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Clinical Trials Office Newsletter
June 2026 Edition
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An exciting milestone at RWJUH was reached this April when a patient received an investigational gene therapy agent intracranially in a First-in-human (FIH) Study Investigating the Safety, Tolerability, and Efficacy of AMT-260 in Adults with Unilateral Refractory Mesial Temporal Lobe Epilepsy (MTLE) Administered via Magnetic Resonance Imaging (MRI)-guided Convection-enhanced Delivery (CED) Gene Therapy for Temporal Lobe Epilepsy (GenTLE.) Dr. Robert Gross (RWJMS-Neurosurgery) is the study Principal Investigator.
Rutgers is the only site in NJ and one of three in the Northeast (Johns Hopkins and Mass General are the other two).
Treatment options for patients with refractory epilepsy are currently limited: The treatment most likely to result in freedom from seizures is surgical resection of the part of the brain where the seizures begin. Since surgery may lead to cognitive challenges, language problems and memory loss, many patients understandably decline. As such, there is an acute need for better, lower risk options.
This unblinded, open label study enrolls participants with Mesial Temporal lobe epilepsy (TLE) whose seizures cannot be controlled by anti-seizure drugs. Treatment involves a single infusion of gene therapy (AMT-260) delivered via a cannula through a bore hole directly into the hippocampus area of the brain, through a procedure known as MRI-guided convection-enhanced delivery. The infusion takes about one hour of the approximately 8-hour procedure.
Following the surgery, participants are required to keep an electronic seizure diary, and to return to the RWJMS CRC for follow-up study visits.
Congratulations, Dr. Gross, the RWJUH Neurosurgical Team and the RWJMS CRC for enrolling into this landmark study!
| | The RWJUH Neurosurgical Team | | | |
RWJMS Clinical Research Center Team
Therese Pagulayan, Liz George, Fei Chen, Anoja Warusawithana, Sherri Gzemski and Sheila Redding
| | | 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 Rutgers Health study teams! | | |
Scenes from the
Newark and New Brunswick
Clinical Trials Day events, May 20th 2026
| | Using social media to recruit for clinical trials - An updated toolkit from the Recruitment Innovation Center | | |
Monday, August 3rd, 2026
12:00 pm
| | Matt Schorr, Stephanie A. Mayers, MEd, Sarah Cook MPH & Mariela Rodriguez, MPH | | In this webinar, the Vanderbilt Recruitment Innovation Center (RIC) will present their updated Social Media Outreach & Recruitment Toolkit. This resource is designed to help researchers and study teams understand the benefits of social media and provide practical guidance on using these platforms to support recruitment for research studies. Updates to the toolkit include insights into social media usage patterns, guidance on planning an advertising budget, strategies for preventing fraud, new case studies, and information on additional social media platforms. The toolkit was developed in close collaboration with the RIC Community Advisory Board. | | Why Reviewing Demographic Data from Epic Matters | | |
As we continue strengthening the quality and inclusiveness of our research, it’s important to take a closer look at the demographic data imported from Epic and applied in the CRA Console during initial participant registration in OnCore. When finding a participant in OnCore, fields such as race, ethnicity, and gender are often populated as “Unknown.” While sometimes appropriate, these unknown values can also arise simply because the data was not verified or updated at enrollment.
When these unknown values carry over into analytics, they can unintentionally mask the rich diversity of our participant populations and underrepresent the hard work our study teams are doing. To ensure our research truly reflects the communities we serve, please take a moment to review demographic fields during data entry, and, when appropriate, edit and correct "Unknown" selections.
A quick check today leads to clearer insights tomorrow—and helps us tell the full story of our research.
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Rutgers HRPP Guidance on AI in Human Subjects Research
| | The Rutgers HRPP Office recently released new content on their website on Artificial Intelligence in clinical research. This comprehensive guidance provides best practices, suggested consent form language and links to additional resources. Check it out! | | FDA Enforcement Update: Results Reporting for Applicable Clinical Trials (ACTs) | | |
On March 30, 2026, investigators across the U.S. began receiving unusual FDA notifications regarding their registered records on ClinicalTrials.gov. Subsequently, in the FDA News Release on April 13, 2026, the FDA announced that the agency had issued notices to more than 2,200 sponsors and researchers, requesting the submission of required clinical trial results information to clinicaltrials.gov. Coverage of this development has also appeared in the New York Times - see here.
As part of its risk-based compliance efforts, the FDA also indicated that Responsible Parties may receive Pre-Notices of Noncompliance and Notices of Noncompliance related to unmet results reporting requirements under federal law.
The Rutgers ClinicalTrials.gov Support Team has been actively monitoring this development and working diligently to ensure compliance for all Applicable Clinical Trials (ACTs) registered on clinicaltrials.gov.
For assistance with ClinicalTrials.gov requirements or questions about any registered records, please contact Rutgers ClinicalTrials.gov Support at rutgersctgsupport@research.rutgers.edu.
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University Hospital Preparing for Joint Commission Survey
University Hospital-Newark is currently preparing for an upcoming Joint Commission survey. As part of this effort, UH leadership is asking that research teams conducting studies at the Hospital ensure that regulatory documentation, study records, informed consent forms, and SOPs are current and readily available for review, in case the auditors select a study participant for review. Research teams should also verify that protected health information (PHI) is appropriately secured and that research areas, workspaces, and study storage locations are organized and free of unnecessary clutter to support patient privacy, safety, and regulatory compliance.
The Joint Commission survey serves as an important opportunity to demonstrate continued commitment to patient safety, quality of care, regulatory compliance, and excellence in clinical research. The continued collaboration of investigators and study teams is greatly appreciated. The hospital will share additional guidance as needed and wishes to express their gratitude for the continued dedication to advancing clinical research at University Hospital.
| | Important Process Change for Users of RWJBH Radiology Services | | |
In a joint effort with RWJBH and University Radiology Group, the Clinical Trials Office has been working to identify systemic blind spots and inefficiencies related to clinical research billing revenue cycle processes, particularly for procedures that entail a professional component. In cases where radiology tests are performed at certain RWJBH locations, including 10 Plum Street, University Hospital - New Brunswick, and Morris Cancer Center, the radiologist interpretation is outsourced to URG, who is in turn responsible for submitting claims and charging patients/insurance for the professional component of the procedure. Meanwhile, the process for reviewing and routing RWJBH charges for the technical component through Epic does not change.
Although RWJBH and URG are exploring the possibility of an integration between their respective EMRs to automate the process, at present, it is the study teams' responsibility to notify URG in advance of research imaging appointments to ensure URG does not bill the patient/insurance. In the interim, study teams must email this .pdf form to URG, effectively immediately. The form serves a dual purpose: first, to notify URG that a radiology procedure should not be billed to the patient/insurance, and second, to provide URG with the relevant contact information of study staff that can verify the participant's procedures, as well as the person who will ultimately process the URG invoice and payment. The form can be found HERE and contains further instructions, but if there are any questions about this interim process or the form itself, please contact clinicaltrials@rbhs.rutgers.edu.
Of note, this change in process does not apply to radiology services performed at independent URG locations.
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Clinical Research Pets of the Month
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June's clinical research pets of the month are Cash and Shiloh. Their dad is Matt Wexler, clinical contract specialist for the Clinical Trials Office.
Shiloh is a golden doodle (3/4 doodle) who looks three quarters golden and that's actually how Katherine (her mom) originally came into her possession. The original family didn't want Shiloh since she didn't look golden doodle enough, allowing Katherine to swoop in and claim her. Shiloh loves people, squirrels, night squirrels (rats), and barking at dogs from her favorite chair. Shiloh hates rain, vacuum cleaners, and camping.
Cash is a black cat who grew up on the mean streets but seems to have been very bad at it. He was covered in cuts when he found Matt and Katherine and followed them home. Cash loves car rides, food, walking on keyboards, and the trying to escape into the refrigerator. Cash hates being kept from exploring, being licked by Shiloh, and when Shiloh steals his toys.
It took a while for Shiloh and Cash to get along. Shiloh wanted to put Cash in her mouth and Cash wasn't very happy being put in harm's way. But after enough treats were shoved in Shiloh's mouth while she wasn't trying to put Cash in it, they are now friends.
| | Congratulations to Cash, Shiloh, and Matt! | | | | |