Our latest TRIbune newsletter highlights a milestone for TRI’s Implementation Science Scholars Program. The program, led by Geoffrey Curran, Ph.D., graduated its first cohort of five scholars. All impressed the program’s external evaluator and program leaders with strong project reports, which we have summarized.
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.
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).
The KL2 program is supported by the Clinical and Translational Science Award (CTSA) Program of the NIH National Center for Advancing Translational Sciences.
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 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.
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, email@example.com
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 (firstname.lastname@example.org) or Paul Duguid (email@example.com) 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.
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).
“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.
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
- 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
Chris Long, Ph.D., presented “Ethical Considerations Regarding Returning Results to Research Participants.”
Joseph Sanford, M.D., and Kevin Sexton, M.D., presented “Digital Health Resources in Remote Research.”
View many other video presentations in TRI’s Video/Knowledge Library.
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.
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