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.
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 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.
Lauren Harris, M.S., M.Ed., the Wright Center’s hub research capacity administrator, joined experts at VCU and VCU Health today to engage the community in Virginia Commonwealth University’s role as a clinical and translational science hub.
Harris offered participants an overview of the importance of clinical trials in human health research.
“They really show researchers what does and does not work in humans,” she said. “Trials help our loved ones live longer. They raise the standard of treatment.”
Harris promoted the Wright Center’s StudyFinder, which directs patients to clinical trials at VCU that they might qualify for.
Katie Schifano, M.S., outreach and engagement specialist at VCU’s Institute for Drug and Alcohol Studies, spoke about ResearchMatch, which connects people to trials across the country. She encouraged event participants to join the service, as well as to talk to their doctors about trials they might qualify for.
“Today’s treatments come from yesterday’s clinical trials,” said Schifano.
Finally, Mary Harmon, Ph.D., VCU Health’s director of clinical research, spoke to the rapid response to COVID-19 at VCU, which the Wright Center played a large role in. The pandemic, she said, was a chance to revamp many processes and procedures around clinical trials participation.
The goal she said, was that “every patient that walks in the door is offered the opportunity to be part of a clinical trial.” About 130 patients, she said, have enrolled in COVID-19 clinical trials at VCU Health Systems.
The event was part of the VCU Office of Continuing and Professional Education’s free Community Series. The virtual sessions take place on third Wednesdays between June and October this year.
Lauren Harris, Wright Center’s hub research capacity administrator, interviews Antonio Abbate, M.D., Ph.D., the medical director of the Clinical Research Unit and an associate director at the Wright Center, and Joan Greer, R.N., nurse manager at the Clinical Research Unit at VCU Health.
Abbate and Greer answer your questions about clinical trials participation and what it’s like running clinical trials during a pandemic – in honor of Clinical Trials Day on May 20.
Full transcription below:
Lauren Harris (00:06):
Good afternoon. Thank you all for taking the time out of your day to come and speak with me this morning about clinical trials. As we all know, and the world may also know, that international clinical trials day is coming up on May the 20th. This is truly a time for us to thank our clinical research, trial coordinators, our nurses, our doctors, anyone who helps in getting clinical trials off the ground. International Clinical Trials will be celebrated across the world, not only from VCU and VCU Health, but across the globe. We will all be telling you thank you for your hard work and your dedication that you all put into this. Surrounding this, this day allows us also to broadcast some of the clinical trials that we have going on here at VCU and VCU Health. So today with me, I have. Dr. Antonio Abbate who is the director of the clinical research unit here at VCU Health and Joan Greer, who is the nurse manager on the North 8 floor for the Clinical Research Unit. Thank you guys. Read More
Patient-centric care means patient-centric research. And that’s what the Wright Center and VCU Health do.
International Clinical Trials Day on May 20 celebrates the tireless work of the doctors, nurses and staff that make clinical trials happen. And it’s a chance to encourage patient participation in clinical trials.
On May 20, 1747, Scottish physician James Lind conducted the first clinical study of the treatment of scurvy on 12 sailors. Lind discovered that, of six therapies, oranges and lemons had the greatest positive effect on sailors’ health.
Today at VCU there are 492 active clinical trials with 5,347 participants enrolled, including several testing COVID-19 drugs like canakinumab and sarilumab.
Clinical trials advance research and medicine for all. And now, more than ever, we see the role that clinical trials can play in advancing public health. Trials at VCU like those of remdesivir have already contributed to what we know about COVID-19 and how we can treat it.
What can I do?
Members of the community and patients can:
talk to your doctor about clinical trials
search the Wright Center’s StudyFinder for current studies
sign up for ResearchMatch to get notifications about future studies
Three VCU faculty joined the leadership team of the Wright Center – official today. They bring a breadth of expertise and experience to the center’s mission of providing the infrastructure and resources that promote interdisciplinary human health research at VCU.
Robert Winn, M.D., who became director of VCU’s Massey Cancer Center in December, joins the Wright Center leadership team as an expert in lung cancer and community-based health care, including creating community-to-bench health models that combine discovery and implementation sciences into a single health delivery and research system. Winn will bring expertise to community collaboration and recruitment, translational workforce development in underrepresented communities, and faculty training techniques for improving diversity.
Winn comes from University of Illinois at Chicago where he has served as director of their cancer center and as associate vice chancellor of health affairs for community-based practice at the University of Illinois Hospital and Health Science System.
Robert L. Findling, M.D., MBA, joins Wright from the Department of Psychiatry, which he became the chair of last year. Findling is a renowned child psychiatrist and has over 20 years of experience conducting clinical research in child, adolescent and adult psychiatry fields – with expertise in pediatric psychopharmacology, acute efficacy studies, long-term treatment studies, characterization of young people with mental illness, and how to conduct successful clinical trials. He has served as principal investigator and as a coordinating principal investigator on multi-site clinical trials and longitudinal studies funded by the National Institute of Mental Health and the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
Vimal K. Mishra, M.D., an associate professor of medicine and health administration, joins the Wright Center as a researcher who has been heavily involved in the development of VCU’s telemedicine program. Misha will oversee informatics methods to enhance community engagement, such as Project ECHO (Extension for Community Health Outcomes), which builds mentoring based learning networks that connect subject-matter experts to practicing providers, clinicians and social health care professionals across Virginia. Currently, Project ECHO offers services in the areas of opioid addiction, sickle cell disease management and palliative care.
Imagine this: You’re walking down the street in the middle of the day when you encounter a stranger crouched and crying on the sidewalk. Is your instinct to comfort the person or to use their emotional vulnerability to hurt them?
“Most people can sense when others are in pain,” said David Chester, Ph.D., an assistant professor of psychology at Virginia Commonwealth University. “Whereas non-psychopathic people use that information to console the person, a psychopath might use it to hurt them.”
This conduct — something Chester refers to as “antisocial empathy” — is a trademark behavior of psychopaths. “Psychopaths use antisocial empathy all the time in the real world,” he said. “They possess the ability to feel empathy. They just use it to hurt, whereas everyone else uses it to help.”
“For this study, I’m shifting my focus from studying the act of violence to look at what is going on in the brains of psychopaths before they cause harm,” Chester said. “The idea is that once they’re in the act of hurting someone, you’re already too late. If we want to prevent violence, we need to understand what happens beforehand.”
For centuries, psychologists and neuroscientists maintained the conventional wisdom that psychopaths could not feel empathy. “For a really long time, the prevailing viewpoint was that psychopaths were born without empathic ability,” Chester said.
It wasn’t until advancements in brain imaging technology enabled researchers to investigate the physiological mechanisms that underlie human behavior that scientists began to question that commonly held belief.
“When we started getting better at brain imaging and being more subtle with our experimentation, we realized that psychopathic individuals can be empathetic,” Chester said, noting recent studies in which psychopaths were motivated to feel empathy for others.
In the studies, psychopathic individuals, while in MRI scanners, were shown videos of people experiencing pain. Without incentive, the signature biomarkers of empathy that can be read on a brain scan remained dim in the psychopaths’ brains, but when motivated to empathize, the psychopaths’ brains displayed the same levels of empathy as normal individuals.
“So it’s not that they can’t empathize, it’s just that they don’t,” Chester said. “It’s more a lack of motivation than a lack of ability.”
Building from the foundation that psychopaths can choose to feel empathy, Chester’s research team will be the first to investigate the inner workings of the brain when psychopaths are motivated to feel antisocial empathy. “We are trying to understand what is going on in the brain to cause psychopaths to choose not to use that function,” he said. He hopes the research will fill a gap in the scientific understanding of psychopathic behavior.
“If you give psychopaths a reason to feel empathy that fulfills their selfish goals — because that is all they really care about — then they can turn empathy on,” Chester said. “Just giving psychopaths something like money will incentivize them, but really what psychopaths want is to harm other people. That is what they are really motivated to do.”
Chester designed the Pilot Imaging Fund research study to do just that — motivating participants to empathize with others, with a reward of causing harm if they did.
For the pilot study that was conducted at the Wright Center’s Collaborative Advanced Research Imaging facility, the researchers recruited 46 adult male participants. Half of the men were at the low extreme of the psychopathy continuum and half at the high extreme, as determined by results from a questionnaire that identifies degrees of psychopathic traits.
While undergoing neuroimaging in the MRI, the research participants were shown scientifically validated images of faces of individuals who are simulating being hurt in various ways and to varying degrees — through shocking, burning and poking. The images were from a database of painful expressions collected by Peter Mende-Siedlecki, Ph.D., an assistant professor of psychological and brain sciences at the University of Delaware.
“He took pictures of people pretending to experience pain,” Chester said. “Sometimes it looks like it’s just a little bit of discomfort, all the way to excruciating pain.”
The VCU research participants thought they were participating in a study on how the brain makes decisions. They were told the images were of separate groups — VCU and University of Richmond students — to manufacture an “us versus them” mentality, and they were instructed to assess the degree of pain that they thought the people in the photos were experiencing. For example, by analyzing their facial expression, is it possible to discern if the University of Richmond student feels more pain from shock or from burning? At the end of the study, the participants were told to apply the most painful stimuli to the University of Richmond students and the least painful to the VCU students.
“The study participants are motivated to be accurate because they want to find the thing that hurts the University of Richmond students the most and the VCU students the least,” Chester said. “They are trying to be empathic in both conditions, but the difference is that in one condition, they are trying to be empathic so they can hurt others, and in the other condition they are trying to be empathic so they can help — antisocial versus prosocial empathy.”
An antidote to antisocial empathy
The researchers predict that psychopathic individuals will access the brain’s cognitive empathy network when doing so facilitates antisocial goals, such as harming a competitor, and that this neural recruitment will predict greater aggression toward their targets.
“If supported, this novel approach would readily translate into new motivation-focused interventions and would inform biological and psychological models of the monumentally costly phenomenon of psychopathic aggression,” said study co-principal investigator Nicholas Thomson, Ph.D., a forensic psychologist with VCU Health’s Injury and Violence Prevention Program and an assistant professor in the VCU School of Medicine Department of Surgery.
Chester and Thomson expect the findings to forge a potential new frontier for research on psychopathy, empathy and aggression.
“The great thing about pilot studies is that they fund projects that are groundbreaking,” Chester said. “We have predictions of how we think it is going to go, but it is so new and innovative that we really don’t know what is going to happen. The point of the pilot study is that by the time we’re done with this, we will have an initial idea of what the effects are and how strong they are.”
The researchers plan to apply for federal funding from the National Institutes of Health to launch a larger study after the pilot study concludes next year. “The idea is that we are going to take our findings and turn them right into a much larger grant application,” Chester said, adding that they hope to recruit men and women from diverse backgrounds to capture the nuanced, continuous nature of psychopathy.
Ultimately, the team hopes to discover an antisocial empathy circuit in the brain, which could be targeted with pharmacological therapies aimed at reversing antisocial empathy behavior. “We can identify people who are at risk for violence, but these risk assessments rarely include biomarkers,” Thomson said. He hopes the study reveals better targets for preventing violence among psychopathic individuals.
“The idea is that this research, hopefully in the future, will lead to the development of biologically informed treatment strategies that might be able to change activation in empathy circuits in the brain.”
VCU Wright Center for Clinical and Translational Research seeks talented individuals for the following positions to promote translational workforce development and experienced based training in clinical and translational research (CTR) and advance CTR methods and processes to speed translation, build collaborations and optimize resources within VCU and within the CTSA network.
The Educational Coordinator assists with workforce training initiatives organized by the Wright Center graduate educational programs and Translational Workforce Development training efforts. The Educational Coordinator provides student support, coordination of educational and training activities, and is committed to the goals of Wright Center. This position regularly interacts with the Graduate School, School of Medicine, and Student Accounts, on behalf of new and continuing students and trainees.
The position is responsible for overseeing all aspects of the planning, implementation and tracking of projects related to the Wright Center Hub Research Capacity Core, which seeks to provide innovative methods for recruitment of diverse research participants into VCU clinical trial, promote high quality in clinical and translational research (CTR) through scientific review and discovery, and develop, demonstrate and distribute innovative methods and approaches that improve efficiency in clinical and translational research (CTR). Incumbent will manage all aspects of the program including, but not limited to, collaborating with Hub leads and team members on project plans, VCU/VCUH interface for key initiatives; facilitating committee events, supporting, maintaining and tracking project plans and performance metrics, and communicating with institutional, regional and national colleagues of the NIH Clinical and Translations Science Award (CTSA) network.
This position acts as an education and compliance expert with regard to ClinicalTrials.gov, federal regulations, human subjects research requirements, and Virginia Commonwealth University policies and procedures for the protection of human subjects involved in research. Incumbent develops and coordinates procedures and programs to enhance principal investigator (PI) understanding and compliance as it relates to human subjects research and the related policies and procedures impacting VCU, such as: Create and oversee an institution-wide program for planning, delivery, monitoring, and evaluation of compliance with ClinicalTrials.gov and related policies and procedures impacting VCU; Develop, implement and evaluate education and outreach materials, tools and programs for principal investigators (PI) and study teams in consultation with the Office of Research and external stakeholders that improve quality and consistency in clinical and translational research (CTR) at VCU; Advise and guide translational workforce development by identifying knowledge gaps and helps to address those needs with the development of additional education and outreach materials, tools and programs as deemed essential.
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.
The NIH announces numerous policy changes to improve the stewardship of clinical trials.
Please read the full announcement here:
Message to NIH grant applicants/awardees, contractors, researchers and research administrators:
If you are conducting NIH-funded research that involves human subjects, or are considering applying to NIH for support of such research, we want to call your attention to important changes that may affect how you:
select the right NIH funding opportunity announcement
write the research strategy and human subjects sections of your application
comply with appropriate policies and regulations
First, familiarize yourself with the new PHS Human Subject and Clinical Trial Information form.
For application due dates of January 25, 2018, and beyond, you will be required to use an updated application forms package (FORMS-E), which includes the new human subject and clinical trial form. This form requests human subject and clinical trials information at the study level using discrete form fields, which is a change from current practice. Contract proposals will also require this information. Learn about the new form here.
Second, take a moment to answer these four questions about your current or proposed research:
1) Does the study involve human participants?
2) Are the participants prospectively assigned to an intervention?
3) Is the study designed to evaluate the effect of the intervention on the participants?
4) Is the effect that will be evaluated a health-related biomedical or behavioral outcome?
If the answer to all four questions is yes, then your proposed research meets the NIH definition of a clinical trial. Clarified and broadened in 2014, the definition encompasses a wide range of trial types: mechanistic, exploratory/developmental, pilot/feasibility, behavioral, and more. NIH expanded the clinical trial definition in response to widespread calls from diverse stakeholders for improved reporting of research milestones and outcomes, and for assuring maximal transparency.
Need help determining whether your study would be considered by NIH to be a clinical trial? See our webpage on the definition that includes case studies, FAQs and other resources that can help. Still unsure? Contact your NIH program official or the scientific point of contact listed on the funding opportunity announcement to which you are applying.
Third, familiarize yourself with NIH policy changes related to enhancing stewardship of clinical trials.
NIH made a number of policy changes to improve the stewardship of clinical trials across the life cycle of the trial. We encourage you to familiarize yourself with all that is changing, including:
the requirement to apply to an FOA that specifically allows for the submission of clinical trial applications for due dates beginning January 25, 2018.
Good Clinical Practice training expectations for NIH staff, grantees, and contractors that went into effect January 2017.
updated peer review criteria that will be included in FOAs for clinical trial applications and solicitations for due dates on/after January 25, 2018.
new Human Subject Information form requirements for clinical trials that will be included in updated application forms (FORMS-E) for due dates on/after January 25, 2018, and contract solicitations published as of January 25, 2018.
use of a single IRB for non-exempt, multi-site clinical trials for application due dates on/after January 25, 2018.
expanded ClinicalTrials.gov registration and reporting to include all NIH supported clinical trials.
Improving the design, efficiency, and transparency of clinical trials is important because it:
respects our ethical obligation to participants to maximize the use of the knowledge from the trials in which they participate
facilitates design of clinical trials while reducing unnecessary duplication
promotes broad, timely, and responsible dissemination of research information and results
fosters responsible stewardship of the public’s investment in biomedical research