The researchers and study teams that make clinical research happen at VCU have gone above and beyond this year. They worked quickly to adapt ongoing research. They started new studies hoping to contribute to knowledge of COVID-19. They joined national and international studies. And they continued their important research on all the other diseases that didn’t take a break during the pandemic.
The Wright Center crunched the numbers on VCU researchers’ work this year.
2,108 participants enrolled in studies
1,403 VCU and VCU Health study team members
885 studies active during the year
576 multi-site studies
183 studies opened
43 COVID-19 studies opened
36 departments represented
Thank you to all the clinicians, researchers and study teams that make clinical research at VCU possible.
Numbers current from OnCore as of Dec. 9, 2020. Special thanks to Robert Moulden, manager of clinical trials management systems at the Wright Center.
The Wright Center has been on the front lines of the battle against COVID-19 since March.
As Virginia Commonwealth University’s home for interdisciplinary human health research, the center is uniquely positioned to act as a bridge between the physicians, faculty, researchers and staff that are engaged in fighting the pandemic on multiple fronts.
And it’s done just that.
Before the government-mandated shutdown took effect, several proposed projects had been uploaded to VCU’s research management system run out of the Wright Center, OnCore. And center staff had activated to help shepherd protocols through the Institutional Review Board and other processes.
The Wright Center has worked diligently to prioritize and fast track other drug treatment trials based on the best available science and the drugs’ potential for large-scale efficacy. The center’s director, F. Gerard Moeller, M.D., leads a committee with several other center faculty that works to assess and evaluate proposed COVID-19 trials.
At least seven COVID-19 drug treatment trials have activated, many in record time. Trials that might take months to get off the ground have found approval within days, thanks to the Wright Center and staff at the Office of the Vice President for Research and Innovation (OVPRI).
Wright Center Associate Director Antonio Abbate, M.D., Ph.D, is a lead on two studies that tackle the dangerous inflammatory response that COVID-19 patients sometimes experience:
Sarilumab, which was developed for rheumatoid arthritis, and
Canakinumab, which was developed to treat a series of rare auto-inflammatory diseases and a type of juvenile arthritis.
Benjamin Van Tassell, Pharm.D., a former KL2 scholar and now a member of Wright Center’s KL2 Oversight Committee, is involved in the latter trial. His and Abbate’s long-standing research into inflammation, supported in part by the Wright Center, has been crucial to VCU’s ability to bring cutting-edge treatment to its patients during COVID-19.
In May, with the help of Wright Center Clinical Research Unit staff, clinical trials for some of the experimental COVID-19 treatment drugs were expanded to VCU Health’s Community Memorial Hospital in South Hill, Virginia, expanding access to those drugs.
In addition to the drug treatment trials, the Wright Center has worked to fast track projects like a potential treatment for COVID-19 using the plasma of coronavirus survivors. More than a dozen registries for analyzing COVID patient data and vitals are underway. And multiple technologies and devices that fill critical equipment needs are in development or pending approval.
Feeding all this new research is an influx of funds flowing toward virus-related projects.
The Wright Center contributed $100,000 to the OVPRI’s COVID-19 rapid research funding opportunity, which has yielded grant awards to 31 recipients, including several clinical and translational science projects. Wright Center KL2 Scholar Guizhi “Julian” Zhu, Ph.D., was one of those recipients, for his work on a simple, at-home vaccine delivery mechanism.
The Wright Center staff and research administrators continue to contribute the research infrastructure and compliance expertise to projects that seek to fill worldwide gaps in equipment supply.
The Wright Center was instrumental in connecting interdisciplinary researchers and clinicians for a 3D-printed ventilator, the plans for which will be made freely available. And Wright Center Researcher Stephen L. Kates, M.D., helped develop a sterilization pilot program to safely decontaminate N95 masks for VCU Health employees.
Much of the research that was underway when COVID-19 hit has been paused, and the Wright Center worked with OVPRI to create research continuity guidance, so that researchers would have some template for adapting their important work.
Come to the Research Expo and find out how the Wright Center for Clinical and Translational Research can help you! The sessions are divided into two tracks that will run concurrently. The Wright Center’s Lydia Klinger and Tim Aro will be presenting the following sessions that day. Come and check it out!
Session Title: First Look: Wright Center Clinical Research Coordinator Education & Training Program
Presenters: Meghan Wright – IRB Training & Education Manager; Lydia Klinger –Director of Business Operations, Wright Center for Clinical and Translational Research
“I’m excited the Wright Center is taking such a central role in establishing programs that will promote the role of clinical research coordinators, both by providing them with standardized and robust training opportunities, and by being an advocate for their professional development and recognition.”
Session Description: While clinical research coordinators at VCU share many of the same responsibilities, training and education has historically varied from department to department. This session offers you a first look at the Wright Center’s CRC Education & Training Program, a collaborative initiative designed to provide a comprehensive, standardized approach to support quality clinical research at VCU. With robust resources, multiple training mechanisms, and tools to support clinical research coordinators and their supervisors, this program is designed to meet everyone’s needs. Come get a sneak peek at what the CRC Taskforce has up its sleeve for 2018!
Session Title: Informatics Tools and Services Supporting the Clinical Research Life Cycle
Presenters: Tim Aro, Manager – Clinical Research Informatics; Bobby Moulden, Manager – OnCore Clinical Trial Management
“Our goal is to provide the tools and services to allow investigators to focus on the science. Let the Wright Center help you with the technical aspects so scientists can focus on their research and bring new treatments to patients.”
Session Description: The Wright Center for Clinical and Translational Research will present a variety of informatics tools and services and describe how they can help support the clinical research life cycle. This pragmatic presentation will discuss technologies that can be leveraged during various phases of the clinical trial life cycle. Find out how informatics resources can help with study design/feasibility, multi-site collaborations, work flows, recruitment and trial management, electronic data capture solutions, and more.
Robert “Bobby” Moulden, manager of Clinical Trials Management System for the VCU Wright CCTR, led this presentation with a particular focus on Online Collaborative Research Environment (OnCore), which is a Clinical Trials Management System (CTMS) designed specifically for large academic medical centers with vibrant, expanding clinical research programs. The event received a large turnout with representatives from the VCU Department of Pathology, VCU Massey Cancer Center, VCU Department of Neurosurgery, and the VCU Department of Internal Medicine, among others in attendance.
OnCore is a web-accessible, centralized database with role-based security. It provides a platform to track clinical research studies and participants, and includes features such as audit/monitoring capabilities, electronic case report forms (eCRFs), and custom reporting. Additionally, patient research participation is now shared from OnCore to Cerner through an integration.
Moulden and his team reviewed OnCore’s audit console, which supports a standard institutional audit process and incorporates input provided by the VCU Office of Research and Innovation’s Clinical Research Compliance Program, the Institutional Review Board, and VCU Massey Cancer Center.
“OnCore helps coordinators work together on the most up to date forms and information,” Moulden said. “It eliminates the need for teams to email files back and forth and provides a secure platform for materials containing patient health information.”
Tim Aro, information systems manager for the CCTR’s Biomedical Informatics Core (BIC), led a presentation on the various tools and services the BIC has available to help the VCU community improve and expand data management processes.
“All of us here today have different experiences and expertise and I really think we can learn a lot from one another through collaboration,” Aro said. “The Biomedical Informatics Core is continuously growing and looking for feedback on the way you use our tools and services.”
The presentation covered an overview of the many tools and services offered by BIC, including electronic data capture (e.g. REDCap), cohort discovery (i2b2 and other new initiatives), and Clinical Trial Management System (CTMS) support and training (OnCore).
To download Tim’s full presentation slides, click here.
The next BIC Brown Bag Lunch seminar will take place Friday, April 29. Michael Tran, information technology specialist for the CCTR’s Biomedical Informatics Core, will break down REDCap (Research Electronic Data Capture), the IRB approved/recommended site that allows users to build secure web-based databases and surveys, export data to common data analysis packages, and much more.