Clinical Trials Office Newsletter
December 2024 Edition
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Research Spotlight:
Abata 101-PMS-101
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Dr. Vikram Bhise (RWJMS-Neurology,) with the help of the RWJMS Clinical Research Center, recently launched Abata 101-PMS-101, a phase I cell therapy trial for progressive multiple sclerosis (p-MS,) a particularly debilitating form of the illness. While cell therapy trials have been on-going for a number of years in Oncology, to our knowledge, this is the first cell therapy trial to be up and running here for non-oncology.
Abata 101-PMS-101 (which was recently granted fast track designation by the FDA) involves treatment with autologous regulatory T cells (Tregs) which naturally serve to suppress inflammation and autoimmune disease and to promote repair. In this intensive, first-in-human trial, the participant’s white blood cells are first collected on site through leukapheresis and then shipped to the Sponsor’s manufacturing facility. ABA-101 is then created using the participants Tregs and inserting genetic material via a lentiviral vector. The treatment is then shipped back to the site and delivered to the participant by infusion. As is typical with cell therapy trials, infusion of the therapy entails inpatient admission. If successful, this treatment would represent a major breakthrough in caring for patients with p-MS, as treatment options are currently limited.
12–18 participants will be recruited nationally, with the hope of recruiting 3 to 5 at Rutgers. Embarking on a cell therapy trail and getting it up and running is immensely complex, so please join us in congratulating Dr. Bhise and the RWJMS CRC team for being our local trailblazers! Click here to learn more about this trial.
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Please shoot us an e-mail to clinicaltrials@rbhs.rutgers.edu if you have a new study, grant award or publication from your area that you’d like to share with your fellow RBHS study teams! | |
Regulatory Tip of the Month
A message from the Rutgers IRB:
Meet the HRP-503+ IRB Protocol Guide for eIRB+
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This brand new resource is intended to help researchers prepare their eIRB+ application. Researchers may use this as a worksheet as they prepare their application narrative. This document should not be uploaded/submitted in eIRB+.
Why did the IRB create this?
When eIRB+ launched in April 2024, the content from the Rutgers protocol templates were integrated into the eIRB+ application. As a result, the prior protocol templates (HRP-503a, HRP-503b, and HRP-503c) no longer needed to be attached to new applications. However, as some researchers would like to plan their submission outside of eIRB+, this tool can be used for just such needs.
Are researchers required to use the HRP-503+?
Researchers are not required to use the HRP-503+. The document is NOT intended to be submitted with the IRB application in eIRB+. The document is meant to be used as a tool for preparing the IRB application.
What is in the document?
The document is a combination of the prior protocol templates (HRP-503a, HRP-503b, and HRP-503c). This means that some sections may not be applicable to every investigator’s research.
This document gives researchers the opportunity to draft and plan their responses before entering them into the eIRB+ application. The HRP-503+ document is annotated with the corresponding eIRB+ application sections so researchers will know where in the eIRB+ application to copy/paste the responses they drafted outside of the system.
What is the alternative to using the HRP-503+?
Researchers may choose not to use the HRP-503+. Instead, researchers can go right to the application in eIRB+ and type in their responses to questions directly into the form.
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Investigator Leave of Absence or Departure | |
There is still time to register! | |
Leveraging Artificial Intelligence to Summarize Scientific Abstracts in Lay Language for Increasing Research Accessibility and Transparency | |
Monday, January 6th, 2024
12:00 pm
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Cathy Shyr, PhD, Postdoctoral Research Fellow | |
Timely and effective return of aggregate study results plays an essential role in informing the public about clinical findings to promote trust and transparency in the research process. This session will discuss the approach of leveraging OpenAI's ChatGPT-4 to generate lay summaries and implementing them on ResearchMatch, a national clinical study recruitment registry, to enable cost-effective and scalable return of study results. The speaker will describe the process of operationalizing this approach, including prompt engineering, study design, and rigorous evaluation of researchers' and volunteers' perception of AI-generated summaries. In addition, the speaker will share lessons learned, including opportunities and challenges of using AI to enhance research accessibility and transparency. | |
Clinical Trials Office
Upcoming Events:
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Clinical Trial Agreements: The Hows, Whats, and Whys | |
Monday, January 13th, 2025
12:00 pm
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Samuel Lee, JD, Clinical Contracts Manager, Clinical Trials Office | |
PI Roles and Responsibilities: A Review of FDA 483's and BIMO Inspection Findings | |
Monday, March 10th, 2025
12:00 pm
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Nadina Jose, MD
Assistant Professor, MS Clinical Research Management, SHP Co-Lead NJ ACTS Workforce Development
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Jason Walker, MSHI, BSN, RN
Doctor of Health Informatics (DHI) student
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John Haggerty, BA, NRP
MBS Candidate - Medical Scholar Track
Rutgers Graduate School of Biomedical Sciences
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Coming in May 2025:
Members of the NJ ACTS GREAT (Genetically Informed Research, Education, and Treatment) core will present on Genetic Testing in Clinical Research. Stay tuned for more information!
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Find a Clinical Trial Tool
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In August, the CTO launched the "Find a Clinical Trial" tool (accessible from the NJ ACTS home page) to enhance the visibility of research efforts conducted across Rutgers. This user-friendly tool allows researchers, clinicians, and the public to easily discover and access information about open clinical trials by using simple search criteria. The goal is to raise awareness of the clinical research we do and help people find the right trials for their needs.
To access the tool, visit https://go.rutgers.edu/clinicaltrials.
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University Hospital Updates: Message from Arleen and Eduardo | |
EPIC Resolute Implementation & Research Functionality at University Hospital
On November 10th, we officially launched the implementation of EPIC Resolute and the research functionality at University Hospital. The Office of Clinical Research Services would like to extend our heartfelt thanks to all Rutgers Research staff for their dedicated work in making this "Go Live" a success. While we’ve encountered a few challenges along the way, rest assured that we’ve been actively communicating your concerns and compiling a list of items to refine in collaboration with UH-IST and EPIC.
Upcoming Training:
We are excited to announce the upcoming Cadence class for Research Registration and a Slicer/Dicer class focused on research. Stay tuned for more details on these sessions!
Additionally, this winter, we will be hosting an "open discussion session" for NJMS research staff. Join us as we discuss the shared Research Enterprise with our office and Executive Leader, Franklin Hickey. More information will follow soon.
Billing and Documentation Reminders:
If you come across a study that requires a billing grouper to reduce or eliminate billing review, please contact Arleen Wallen at wallenar@uhnj.org or at 973-972-7809.
A couple of important reminders for all research staff:
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Please refer to the Billing Grid in Oncore for your studies to identify what is categorized as RC (Research Charges) or PR (Professional Charges) in your billing reviews.
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Ensure there is a Research Note for all visits so we can accurately compare the visit column during billing reviews. This helps minimize the need for charge returns.
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A Research Note should also be written to explain the Informed Consent process.
You can edit the Research Note Template or create your own templates to better suit your needs.
Once again, thank you for all your hard work and dedication as we continue to refine this process together.
Happy Holidays!
Arleen Wallen & Eduardo Torres
University Hospital, Office of Clinical Research Services
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Molly recently joined RWJMS in the Department of Medicine as the Clinical Research Project Manager for Gastroenterology. She comes to Rutgers with 9 years of clinical research experience at Northwell Health, where she previously worked with Principal Investigators (and new RWJMS faculty members) Dr. Arvind Trindade and Dr. Petros Benias in Endoscopic Research. She is eager to continue collaborating with Drs. Trindade and Benias in their research endeavors here at Rutgers. Please join us in welcoming Molly to Rutgers Health! | |
Clinical Research Pet of the Month
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December's clinical research pet of the month is Buster. Buster’s pet parent is Sandy Burrows, NJ ACTS Administrative Director (who you may have seen from time to time on the New Brunswick campus with a puppy wearing a distinctive green cape in tow.)
Buster has had an incredible journey and a life in service to people and his fellow dogs. He started out training to be a Seeing Eye Dog and preparing to help someone in need. Though he didn’t continue down that path, he found a loving home where he became a cherished family pet. But Buster’s story doesn’t end there—he’s now a hero in a different way. As a blood donor, Buster helps save the lives of other dogs in need. His selfless contribution shows that even when life takes you on another path, there are always ways to make a difference and to be a new kind of hero.
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Congratulations to Buster and Sandy! | | | | |