David Robinson

The TRIbune Is Here!

In this issue of The TRIbune, we highlight the insightful and fascinating presentations of our two national keynote speakers during TRI’s annual Research Regulatory Conference – Virtual Research in a Complicated World.

Both Chris Lindsell, Ph.D., from Vanderbilt, and Erin Rothwell, Ph.D., from the University of Utah, spoke on the research changes and challenges that resulted from COVID-19. You can view their presentations and other great presentations from the conference on the TRI website/YouTube.

In this issue we also include our Study of the Month, featuring Sisira Yadala, M.D., and updates to ARresearch that will benefit UAMS-affiliated researchers.

We are also happy to announce the addition of Carolyn Greene, Ph.D., to the TRI team. Greene became associate director of Programmatic and Strategic Planning on Dec. 1. Read The TRIbune.

TRI Seeking Letters of Intent from Prospective 2022 KL2 Award Applicants

The UAMS Translational Research Institute (TRI) is pleased to invite Letters of Intent (LOI) for the 2022 KL2 Mentored Research Career Development Scholar Awards.

KL2 Scholar Awards are part of the TRI Career Development Scholars Program, which provides support for early-career UAMS faculty with a professional degree (M.D., Ph.D., Pharm.D., D.N.P., Dr.PH., D.O., etc.) who are committed to an academic career in multidisciplinary clinical or translational research.

Successful applicants will begin the two-year program July 1, 2022. The KL2 program combines an innovative educational program with mentored clinical/translational science research. KL2 Scholars receive:

Salary support/stipend of up to $95,000 (including fringe) per year.
Up to $25,000 of non-salary support per year, which can be used for research, tuition, travel expenses, educational materials and other costs related to the scholar’s research.

The deadline for submitting LOIs is Jan. 24, 2022, 5 p.m. (CT).

See attached LOI Cover Page PDF.

The KL2 program is supported by the Clinical and Translational Science Award (CTSA) Program of the NIH National Center for Advancing Translational Sciences.

TRI Study of the Month

*Sisira Yadala, M.D., an epileptologist, is assisted on the study by TRI’s Renee Shaide, M.N.Sc., APRN, FNP-BC, clinical research coordinator.*

Principal Investigator: Sisira Yadala, M.D., Director, Division of Epilepsy; Director, Clinical Neurophysiology Lab, Assistant Professor, Department of Neurology; College of Medicine.

Summary: A phase 3 clinical trial evaluating the efficacy and safety of intravenous Ganaxolone as a potential treatment for refractory status epilepticus, uncontrolled seizures that do not respond to typical first and second line seizure medications.

Significance: Status epilepticus is a serious condition that requires immediate intervention to stop the seizures and prevent permanent brain damage.

TRI Services: Budget development, Medicare coverage analysis, regulatory and research nurse coordinator services.

Sponsor: Marinus Pharmaceuticals Inc.

TRI Announces 2022 Research Leadership Training Program for Community-Based Organizations

TRI is inviting applications from community-based organizations to participate in a six-month research leadership training program and receive up to $2,500 in seed funding to implement a real-world project.

Led by the TRI Community Engagement team, the 2022 Community Partners Educated as Arkansas Research Leaders (CPEARL) Program will include up to six teams. Each team will also have a UAMS researcher and community mentor assigned to mentor them throughout the year.

An information session will be held Jan. 19, noon – 1 p.m.

View flyer for additional details.

Visit the CPEARL webpage.

Please share with your community partners and others. This is a great opportunity for community-based organizations to improve their partnership readiness.

Contact: Rachel Hale, rbhale@uams.edu

TRI Offers New $75,000 Team Science Champion Award

TRI is now seeking applicants for a new Team Science Champion Award that will support early stage, cross-disciplinary collaborations.

One-year grants of up to $75,000 will be awarded to up to two cross-disciplinary teams. The funded research will involve telemedicine, digital health or other innovative technologies, and it will address rural health. Proposed projects will involve a collaboration with a rural provider, such as the UAMS Rural Research Network or similar located outside of the UAMS Little Rock campus catchment area.

TRI is particularly interested in projects that forge new collaborations across multiple disciplines that directly support its mission to develop new knowledge and novel approaches that will measurably address the complex health challenges of Arkansas’ rural and underrepresented populations.

Team Science Champion Award information sessions will be offered on 12/16/21, 01/06/22, and 01/27/22. Please email Adam Kleinerman (akleinerman@uams.edu) or Paul Duguid (pduguid@uams.edu) if you would like to attend one of these sessions.

Letters of Intent are due Feb. 7, 2022. Submit your letter here.

All applications must be received no later than March 14, 2022.

Read the Request for Applications for details.

TRI Aids Testing of ‘Big Advance’ in Spinal Cord Stimulation; First Arkansas Participant Now Pain Free

Cornelia Ann Smith of Calico Rock, Ark., here with two of her grandchildren, is pain free thanks to her participation in a UAMS study of an advance in spinal cord stimulation devices.

Cornelia Ann Smith’s severe chronic back pain disappeared almost as soon as the experimental spinal cord stimulator was activated in a procedure at the University of Arkansas for Medical Sciences (UAMS).

Watch a short video about Cornelia Ann Smith’s experience in the device study led by UAMS neurosurgeon Erika Petersen, M.D. (left). (Image credit: Robinson, David S)

“I realized the device was helping me immediately,” the Calico Rock, Ark., resident said. Then, back home, it really began to sink in.

“I was sitting on the couch, and I thought, ‘This is amazing.’”

For six years prior to the implant, she struggled to take care of her home and her husband, who has Parkinson’s disease, and she could not enjoy her many hobbies.

“It felt like a bonfire in my back, and there was nothing anyone could do about it,” she said.

When she learned that UAMS was testing the spinal cord stimulator in a clinical trial, she contacted UAMS and was referred to neurosurgeon Erika Petersen, M.D., who is leading the device study.

“We talked about what her goals should be,” said Petersen, a national leader in spinal cord stimulation for chronic pain. “She wanted to be able to garden and go fishing and play with her grandchildren.”

Smith had many questions about the surgical implant procedure.

“After speaking with Dr. Petersen and hearing why she was confident in the device and her confidence in the procedure, I was all for it — 100%,” she said.

Prior generations of spinal cord stimulation devices include a small remote control that the patient uses to adjust the level of electronic stimulation if their pain spikes.

In January 2021, Smith became the first Arkansan to benefit from the latest technology. The so-called closed-loop experimental device does not require manual adjustment of the electronic stimulation; the system monitors the patient’s pain and adjusts the stimulation as needed.

The device was developed by Saluda Medical of Artarmon, New South Wales, Australia, and is being tested in the ECAP (evoked compound action potential) study.

“I would say this is a pretty big advance,” said Petersen, a professor in the College of Medicine Department of Neurosurgery. “This is the difference between constantly having to maintain the device and interact with it to being able to forget it and let it be in the background. That means people are able to stop thinking about where they are with their chronic pain control and just think about what they want to do during their day.”

Petersen said other study participants have reported pain decreases of more than half and up to 100%, like Smith.

“We are seeing some great results so far, and it’s significant that their pain relief is being sustained over time,” Petersen said.

UAMS is one of 13 research sites in the United States participating in the study.

“I’ve been really excited to be in the field of neuromodulation for the past decade because we have had an explosion in these sorts of technologies starting from about 2015, with more and more innovations coming,” Petersen said. “With every innovation we have an opportunity to help more people who have chronic nerve damage related problems.”

UAMS is still recruiting participants for the study. Those interested in participating must be referred through the UAMS Pain Clinic, which assesses patients to determine if they are eligible.

The study is supported by the UAMS Translational Research Institute, where research nurse coordinator Lisa Richardson, RN, works closely with the study participants.

“Being a part of this research study has been a pleasant experience,” Smith said. “It’s been eye-opening. Lisa checks on me often and she gave me her phone number so I can call her any time I need to.”

In a follow-up visit to UAMS on Oct. 28, 2021, Smith reported that she remains pain free.

“It has changed my life,” she said.

Watch a video here about Smith’s experience in the clinical trial.

Video Recordings Now Available: TRI Research Regulatory Conference – Virtual Research in a Complicated World

If you missed TRI’s annual Research Regulatory Conference – Virtual Research in a Complicated World, video recordings are now available. Below are YouTube links for each part of the agenda.

Keynote speaker Erin Rothwell, Ph.D., from the University of Utah, presented, “Promoting Informed Decision Making for Consent in Virtual Research,” to kick off the conference. https://youtu.be/0hGEd1QM-2I

Keynote speaker Chris Lindsell, Ph.D., from Vanderbilt University, “ACTIV-6, TREAT-NOW and Other Stories: Lessons Learned from Running Decentralized Platform Trials during a Pandemic.” https://youtu.be/uOJZKHIppC8

Q&A Panel: Common Compliance Issues with Remote Research

Moderator: Edith Paal, M.S.Journ., MPH, director, UAMS Institutional Review Board

Panelists:

Aline Andrews, Ph.D., RD, co-interim director, Arkansas Children’s Nutrition Center; professor, Department of Pediatrics, College of Medicine, UAMS
Jamie Baldner, B.S., CCDM, research informatics director, Department of Biomedical Informatics, College of Medicine, UAMS
Hari Eswaran, Ph.D., professor and director of Research, Department of Obstetrics and Gynecology, College of Medicine, and Institute for Digital Health and Innovation, UAMS
Darri Scalzo, research compliance officer, Office of Research Compliance, UAMS
https://youtu.be/sztEOYtg-W8

Chris Long, Ph.D., presented “Ethical Considerations Regarding Returning Results to Research Participants.”
https://youtu.be/PbRiPKlnrrU

Joseph Sanford, M.D., and Kevin Sexton, M.D., presented “Digital Health Resources in Remote Research.”
https://youtu.be/mrDp99bQwjQ

View many other video presentations in TRI’s Video/Knowledge Library.

The TRIbune Is Here!

The October TRIbune features the new Clinical Informatics Fellowship Program. The fellows are (l-r) junior fellow Salem AlGhamdi, M.B.B.S. (emergency medicine); senior Daniel Liu, M.D. (pediatrics); senior Lori Wong, M.D. (preventive medicine); and transfer senior Jacob Wooldridge, M.D. (pathology). Pictured separately is junior fellow Obeid Shafi, M.D. (pediatrics).

In this month’s TRIbune, we highlight the exciting addition of the Clinical Informatics Fellowship Program, a TRI-supported collaboration between UAMS and Arkansas Children’s. This important and unique program is among the first nationally accredited in the U.S., and is attracting talented doctors with informatics expertise.

This issue also includes important implementation science news, an announcement of our Team Science Voucher Awardees, and our TRI Study of the Month features Sumant Inamdar, M.D.

Read The TRIbune.

TRI Study of the Month

Sumant Inamdar, M.D., (right) with Danielle Evans, Ph.D., TRI research program manager.

UAMS Site Principal Investigator: Sumant Inamdar, M.D., Assistant Professor, Division of Gastroenterology and Hepatology, Department of Internal Medicine, UAMS College of Medicine.

Summary: The SpHincterotomy for Acute Recurrent Pancreatitis (SHARP Trial) is testing the effectiveness of Endscopic Retrograde CholangioPancreatography with sphincterotomy, a common procedure for the condition. it is an NCATS Trial Innovation Network (TIN) facilitated study.

Significance: Pancreatitis can cause severe pain. A sphincterotomy opens a blocked duct in the pancreas to allow fluids to drain, which researchers hypothesize provides long-term relief to the acute pain associated with the condition.

TRI Services: Budget development, Medicare coverage analysis, regulatory and research nurse coordinator services.

Sponsor: NIH National Institute of Diabetes and Digestive and Kidney Diseases

UAMS Part of CTSA Research Network Supporting Translational Science Across the Criminal Justice Continuum

Researchers at the University of Arkansas for Medical Sciences (UAMS), the University of Kansas Medical Center (KUMC), and the University of Kentucky (UK) are teaming up to develop a Clinical and Translational Science Award (CTSA) research network to support translational science across the criminal justice continuum.

Criminal justice settings provide an opportunity to engage difficult-to-reach populations who have significant underlying health conditions, including a high burden of chronic and infectious diseases and behavioral health disorders. However, few public health interventions are specifically tailored to be delivered within criminal justice settings or with individuals involved in the criminal justice system, and only a fraction of NIH grants focus on criminal justice related health research.

“I’m very excited that UAMS will be participating in this unique collaboration to address the pressing public health challenges among people involved in the criminal justice system,” said Nick Zaller, PhD, Professor of Health Behavior and Health Education at UAMS. “By establishing a network of CTSA institutions to support this work, we will be able to develop a national model for research to improve the lives of those most impacted by incarceration in the United States.”

This project will leverage the existing clinical and translational research infrastructure at the three partnering institutions through their respective Clinical and Translation Science Award (CTSA)-funded units. The researchers expect the proposed network to have a profound impact on the future direction of research involving this underserved population.

“I am thrilled that this project brings together new friends and collaborators to really make a mark in the field of criminal legal system research and public health,” said Megha Ramaswamy, PhD, MPH, Professor of Population Health at KUMC. “We hope to work on research that benefits the 13 million Americans who pass through jails every year. Doing so through the CTSA infrastructure should only boost our reach in this effort.”

The network will also be used to develop new investigators and support established ones in the development and implementation of research on the health of criminal justice-involved individuals across CTSA institutions through facilitation of multidisciplinary research collaborations.

“I am really excited to be a part of this project because justice-involved individuals are often among the highest risk for health and behavioral health issues, yet evidence-based interventions often neglect this population” said Michele Staton, PhD, Professor in the Department of Behavioral Science at the University of Kentucky. “I also love the idea of being a part of the development of a CTSA research network supporting both translational science across the criminal justice continuum and resources for other investigators to initiate or advance their own criminal justice research.”

The project is being funded by the Consortium of Rural States (CORES) Research Collaborative Inter-Institutional Pilot Project Award program.

“There are a number of unique challenges to conducting research with justice-involved individuals and/or working in justice settings,” Staton said. “This grant provides a tremendous opportunity to build capacity for translational research, as well as expand critical health and behavioral health interventions.”

The Inter-Institutional Pilot Project Awards promote collaboration across the CTSA consortium by funding innovative, translational research projects that involve three or more of the institutions that make up the CORES Research Collaborative: University of New Mexico Health Sciences Center; University of Kansas Medical Center; University of Kentucky; University of Arkansas for Medical Sciences; University of Iowa; and the University of Utah Health. The CORES program is funded as part of the CTSA through the National Center for Advancing Translational Sciences of the National Institutes of Health.

“Individuals in the criminal justice system comprise a seriously underappreciated population that has significant and unique medical challenges. Moreover, these issues are understudied, in large part due to the difficulty in accessing potential participants and from the historical abuse of prisoners in research,” said William M. Brooks, Ph.D., Associate Director of Frontiers and Director of the Frontiers Pilot Awards Program. “This CORES-funded grant will help build vital infrastructure to carry out research to better understand the problems, test solutions, and ideally lead to reduced social and financial costs to the community at large. Involving three states, Arkansas, Kansas and Kentucky, will better represent the challenges of incarcerated populations and result in more generalizable outcomes.”

Additionally, the Journal of Clinical and Translational Science (JCTS), an open access journal whose mission is to provide a forum for disseminating advances in clinical and translational science, has offered the study team a special issue, focusing on the theme “Health and Social Drivers in the Criminal Justice System.” Submissions are due in March 2022.

“We are really excited the Journal of Clinical and Translational Science will dedicate this special issue to our project and research in the criminal justice system,” Ramaswamy said. “Disseminating research results is key to the success and sustainability of any project, but especially one like this one as we build this nationwide network.”