Colleagues,

Just a quick reminder that I’ll be hosting office hours every Tuesday from 12:00–3:00 PM. Feel free to drop by during that time if you have questions, need support on anything you're working on, or just want to chat through ideas. No need to book ahead — I'm here to help! Looking forward to connecting with you.

Best,

Michael Wilson, MD, PhD

Surgical Research Career Advancements

• Katie Bower, MD MSc; Vice Chair of Surgical Research
• Sydney Webb, MPH; Director of Surgical Research
• Miebaka Roberts, MBBS MPH; Clinical Research Coordinator

Regulatory Workflow
 

Research Regulatory Affairs Specialists play a critical role in ensuring that clinical trials comply with all applicable regulations, guidelines, and institutional policies. The Research and Development Department at Carilion Clinic currently houses several regulatory affairs specialists to support the regulatory and compliance aspects of our sponsored clinical trials. They serve as a liaison between investigators, sponsors, local and central Institutional Review Boards (IRBs), and internal and external regulatory agencies to ensure that all research activities are conducted ethically and in accordance with federal, state, and institutional regulations.   Regulatory Affairs Specialists are available to help you with your regulatory needs from study start-up to closeout and beyond. For more information on the regulatory workflow of a clinical trial please click here

Updated Education for FDA Guidance Publication of ICH E6(R3) Good Clinical Practice (GCP)

In January 2025, the International Council for Harmonisation (ICH) published an updated guideline titled Guideline for Good Clinical Practice E6(R3) intended to outline flexible and modern good clinical practices for conducting clinical trials. On September 9, 2025, the Food and Drug Administration (FDA) published its final guidance for E6(R3) Good Clinical Practice as a guidance to industry. While not legally binding, adherence to these recommendations is expected of investigators conducting clinical trials to meet quality of safety standards, safeguard the rights of human participants, and ensure the reliability of trial results.   

Beginning October 15, 2025, completion of the Carilion Clinic CITI Good Clinical Practice basic or refresher course will include the recent E6(R3) changes.  Completion of this course is an institutional requirement for all key research personnel assigned to a clinical trial that involves the use of an FDA regulated product and/or receiving federal funding.

If your CITI certification for this course is not due to expire prior to December 31, 2025, you may receive training for the E6(R3) guidance via REDCap. An acknowledgement of your training, along with your signature can be emailed to you to be shared with your clinical trial sponsors to confirm your acknowledgement of this update in lieu of additional sponsor GCP training or retaking the entire CITI GCP course prior to expiration.

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.

• Nov 6, 1:30 – 3pm
• Dec 17, 10:30am - noon

 https://redcap.link/v5pw9j7j to sign up for TriNetX digitally.

For more information visit:https://redcapweb.carilionclinic.org/redcap/surveys/?s=dcUCIpMAzk8BqKH2

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CORCINCH-HF (Cardiology): The CORCINCH-HF trial explores the use of the AccuCinch Ventricular Restoration System for patients who have

1. Heart failure,

2. Left ventricular enlargement, and

3. Persistent symptoms despite guideline-directed medical therapy.

More information about CORCINCH-HF, including eligibility criteria, is available here.

RAMP (Rheumatology in collaboration with the Department of Psychiatry & Behavioral Medicine): Despite control of their rheumatoid arthritis (RA), many patients continue to experience joint and extra-articular pain. In addition, many patients with RA also experience depression and/or anxiety. The RAMP study assesses whether the treatment of mood disorders affects pain levels in patients with well-controlled RA. Please click here to learn more about RAMP.

Abhishek Reddy, MD, a child and adolescent psychiatrist in our Department of Psychiatry and Behavioral Medicine, conducted a study in adolescents aimed at evaluating the timing of intentional overdose attempts and whether they occurred in the context of recent screen use, as well as whether over-the-counter or prescription medications were used.  

VTCOM LinkedIn Post:  A heartbreaking and important story by Meg Oliver on CBS news last night highlighting a study by Abhishek Reddy and Timothy Ferrebee. The study examined data of children ages 12 to 17 who had been admitted to a hospital after attempting suicide by intentionally overdosing. It found that about two-thirds of those overdosed after 8 p.m., and approximately three out of four were on screens right before. "It is very distracting and disturbs your sleep," Dr. Abhishek Reddy, an associate professor at the Virginia Tech Carilion School of Medicine and psychiatrist at Carilion Clinic conducted the research, said of screen use before bed."If you or someone you know is struggling, call or text 988 to reach the Suicide and Crisis Lifeline — help is available 24/7.  Further study mentions: 

Mother of 10-year-old girl who died by suicide turns grief into a warning for other parents over nighttime cell phone use - CBS News

Mom Warns About Nighttime Phone Use After Daughter Dies by Suicide

Teen Suicide Attempts Linked to Late Night Screen Use and Medication Access | Psychiatric Times

https://www.psychiatrictimes.com/view/teen-suicide-attempts-linked-to-late-night-screen-use-and-medication-access

Could GLP-1s help people drink less alcohol? Anita Kablinger, MD, CPI, collaborated with our partners at Virginia Tech and Fralin Biomedical Institute to explore this question in a study led by Alex DiFeliceantonio, PhD.

Dr. Kablinger played a key clinical role, drawing on her experience treating substance use disorders to guide the study’s design and interpretation. She was also present to monitor participants’ reaction to the alcohol cocktail they consumed as part of the research, making sure they were safe to go on their way after their participation was over.

“Dr. Anita Kablinger has been deeply involved in this project from start to finish,” said Dr. DiFeliceantonio. Check out the LinkedIn article to learn more. 

Research and scholarly activity are vital components of a resident physician’s training. However, it can be tough to squeeze in between seemingly endless shifts, coursework, studying, and rotations in other departments. Dr. Andrea Klein, a third-year resident in the Department of Emergency Medicine (EM), makes striking that balance look effortless. Dr. Klein always possessed a passion for research and medicine that has translated into an already impressive list of publications and presentations, the majority focusing on advancing care in the neurosciences.

As a resident, Dr. Klein has sought to help her peers ‘genuinely enjoy’ engaging in research the way she does. She is the education chair for the department of emergency medicine, was the co-chair of her residency’s journal club for the 2024-2025 academic year, and she worked closely with EM Core Faculty to develop an Evidence Based Medicine lecture series as part of the residency curriculum. During her time at Carilion, she has been selected as the Annals of Emergency Medicine Resident Editorial Fellow, was accepted into the University of Michigan’s NIH Neuro-EM Scholar K12 Pipeline program,  was selected as a participant in the Society for Academic Emergency Medicine’s (SAEM) Advanced Research Methodology Evaluation and Design 2025-2026 cohort with a full scholarship from the SAEM Academy for Women in EM, and was selected as a participant in SAEM’s Resident Medical Education Fellowship 2024-2026 cohort .

Dr. Klein’s current research focuses on identifying and addressing disparities in stroke risk - specifically the relationship between geography, social determinants of health, and stroke outcomes. In collaboration with faculty, she is developing an ED-based transient ischemic attack identification and stroke risk mitigation pathway to improve early risk factor detection and stroke prevention. A passionate advocate for enhancing stroke education among emergency physicians, Dr. Klein is also a prolific invited writer and national speaker in this area.

After completing her residency at VTC, Dr. Klein will continue her medical education and research training as a Critical Care Fellow in the Department of Anesthesiology at the University of California, San Diego. Through a T32-funded clinical and research dual fellowship, she will expand her work in stroke systems of care and prepare to sit for board certification in Emergency Medicine, Critical Care, and Neurocritical Care - continuing her mission to bridge research, education, and clinical excellence in the care of critically ill neurological patients.

Dear Colleagues,

As part of our commitment to continuous improvement, we want to make sure our department remains a valuable resource for your research and development work. With more than 2,500 subscribers to our newsletter, your feedback is essential in shaping how we share information, foster collaboration, and support innovation.

Please take a few minutes to complete our brief 10-question survey. Your insights will help us identify what’s working well and where we can improve to better serve you and the communities connected to our research. The survey is being conducted anonymously, which means we cannot determine who submitted responses. As a result, we’re unable to distribute the gift cards mentioned earlier. This survey will close on Friday, 11/7.

Thank you for sharing your voice and helping us grow stronger together.

Survey Link: https://redcap.link/m3nuwgw0

With appreciation,
Michael Wilson, MD, PhD

This month, we’re proud to recognize Maryann Hollen for her exceptional representation of our R&D team at the Roanoke GO Festival on Saturday, October 18, 2025. Maryann’s enthusiasm and initiative brought our innovative work to the local community, showcasing the creativity and dedication that define our department.

Her efforts at the R&D booth, complete with our new pint-sized t-shirts, made a fantastic impression and helped strengthen our community connections.

Thank you, Maryann, for going above and beyond to share our mission and inspire others with the spirit of innovation that drives our team!

Workday's Post Award Management module is designed to manage research awards and other types of sponsored projects.  As we prepare to launch the Post Award Management module, several key activities are underway to support a smooth transition and ensure that all necessary tools and resources are in place.

·  Fiscal year-end close will occur at the end of October, which must be completed before active awards can be imported into Workday.

·  In early November, life-to-date financial data for all sponsored projects will be loaded and validated in Workday. This foundational step will ensure accuracy across reporting systems.

·  Reporting dashboards are currently in development and will undergo thorough testing to confirm accurate data loading. Once finalized, these dashboards will be embedded into training modules and job aids, offering clear, visual guidance for managing sponsored projects.

·  In late November, a Post Award Management e-learning module will be released in Workday. This self-paced training will cover essential aspects of post-award project management, including financial oversight, compliance, and reporting.

·  Supporting documentation, including job aids, will also be available in the Employee Center to reinforce training content and provide ongoing reference materials.

 Thank you for your continued support as we enhance our Post Award Management tools and training resources.

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The ALTO-300-201 study is a Phase 2 clinical trial evaluating the safety and efficacy of ALTO-300 (agomelatine), an investigational adjunctive treatment for Major Depressive Disorder (MDD). This trial is part of a broader initiative to integrate precision psychiatry into clinical practice by leveraging biomarkers to optimize treatment outcomes.

Key Study Features:

• Design: 6-week double-blind, placebo-controlled phase followed by an optional 8-week open-label extension with guaranteed ALTO-300 administration.
• Population: Adults aged 18–70 with moderate to severe MDD, currently on a single antidepressant (SSRI, SNRI, or bupropion) for at least 6 weeks.
• Biomarker Integration: The study incorporates EEG, DNA samples, and cognitive assessments to explore predictive markers of treatment response.

Click here to read more.

Carilion Clinic and the Virginia Tech Carilion School of Medicine are pleased to welcome Dr. Albert Arias, an addiction psychiatrist and clinical researcher dedicated to advancing precision medicine in the treatment of substance use disorders.

Originally from Michigan, Dr. Arias earned his medical degree from Michigan State University’s College of Human Medicine. He completed his psychiatry residency and later served on the faculty at the University of Connecticut School of Medicine, followed by faculty appointments at Yale School of Medicine and Virginia Commonwealth University School of Medicine.

Dr. Arias has led numerous NIH-funded studies focused on developing and personalizing treatments for addiction. His recent NIAAA-funded R01 trial demonstrated promising results for zonisamide in reducing alcohol use, and his newly awarded NIDA UG3 grant will explore psilocybin-assisted therapy for cocaine use disorder.

With over 15 years of clinical trial and translational research experience, Dr. Arias combines pharmacogenomics, neuroimaging, and artificial intelligence to better understand why treatments work for some patients and not others—bringing psychiatry closer to truly individualized care.

Workday's Post Award Management module is designed to manage research awards and other types of sponsored projects.  As we prepare to launch the Post Award Management module, several key activities are underway to support a smooth transition and ensure that all necessary tools and resources are in place.

·  FY2025 financial activity will continue to be recorded in Lawson through September 30. Fiscal year-end close will occur by mid-October, which must be completed before active awards can be imported into Workday.

·  In early November, life-to-date financial data for all sponsored projects will be loaded and validated in Workday. This foundational step will ensure accuracy across reporting systems.

·  Reporting dashboards are currently in development and will undergo thorough testing to confirm accurate data loading. Once finalized, these dashboards will be embedded into training modules and job aids, offering clear, visual guidance for managing sponsored projects.

·  In late November, a Post Award Management e-learning module will be released in Workday. This self-paced training will cover essential aspects of post-award project management, including financial oversight, compliance, and reporting.

·  Supporting documentation, including job aids, will also be available in the Employee Center to reinforce training content and provide ongoing reference materials.

 Thank you for your continued support as we enhance our Post Award Management tools and training resources.