Research Newsletter - January 2025
Colleagues,
As we enter the new year, I would like to highlight the results of our Research Acceleration Program and the date and venue for our Annual Research Day.
This year, we received over 22 submissions for RAP funding across the three tier levels. I am especially encouraged by the 13 applications submitted at the Tier II level. Tier II grants, which provide funding of up to $15,000, support nascent projects requiring less funding than Tier I grants to get started. While we are unable to fund every promising proposal, allocating funding to a broader group of researchers—including those new to the process—strengthens our research enterprise and fosters innovation across the organization. I encourage applicants who were not funded this cycle to consider the reviewers’ comments and suggestions as they prepare to resubmit in future cycles.
After many years of holding Research Day on the 6th floor of Roanoke Memorial Hospital, the growth of our research enterprise has necessitated the need to find a more suitable location. I am happy to report that Research Day will be held on Monday, April 14th at Riverside 4, G-102 A & G-102 B. Look for information and the registration link in mid-February.
Lastly, as mentioned in our last newsletter, Carilion Clinic is embarking on an Opt-out Research Institution. This initiative has been developed with input from several key functional areas, including the Institutional Review Board (IRB), Compliance, Health Analytics, Legal, and Human Resources. As we work through this process over the next 18 months, we would like to ask for your opinions and comments by completing the brief survey in this newsletter.
In closing stay warm and may your “favorite” team advance to the Super Bowl.
Regards,
Francis X. Farrell, PhD
Senior Director, Research and Development
Research Acceleration Program 2025 Recipients
Carilion Clinic’s Research Acceleration Program (RAP) provides funding to Carilion employees interested in conducting clinical, biomedical, or behavioral research. The program prioritizes projects that advance Carilion’s care objectives, foster educational and research excellence, and strengthen interdisciplinary collaborations within Carilion and with regional research institutions.
While all innovative and rigorous research proposals were considered, applicants were encouraged to align their research with the Vision 2025 Research and Innovation Goals, which include:
- Expanding, designing, and investing in the care delivery of the future.
- Growing and investing in clinical platforms to enable cutting-edge treatment capabilities.
- Deepening academic partnerships with:
- Virginia Tech
- Fralin Biomedical Research Institute at VTC
- Radford University Carilion
This year’s RAP grantees are advancing evidence-based research across nine clinical and professional domains. Congratulations to the following researchers who received RAP funding for their impactful studies:
Tier I: Awarded up to $40,000
- Neurosurgery
- Kristine Ravina, M.D. - Immune cell control of vasospasm following aneurysmal subarachnoid hemorrhage
- Medicine, Internal Medicine
- Robert Carpenter, M.D. - A Double-Blind, Randomized, Pilot Study to Investigate the Efficacy of a Topical Palmitated Formulation of Capsaicin (Capsadyn®) In the Treatment of Diabetic Neuropathic Foot Pain
- Orthopaedic Surgery:
- W. Garret Burks, Ph.D. - Development of a Patient- and Occupational-Specific Prognostic Model to Predict Return-to-Work Behaviors Following Orthopaedic Surgery - a Prospective Investigation
- Jonathan Carmouche, M.D. - Does Room Temperature Matter? A Quantitative Analysis of the Influence of the Operating Room Environment on Patient Safety and Outcomes
Tier II: Awarded up to $15,000
- Emergency Medicine
- Rachelle Dykstra, M.D. - Impact of Peer Norming on Provider Firearm Access Screening of ED Patients Presenting for Mental Health Concern
- Research & Development
- Mark Frazier, Ph.D. - Quantification of antimicrobial resistance genes in bacteriophages and isolation of bacteriophages of pathogenic bacteria from local water sources
- Radiology
- Biraj Patel, M.D. - Interrogating Human Serum Expression of Vascular Biomarkers for Pial Collateral Vessel Function Following Acute Ischemic Stroke
- Medicine, Infectious Disease
- Maimuna Jatta, Ms.N. - Investigating the impact of use of alcohol-based hand rub (ABHR) on the bacterial bioburden on gloves used in direct patient care
- Elizabeth Nowak, M.D. - Optimization of Acinetobacter Radioresistens Biofilm for Radiation Shielding
Tier III: Awarded up to $2,500
- Medicine, Pulmonary and Critical Care Medicine
- Sameh Aziz, M.D. - Enhancing Early Detection and Management of Non-Convulsive Status Epilepticus by Implementing Ceribell rapid EEG for Improved Patient Care
- Medicine, Neuroscience
- Thomas Kodankandath - Enhancing Patient Care through Photographic Documentation of the Fundus in Neurology
For more information about RAP or this year’s grantees, please contact:
- Francis Farrell – Research & Development, at fxfarrell@carilionclinic.org
- Melissa Mercure – Research & Development, at mzmercure@carilionclinic.org
Opt-out Research: Physician Survey
Carilion Clinicis preparing for further advancement of the research enterprise. Current practice at Carilion requires that the treating providers be the first patient contact about potential research opportunities. We are changing practice so that patients can be contacted by researchers who are not their providers. The first step is a new process to allow patients the choice to opt-out of being contacted by researchers who are not their providers. Patients will be notified by various methods, and their responses will be gathered. More information will be provided over the next several months as this significant research recruitment practice change is being developed. Please note that the current recruitment process remains unchanged, and the IRB approved plan must be followed. We would like to obtain your opinion on this process by completing the survey link below:
https://redcapweb.carilionclinic.org/redcap/surveys/?s=8LLDCLW3DE93WETM
Advarra eReg: New Electronic Regulatory System
With the start of the new year, the R&D department is implementing Advarra eReg, a new electronic regulatory management system, to support sponsored clinical trials. This transition marks a significant step forward, moving from paper-based documentation to a centralized, cloud-based platform. The implementation of Advarra eReg will bring numerous benefits, including enhanced access and efficiency, electronic signature capabilities, centralized credential and training management, and improved external monitoring review processes.
Sponsored clinical trials currently undergoing start-up, as well as future trials, will utilize this system for regulatory management with the support of our Regulatory Affairs team. Please expect direct communication from our department regarding training completion and system access for your upcoming trials.
Additionally, active trials will be evaluated for integration into Advarra eReg based on their anticipated closure dates. Further details about this process will be shared in the coming months.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Update
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH's mission has been to achieve greater harmonisation worldwide to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner. Harmonisation is achieved through the development of ICH Guidelines via a process of scientific consensus with regulatory and industry experts working side-by-side. Key to the success of this process is the commitment of the ICH regulators to implement the final Guidelines. On January 6, 2025, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) issued its final version of the “Guideline for Good Clinical Practice E6(R3)” to update its 2016 E6(R2) GCP guideline. E6(R3) is now pending adoption by the ICH member nations including the Unites States/ FDA.
More information on these guidelines can be found at the CITI program website: https://about.citiprogram.org/blog/ich-releases-final-version-of-e6r3-good-clinical-practice-guideline/
R&D Employee Career Advancement
Becca Butterworth, B.S., Clinical Research Coordinator II – Cardiovascular Institute
Becca recently advanced from CRC I to CRC II. She supports a variety of drug and device studies in the Departments of Cardiology and Cardiothoracic Surgery. Before joining the CVI research team, Becca was a Clinical Research Assistant in the Department of Mental Health. She also brings valuable knowledge to our team from her experience as a Clinical Associate at Carilion. Congratulations on your advancement, Becca!
Carilion Clinic TriNetX Virtual Training Schedule
Carilion offers instructor-led, focused training for an in-depth, step-by-step learning experience building patient cohorts and delving into Analytics. The facilitator will be Dee Myers. Please get in touch with HART@carilionclinic.org with the subject of 'TriNetX Training' for training outside of the scheduled sessions. If you haven’t taken a class or need a refresher, this is your opportunity to do so! Let Dee Myers know which date you prefer and she will send a meeting invitation.
- Jan 30, 1:30 – 3 p.m.
- Feb 13, 10:30 a.m. – noon
- Feb 27, 1:30 – 3 p.m.
- Mar 11, 10:30 a.m. – noon
- Mar 26, 1:30 – 3 p.m.
TriNetX User Agreement: https://redcap.link/v5pw9j7j
Current R&D Job Openings
The Clinical Research Coordinator will support a grant funded project at Carilion Clinic in the assigned department. Basic responsibilities include supporting research investigators/physicians with guidance on research policies and processes, enabling successful collaborations with research sponsors, monitoring and tracking study progress, study design assistance, regulatory submission and maintenance, research subject visit management, obtaining tissue specimens for processing, and any other research-related duties, as necessary.
Clinical Research Coordinator - Cardiology
Clinical Research Coordinator - Cardiothoracic Surgery
Clinical Research Assistant assists with administrative activities associated with the conduct of research studies including industry sponsored, investigator initiated, grant funded, or internally funded studies while maintaining compliance with guidelines set by governing agencies and institutional policy. This position will be assigned to support minimal risk or non-interventional studies, unless assigned to serve in a support function for greater than minimal risk studies that also include a Clinical Research Coordinator or Clinical Research Nurse.
Clinical Research Assistant - Aortic Center
Clinical Research Assistant - Emergency Medicine
My Project Path:
Resources and Processes for Research, Grants, and QA/QI
Want to do a project, but don’t know where to start? Or, experienced but want to see what new resources are available?
To learn about Carilion’s resources and processes for Research, Grants and QA/QI, visit https://redcap.link/MyProjectPath. This tool provides easy navigation to topics of interest, including links to the Research and Development Application and the IRB PRIS3M application.
iTHRIV Learning Shorts
iTHRIV periodically creates short educational videos, named "Learning Shorts". Learning Shorts are brief, digestible online educational offerings organized around a specific topic. iTHRIV hopes that these videos will help educate, dispel misinformation, and create a basis for conversation between the community and health researchers. To learn more visit: https://www.ithriv.org/short-educational-videos
iTHRIV Updates:
Upcoming Workshops and general information: https://portal.ithriv.org/#/home
Newsletter link: https://www.ithriv.org/april-2023-newsletter
* Carilion Clinic Research and Development is honored to partner with a growing list of prestigious national and statewide research centers and healthcare organizations. Find out more about our collaborative research initiatives; explore our unique public-private partnerships with the Virginia Tech Carilion (VTC) School of Medicine, Virginia Tech, Fralin Biomedical Research Institute, Radford University Carilion, and others. Connect with our team to discuss opportunities to collaborate with our experts or become a participant.