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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.

 

 

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Wright Center Director contributes to public health messaging on vaccines

As the nation gets closer to authorized COVID-19 vaccines, VCU Health is gearing up to be part of the unprecedented distribution in central Virginia.

Wright Center Director F. Gerard Moeller, M.D., joined other researchers and health care providers to offer fact-based perspective on the safety and efficacy of vaccines for a story in VCU Health News.

“I’ve been doing clinical trials and clinical research for over 20 years,” said Moeller. “My experience with the FDA is that they have safety and efficacy at the top of their minds. People have been working there a long time through different administrations, and while they might change slightly in their approach to things, I have never seen them change their approach to safety and efficacy.

Read more at VCU Health.

MCV Foundation’s NEXT magazine features Wright Center researchers, studies

The latest issue of MCV Foundation’s NEXT magazine is out, and the Wright Center plays a big role. The issue focuses on COVID-19 research and highlights the innovation and resourcefulness shown by VCU researchers, including many from the Wright Center and those funded by center grants.

Director F. Gerard Moeller, M.D., and the Wright Center frame the lead story, “The Great Shake Up: How COVID-19 upended and refocused research at VCU Health.”

“Our researchers and administrators really stepped up to the plate in every way,” Moeller told NEXT. “It’s not a scenario that individual researchers can really plan for, but they have really managed it well.”

Also featured in that story are:

  • John Ryan, Ph.D., a professor of biology who serves on the Wright Center’s Operations Committee
  • Somaya Albhaisi, M.D., whose COVID-19 registry is funded in part by the Wright Center
  • Translational Scholar Caitlin Martin, M.D.

Other Wright Center leaders and researchers featured in stories include:

  • Arun Sanyal’s, M.D., in “Remdesivir: Establishing a Standard of Care for COVID-19”
  • Antonio Abbate, M.D., Ph.D., and Benjamin Van Tassell, Pharm.D., in “Calming the Cytokine Storm of COVID-19”
  • VCU Massey Cancer Center Director Robert Winn, M.D., in “Access & Equity: Combating Health Disparities and COVID-19 through Community Engagement”
  • KL2 Scholar Julian Zhu, Ph.D., in “Big Things in Small Packages”
  • Stephen Kates, M.D., in “Amid Crisis, Inventing Solutions”
  • Alpha “Barry” Fowler III, M.D., in “Follow up: Applying Previous Research to the Current Crisis”

And Kathy White, who serves on the COVID-19 Clinical Trials Oversight Committee, shared her experience surviving COVID-19 and participating in a clinical trial led by Abbate.

Read NEXT here.
Or download the pdf.

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VCU joins national trial testing three new drugs for COVID-19

As a Clinical and Translational Science Award hub, the Wright Center was key to bringing a new clinical treatment trial for COVID-19 to VCU Health. Arun Sanyal, M.D., the education core director at the center, will lead the ACTIV-1 trial, testing three immune modulator drugs on people hospitalized with COVID-19.

“The hope is that these drugs might restore balance to the immune system,” said trial lead Arun Sanyal, M.D., a professor in the Department of Internal Medicine in the VCU School of Medicine. “The cytokine storm can lead to respiratory distress, organ failure and other life-threatening complications, so a drug that counteracts these symptoms could reduce fatalities, shorten hospital stays and lessen the need for ventilators.”

Read more at VCU Health news.

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NASH and pericarditis: Wright Center researchers co-author two NEJM articles

New England Journal of Medicine logoTwo leaders at the Wright Center are co-authors on articles in the New England Journal of Medicine this month.

Arun Sanyal, M.D., associate director for KL2 Career Development at the Wright Center, contributed to research showing the effects of semaglutide, a medication used to treat diabetes, on nonalcoholic steatohepatitis (NASH), a disease that affects millions of people in the U.S. each year.

Published Nov. 13, “A Placebo-Controlled Trial of Subcutaneous Semaglutide in Nonalcoholic Steatohepatitis” reports on a phase 2 trial of patients with confirmed cases of NASH. The study showed that treatment with semaglutide resulted in a significantly higher percentage of patients with NASH resolution than in those who received the placebo.

The research was presented at a recent virtual conference of the American Association for the Study of Liver Diseases, where Sanyal also presented a field overview of the NASH landscape and recent clinical trial results. Sanyal leads and is part of multiple research projects on NASH at VCU, some showing promise for the treatment of the disease, which is the leading cause for liver transplantation in the U.S.

Antonio Abbate, M.D., Ph.D., associate director of hub research capacity at the Wright Center, contributed to research testing the safety and efficacy of an anti-inflammatory medication, rilonacept, on the rare disease of pericarditis.

Published Nov. 16, “Phase 3 Trial of Interleukin-1 Trap Rilonacept in Recurrent Pericarditis” reports that the drug was effective in 96% of patients with recurrent pericarditis. There are currently no FDA approved therapies for pericarditis. Read the Cleveland Clinic’s press release about the research.

Results of the study were presented at the American Heart Association’s recent Scientific Sessions. Abbate has spent many years studying heart diseases like pericarditis, exploring the link between heart conditions and inflammation.

Both Sanyal and Abbate have continued their research into heart and liver diseases this year, while leading and guiding clinical trials into the treatment of COVID-19.

Omar Abubaker speaking at a symposium in March 2019

Memorial lectureship on opioid crisis will honor VCU professor’s son

A new lecture series at Virginia Commonwealth University will address the opioid crisis, honoring the son of a VCU professor who died of an overdose.

The Adam Abubaker Memorial Lecture will bring experts and leaders together annually to focus on topics related to addiction medicine. Lecturers will present on prevention, treatment, and community health in a way that enhances the knowledge and understanding of addiction and substance use disorders.

Adam Abubaker was the son of Omar Abubaker, D.M.D., Ph.D., chair of oral and maxillofacial surgery in the VCU School of Dentistry. Adam was prescribed narcotics for pain after a high school shoulder injury, and Abubaker believes this led to his son’s heroin addiction and eventual overdose.

“Doctors and dentists, including myself, were part of this opioid epidemic,” Abubaker told VCU News last year. Since his son’s death in 2014, Abubaker has dedicated himself to spreading awareness of the dangers of opioids and over-prescription. The memorial lectureship will continue that work.

The Department of Psychiatry at the VCU School of Medicine will host the lectureship. Wright Center Director F. Gerard Moeller, M.D., is the division chair for the department and the director of the VCU Institute for Drug and Alcohol Studies.

“The opioid epidemic hasn’t gone away during the COVID-19 crisis,” said Moeller. “In fact, the pandemic is making the problem worse, as we’re seeing a surge in opioid overdoses. This lectureship will be a great addition to our addiction research and education programs at VCU – and an appropriate memorial for Adam and others who have died as a result of opioid addiction.”

To fund the lectureship, the MCV Foundation is raising a minimum of $100,000 to permanently endow it. Anyone interested in contributing to fundraising efforts for the lectureship can complete an MCV Foundation pledge form.

“We’ve got work to do”: Health Equity series explores lung disease disparities

This year, COVID-19 has disproportionately attacked the lungs of Black and Latino people. But inequities in lung health are nothing new to researchers, patients and health care providers in minority communities.

Those lung health disparities were front and center on Tuesday for Black Lives, Black Lungs, when attendees from Virginia Commonwealth University, VCU Health and the Virginia community joined lung health experts for presentations on the latest research and a conversation about paths forward.

Hosted by the C. Kenneth and Dianne Wright Center for Clinical and Translational Research, the event was the first in a quarterly series that will bring people together in an effort to address pressing concerns in health equity.

Patrick Nana-Sinkam, M.D., chair of the Division of Pulmonary Disease and Critical Care Medicine at VCU Health, presented at Tuesday’s event on current research in lung health.

Black people have the highest rates, deaths and hospitalizations for asthma. There are large disparities along racial and gender lines in the diagnosis of chronic obstructive pulmonary disease (COPD). And at-risk Black people are less likely to be screened early for lung cancer, and Black men with lung cancer are likely to die sooner than white patients.

Virginia, Nana-Sinkam noted, still has work to do in increasing screening rates among eligible patients. Only 5% of people determined to be at risk for lung cancer had screenings – a number he called “appalling.” As a non-invasive procedure, covered by insurance, he urged that it be far more common.

“To determine screening eligibility, we need to look beyond people’s age and how much they smoke,” he said.

Rita Miller of the Virginia Department of Health presented at the event.

Rita Miller of the Virginia Department of Health highlighted the marketing tactics used by tobacco companies in Black communities. “In the U.S., 90% of African-American smokers use menthols,” she said. “Tobacco companies privately studied generations of smokers. Much of what we’re just now learning, they’ve known for a long time.”

Miller screened a short film on the topic and touted the commonwealth’s Quit Now Virginia program. Its services include a patient referral portal for doctors. And she presented on FDA-approved nicotine replacement therapies and non-nicotine medications that help people quit.

Nana-Sinkam also highlighted promising treatments that individualize treatment and programs that create meaningful community partnerships. He encouraged health professionals to engage in policy on topics like environmental quality and access to health care. And he encouraged clinical trial enrollment of underrepresented populations.

Health care providers and institutions, Nana-Sinkam said, have to do more to get out in the community and serve as a credible voice in cancer prevention. The complexity of the factors involved can be daunting.

“But it’s really not about us,” said Nana-Sinkam, the associate director for career development and mentoring at Wright Center and researcher at VCU Massey Cancer Center. “The reality is we’ll have to reach out to people on a number of levels, partnering with communities to better understand the complexities of these issues.”

Robert Winn, M.D., director of the Massey Cancer Center, also gave a call to action for health care providers and community leaders, urging them to reimagine health research as integrated with the people it affects.

“The pursuit of academic excellence, while good, leaves many of our communities out in the cold,” he said. “How are we going to ‘be woke’ in our research, in order to ensure our work impacts the community in an academically relevant way?”

Treatment, in addition to considering genomics, should consider the “community-omics” of a patient, Winn said. That means taking the context of a person’s built environment and socioeconomic factors into account. Lung Health disparities, he added, are a “failure of the system.”

The event closed with a community discussion about next steps, places for growth and collaborative opportunities.

“We’ve got work to do,” said Winn, citing the partnership between Massey, the Wright Center and other VCU entities as a good start.

You can watch the Nov. 10 event online. The next Health Equity event will be February 9, 2021, and focus on prostate and colorectal cancers. Learn more and register online.

What is natural language processing? Six questions with Amy Olex

The machines are learning. But that’s OK, because Amy Olex, M.S., is there to teach them.

The senior bioinformatics specialist at the Wright Center is extracting de-identified information from troves of clinical notes so that health researchers at VCU and VCU Health can create meaningful studies and bring research results to patients more quickly.

Natural language processing (NLP) is her specialty, and she is here to help us understand it.

What is the technology behind NLP text analysis and when did it come about?

NLP’s been around for a little while, but the algorithms and science have improved. It started in linguistics, analyzing properties of texts, looking at frequencies of word distributions. The earliest NLP application that became widely available is your digital spellcheck. From there, it’s grown to where now it can predict your sentences. You have NLP applications that can write actual papers that get accepted to journals.

NLP in recent years has really taken off because of the ability to store and process massive amounts of information. We haven’t had the capacity until recently. That’s why Google is so advanced, because they’ve had this massive database of text, and they have the ability to run statistics and machine learning algorithms over it and process all the linguistic patterns from everybody that enters data into their system. That’s how you get text prediction in Gmail. Now, more of us have the technology to store and process large volumes of data.

Before we had all of that data available, NLP algorithms were rule-based, based on manually written rules. So, if you’re looking for terms associated with cancer, you build out manual dictionaries of all the different ways the word ‘cancer’ can be represented in clinical notes. Then you’d have expressions and rules go through the text and find those patterns that you manually specified. Honestly, rule-based systems are still very popular because they’re very easily interpretable. When they miss something, we immediately know why. ‘Oh, we didn’t have a rule for that instance.’

Now, with machine learning, when you’re using the large datasets and something is wrong, you don’t necessarily know why it found what it found. It’s a black box. Clinicians don’t like black boxes, especially when you’re pulling out medical concepts. It’s gotten a whole lot better over the years, for sure. But that’s an active research field, trying to figure out these machine learning algorithms and how they’re making decisions as to what is, for example, a cancer concept and what is not.

What’s a typical research project that you might employ NLP for?

Photo of Amy Olex smiling wearing a red short-sleeved blouse and square-rimmed glasses
Amy Olex, M.S., is the Wright Center’s senior bioinformatics specialist.

One of the most frequent types of projects are extracting de-identified concepts or information from the unstructured clinical notes that is not stored in the structured Electronic Health Record (EHR) data. In structured EHR data, there are set fields and values, so there’s a specific line for ‘blood pressure’ and a space for the clinician to enter those numbers.

But if, say, a doctor types up a narrative of a person’s history, with all their symptoms and their symptom progression, that’s not going to be in the structured EHR data. That’s going to be an unstructured blob of notes.

For example, in cancer research, they’d want to pull out notes on a tumor’s stage. A lot of the time, tumor stage is written into the unstructured, narrative text. But some of that information may actually be important to defining the cohort for a clinical trial or for your study. You’re going to want to pull out those notes and put them into a structured database for processing, to extract specific terms, measurements, etc. and discretize it into structured data.

Fifty years ago, how might a researcher have conducted a study where they knew there was important information they needed inside clinical notes?

Manually going through the notes! They would pull out the information by hand, and honestly, they still do that to this day, because NLP is not widely available. And it’s still not generalizable, especially in the clinical domain. Before NLP, if you needed stuff that was in written text, you hired students to dig through the data and pull out the information you needed.

How has NLP played into COVID-19 research?

There’s a group of informatics people like myself working with NLP as part of the National COVID Cohort Collaborative (N3C), a national, centralized data resource for researchers studying COVID-19.

The NLP group is working to build out the algorithmic infrastructure that a researcher could use to study, not only COVID-19, but how it interacts with comorbidities like obesity or depression, where descriptors for those conditions are not going to be in the structured text. It will be very impactful, once we can get that additional information to the N3C repository.

How does being at a Clinical and Translational Science Award (CTSA) institution matter when it comes to NLP work?

It’s a big advantage. The Wright Center is like a large networking hub. We have connections on the medical campus. We have connections on the academic campus. So, working in NLP, I have access to the clinical data that someone on an academic campus does not have easy access to, and I have access to the clinicians who understand that data. But I also have access to those in College of Engineering’s Department of Computer Science, who develop the NLP algorithms and are really knowledgeable with machine learning.

I’m not a clinician. I came from a computer science background. So when I’m working on a project that’s dealing with a specific type of condition like cancer or depression, I need access to subject matter experts to figure out what concepts I need to pull out. What’s important for differentiating patient A from patient B?

That network all at one university is a really valuable thing to have for any researcher that comes to us. I’ve had researchers on the clinical side, and I’ve connected them with people on the academic side, and vice versa. The Wright Center is a bridge between worlds – two worlds that sometimes speak different languages. And researchers need to know that it’s here, and they can take advantage of it.

What else would you want a researcher to know about NLP and how it can help them?

NLP can be very powerful. It can do a lot of cool things, but it’s still not easy. The projects require very close collaboration between me, who’s the coder and the one developing the algorithm, and the PI in charge of the research. The PI understands the clinical background to the problem they’re studying.

NLP is not a quick ‘Hey, I need these concepts.’ It’s ‘okay, you need these concepts. Our pipeline isn’t set up for that right now, so we need to work together to figure out what we need to change – to get you the answers that you need.’ It’s very project specific. You can’t throw data at us, and we throw answers back.

And we’re always happy to talk with people if they have questions. People sometimes hesitate to contact us, because they don’t have a specific research project. But sometimes you don’t know what your research project is going to be, unless you know what services we can provide. It helps to call us before you even write a grant and to say, ‘Hey, what do you guys do?’

Use this form to request an NLP consultation and other informatics services at the Wright Center.

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VCU Wright Center joins national project to advance health research for all

The National Institutes of Health awarded the Wright Center a grant to support the center in joining a national health research project. The largest-of-its-kind database aims to enroll 1 million or more people from across the U.S. in order to advance health research for all.

“We’re proud to contribute to this historic project,” said F. Gerard Moeller, M.D., director of the C. Kenneth and Dianne Wright Center for Clinical and Translational Research and the VCU lead for All of Us. “As communities in Virginia work to combat the health disparities heightened by COVID-19, diverse representation in research has never felt more critical. All of Us will help find answers to some of our foundational health challenges.”

Read more at VCU Health.

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VCU researchers can now access national COVID-19 data

Virginia Commonwealth University researchers can now tap into a national resource to further their study of COVID-19.

The National COVID Cohort Collaborative, or N3C, led by the National Institutes of Health (NIH), securely collects and organizes clinical and diagnostic data from patients across the country to create a dataset broad enough to engage in meaningful research of the novel coronavirus.

VCU, led by the Wright Center, joined N3C this summer. As of last week, the collaborative contained de-identified data for more than 958,000 patients from across the country, meaning researchers have access to hundreds of millions of lab results, procedures and observations.

VCU researchers have two options for accessing the data:

Those wanting assistance can submit a request via the Wright Center’s Clinical Research Informatics support request form. This option gives researchers support with the Enclave system, as well as with navigating the N3C protocols.

Or, VCU researchers can register with N3C on their own and follow instructions on the website.

Investigators also have the option to join existing projects once they have signed up with N3C.

N3C key metrics dashboard, click for more
graphic credit: National Center for Advancing Translational Sciences