On May 20, National Clinical Trials Day, UVA School of Medicine will celebrate the development of a new, full-service Clinical Trials Unit (CTU) to help UVA School of Medicine, UVA Health, and UVA achieve our shared mission of research excellence. Leading research and translational impact is a key initiative of the “enabling discoveries for better health” goal of UVA Health’s strategic plan.
From left, part of the new Clinical Trials Unit: Clinical Research Coordinators Alexandra Stauffer, Tam Le, and Madison Focht; and CRC Manager Susan Hamil, RN, CCRC. (Photo by Robert Banks.)
Clinical research coordinators (CRCs), principal investigators (PIs), and anyone interested in clinical trials are invited to attend a celebration and informational fair on May 20, 10 a.m. – 2 p.m. in Pinn Hall, Room 2ABC. The event includes a light breakfast and lunch, raffles, and opportunity to meet CTU office staff. Melina Kibbe, MD, dean of the School of Medicine and chief health affairs officer and Linda Duska, MD, associate dean for clinical research will provide remarks at 1 p.m.
Expansion of Services
The CTU provides an enhanced, centralized infrastructure to support researchers in a methodologically sound, compliant, efficient, and cost effective way as they develop and execute high quality, human subject research. While some services already existed to support the research community, an expansion of services such as the ones listed below led to the development of CTU:
- Clinical Research Coordinators: A new pool of trained research coordinators available for “hire” on a part-time basis to assist investigators in clinical studies.
- Regulatory Services: A new offering that focuses on regulatory start-up and management support for drafting and completing documents required for study initiation, and for maintaining regulatory documents throughout the clinical study.
- Finance and Budget Services: Financial management including support for budget development, clinical trial billing, and sponsor invoicing.
Translating Discoveries into Revolutionary Therapies
Linda Duska, MD, MPH
“Clinical research allows us to offer novel therapies and treatment options to our patients, while also paving the way to more effective and potentially better tolerated therapies in the future,” explains Linda Duska, MD, MPH, Associate Dean for Clinical Research, Lawrence W. Penniston, MD, Family Endowed Professor of Women’s Oncology Research, UVA School of Medicine. The CTU aims to:
- Remove barriers and streamline processes for PIs, enabling them to dedicate more attention to their research endeavors.
- Eliminate obstacles to more clinical trials for faster speed-to-market — potentially leading to increased research output and the development of more novel treatments accessible to more patients.
- Provide clinical research support to PIs who don’t have the access to an infrastructure to support full-time research staff.
- Supplement existing research staff so they have time to recruit and enroll more subjects.
- Fill in when existing research staff is out for an extended period and when timelines are sped up.
“The CTU will create a clinical research infrastructure allowing researchers without these resources to be successful in clinical research, while at the same time continuing support of all researchers across the University in their clinical research efforts,” adds Lori Elder, RN, BSN, CCRA, Director, UVA School of Medicine Clinical Trials Office.
Cornerstone of Evidence-Based Medicine
Clinical trials allow the development of safe and effective treatments and identify the patients who will benefit the most. By choosing to participate in clinical trials, volunteers have access to potential new treatments as they’re being developed — sometimes years before they become widely available. After the treatments are FDA-approved, we’re positioned to be among the first to offer them.
Novel Treatments
Our research and clinical trial work has led to novel treatments such as focused ultrasound for essential tremor and the artificial pancreas for diabetes. The Paul and Diane Manning Institute of Biotechnology also is part of our commitment to developing new and better treatments.