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2020 clinical research by the numbers

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.

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2,108 participants enrolled in studies

 

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1,403 VCU and VCU Health study team members

 

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885 studies active during the year

 

 

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576 multi-site studies

 

 

 

183 studies opened

 

 

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43 COVID-19 studies opened

 

 

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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.

 

 

Zero to Sixty: The Wright Center’s rapid response to COVID-19

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.

Arun Sanyal, M.D.

By late March, Wright Center Associate Director Arun Sanyal, M.D., had partnered with Gilead to bring remdesivir treatment trials to VCU. And on May 1, armed with data that VCU’s trial helped provide, the FDA issued emergency authorized use of the drug.

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:

F. Gerard Moeller, M.D.
  • 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.

Antonio Abbate, M.D., Ph.D.

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.

The Wright Center’s informatics team, under the leadership of Tamas Gal, Ph.D., MBA, which helps compile and analyze clinical data, has re-oriented their programming projects toward registries, surveys, portals and application processes, like a survey for those who might’ve noticed a change in their smell or taste abilities – one of the virus’ symptoms.

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.

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The 3D-printed ventilator created by an interdisciplinary team connected by the Wright Center. (Photo courtesy of Trevor Beck Frost)

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.

OVPRI, in collaboration with the Wright Center, is foregoing certain typical licensing fees during the pandemic in order to facilitate the research and development that will help combat COVID-19 collaboratively.

Annual Clinical Trials Day took on a new meaning this year, as the community rallied around healthcare providers. A COVID-19 patient in a trial run by Abbate told her story, and Abbate, Joan Greer, and Lauren Harris discussed clinical trials for a public audience.

Similarly, Wright Center researchers have acted as experts for media outlets – providing a crucial science-based perspective for the community during this public health crisis. Among others:

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.

Many studies have adapted using telehealth technologies that Wright Center has led the way in. Richard Sterling, M.D., whose research has been heavily supported by the Wright Center, spoke to VCU News about telehealth in the time of a pandemic, as doctors and patients sought alternatives to in-person visits and checkups.

Suffice it to say, the Wright Center has made VCU’s rapid response to COVID-19 possible – in more ways than one.

Research Expo 2017

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

Lydia Klinger, Director of Business Operations-Wright CCTR

 

 “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!

Contact Info: Meghan Wright-wrightmk2@vcu.edu, (804)-828-4996, Lydia Klinger-lydia.klinger@vcuhealth.org, (804)-628-0245

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 

Tim Aro, Manager Informatics-Wright CCTR

“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.

Contact Info:  Tim Aro- timaro@vcu.edu, 804-628-4795 and Bobby Moulden- rbmoulden@vcu.edu, 804-628-1991