kerkorian School of Medicine at UNLV has experienced clinical research coordinators that liaise with industry sponsors and provide the following service support to researchers:
- Preparation and submission of materials for internal committee reviews and initial, continuing, and amendment preparations for the internal review board (IRB).
- Site selection/qualification visits and site initiation visits.
- Protocol review and training.
- Meeting with, preparing with, and analyzing between collaborating departments/service sites.
- Investigator meetings, source documentation development, electronic data capture training, and updating the university’s clinical trials management system.
- Assisting study data monitors for site visits, audits, and subject data review.
Master Confidentiality Disclosure Agreements
To help expedite the review of protocols for interested potential investigators, the Office of Clinical Trials is currently working with sponsors/CROs to finalize general or master Confidentiality Disclosure Agreements.
Protocol Activation Process
- Investigator Identifies a Protocol
- A CDA is sent to the Clinical Trials Office at UNLV
- A Sponsor Feasibility Questionnaire is sent to the Investigator
- Protocol reviewed for feasibility by departments supporting schedule of assessments
- Scientific Merit Review Committee Review/Approval
- Budgets and Contracts
- Informed Consent Form(s) drafted
- Submit SMFRC approval letter, Initial IRB Application Packet to ORI and IRB of Record
- IRB review and Approval
- Protocol Training/Site Initiation Visit
- Protocol Opens to Accrual
- Budgets and Contracts
Investigator Initiated Protocol Assistance/Support
Office of Clinical Trials is HAPPY to help with any of the following:
- IND/IDE Application
- Phase
- Subject Population
- Schedule of Assessments required
- Protocol
- Protocol Templates based on funding source, phase, intervention, IND/IDE application, subject population, specifications and requirements of sponsor.
- Funding Source
- Industry – will work with Sponsors to obtain proper funding and contracts.
- Grants – will work with OSP to verify protocol meets all requirements.
Contact Us
Michelle Tomasino
Manager, UNLV Office of Clinical Trials
702-895-4923
michelle.tomasino@unlv.edu
cto@unlv.edu
Clinical Research Analyst, UNLV Office of Clinical Trials
mikayla.vasquez@unlv.edu
Availability
Tuesdays
UNLV Clinic (1707 Building)
2nd Floor Conference Room
Call to schedule a time.