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Clinical Trials Office Newsletter
October 2023 Edition
We very much welcome your comments and suggestions – please drop us a line with your thoughts at clinicaltrials@rbhs.rutgers.edu.
Research Spotlight
New Jersey Medical School is on the (TB) Map
This month we are highlighting the work of the NJMS Emerging Pathogens group. Under the leadership of Jerry Ellner, Padmini Salgame, David Alland, and (more recently) W. Evan Johnson, the group has leveraged its deep expertise in basic science, translational, bioinformatics and clinical research to build an astounding number of international collaborations to develop new tools to control Tuberculosis (TB.) Funding from all sources totals about $41 million annually. The map above illustrates their current global reach. 

Current major projects include: Bacterial and Host Heterogeneity in TB Latency, Persistence and Progression (TB Research Unit), Brazil, Uganda; Bacteria and Host in TB Transmission, Brazil, Uganda; Feasibility of Novel Diagnostics for TB in Endemic Countries FEND-TB, Moldova, Peru, South Africa, Uganda, Vietnam; Novel and Optimized Diagnostics in Pediatric TB, Peru, Uganda; and Regional Prospective Observational Research (RePORT)-TB, Brazil, China, India, Indonesia, Philippines, and South Africa.

Under each grant, the protocol design typically entails recruitment of microbiologically-confirmed TB patients (adults and children) and their close contacts, with the collection of sputum, blood and other samples to study host and bacterial factors (and “biomarkers”) that are associated with progression from TB infection to active TB or predict poor response to standard TB treatment. The group has been instrumental in the development of new diagnostics for TB, including GeneXpert, which was endorsed by the World Health Organization in 2010 for use in TB endemic countries. The development of this tool, which allows for diagnosis of TB (as well as sensitivity to standard drug regimens) within about 90 minutes, significantly reduces the length of time required to initiate effective treatment when compared to the previous gold standard of bacterial culture. Diagnostic platforms using AI approaches - including commercial algorithms from digital chest x-rays, digital stethoscope, point of care ultrasound (POCUS), and cell phone cough monitoring platforms are also being evaluated.

The group also trains Ugandan students at NJMS in basic and translational research through a Global Infectious Diseases Training Program funded by the Fogarty International Center.

In addition to the project leaders, the program is supported locally by NJMS faculty members Linda Xie, Sheetal Verma, and Jason Yang. Key components of the NJMS program are the Data and Operations Management Center led by Kiranjot Arora, David Hom, Emily Douglass and Ann Tufariello and the Administrative Leadership, Francesca Escaleira, Audrey Mioli, Lorraine Luciano-McKeon, and Joanna Radman. The work, however, would not be possible without the countless investigators and study team members in the host countries as well as scientific collaborators at other academic centers in the US and abroad.
 
For more information on this work, you can visit the following project specific websites: 
Pictured from the top: Jerry Ellner, W. Evan Johnson, Padmini Salgame and David Alland.
Staff and facility, Jinja Hospital, Uganda. 
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!
CTO Orientation for new research staff
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Most of us can remember what it was like to start working here at Rutgers in clinical research: a seemingly endless list of processes to learn and with no unified way to discover what is needed. To help navigate these complexities, the CTO has launched a new orientation program for clinical research staff. 

If you or someone you know is new to conducting clinical research at Rutgers, we want to help! To request a personalized orientation session and onboarding checklist, new staff can complete a brief survey to tell us about his/her expected responsibilities and about any prior work experience in clinical research. We will then work with the employee and their supervisor to supplement any planned orientation with a personalized session to review critical areas such as working with our partner hospitals, getting access to various software systems, etc. The scope of the CTO’s orientation will be focused on relevant policies and procedures and accessing the resources available for clinical research at Rutgers. Send us an email to clinicaltrials@rbhs.rutgers.edu if you have any questions.
CRC Badge: Spots are available for the November Cohort!
Interested in an Entry-level Position as a Study Coordinator? The Rutgers School of Health Professions in collaboration with the New Jersey Alliance for Clinical and Translational Sciences (NJ ACTS) developed a 6-week academic badge especially designed for Clinical Research Professionals, novice investigators, and students with little to no clinical research or pharmaceutical experience who would like to participate in clinical research at an Academic Medical Center (AMC) functioning as a "study coordinator". Registration for the November cohort is still open, limited spots are available!

To learn more about the CRC Level-1 Badge REGISTER HERE!
RBHS is now Rutgers Health: What you need to know about Branding
In August, University Communications and Marketing (UCM) announced the change to the visual identity system that will make the Rutgers R the primary logo for the university. In case you missed that communication, you can read it here, and if you missed the information sessions they held in September, you can listen to the recorded Zoom meeting. The transition to the new system is now underway and eight high-level Rutgers R marks are now available for use by the Rutgers community.

How Can I Access the Main Rutgers R Marks?

The graphic files for these main marks can be downloaded after you log in to the signature generator:
Rutgers, GSK, & Deep 6 AI publish AI-powered algorithm
In a newly published study, Rutgers, GSK, and Deep 6 AI teamed up to develop a COPD exacerbation risk algorithm by leveraging artificial intelligence (AI) to tap into both structured and unstructured clinical data in electronic health records (EHRs). 
Mining unstructured EHR data (e.g., clinician notes) allows researchers to discover clinical characteristics of patients with exacerbation that are not available in traditional claims data or coded EHR data. 
 
Learn more about how they developed the AI-powered algorithm and the findings.
Upcoming Events
Social Media Recruitment with Meta Restrictions
November 6th, 2023
12:00 pm
This webinar will provide information on how to create Meta ads for study recruitment. In January 2021, Facebook (now Meta) changed their privacy policy, making it more difficult to target ads to people based on race/ethnicity, sexual orientation, religious affinity or anything that would be protected under HIPAA (i.e., cancer). This privacy update made targeted recruiting for clinical trial more difficult. During this presentation, Brooke will explain how to build a social media ad for recruitment while also focusing on workarounds of Meta restrictions.
RWJMS Corner
REMINDER! Instructions for scanning signed consent forms into the RWJBH Epic System are available on the CTO website. Note that this important requirement from our RWJBH hospital partners is necessary in order to comply with JCAHO standards. It will also assure that a copy of the consent form is easily accessible to any member of the patient’s care team who needs to see it.

Should you encounter any problems following the instructions, please create an EPIC service now ticket (as directed at the end of the document.) If you have any questions about this directive from RWJBH, please e-mail clinicaltrials@rbhs.rutgers.edu  
NJMS Corner
NJMS Clinical
Research Workgroup
December 4th, 2023
12:00 pm
Agenda TBA soon!  
OnCore Quick Tip:
Managing Optional Segments
  1. Log into Oncore
  2. Subject Console -> Click on subject -> Calendar -> Manage Optional Segments
  3. Select any applicable optional visits in the pop-up window.
  4. Submit
Clinical Research Pets of the Month
October's pets of the month are Ellie and Stella! Their human is Sherri Gzemski, Business manager of the CRC.
 
Ellie is an 8-year-old Brittney Spaniel and has been with her family since she was a pup. She is a free spirit and enjoys many outdoor activities such as hiking, fishing, and paddleboarding. She also spends much of her free time monitoring the perimeter of any property her humans occupy in order to keep them safe from rabbits, squirrels, chipmunks. An airtag can be found on her collar in the event she finds trespassers and gets carried away while chasing them from her territory.
 
Stella is a 9-year-old Shitzu who came to live with her family 3.5 years ago after her previous human passed away. Stella and Ellie were already old friends, so she fit in with the family instantly. The two can be found having wrestling matches throughout the day (Stella usually wins), especially when their humans are trying to hear the TV. Stella loves fashion and is very affectionate. She loves to snuggle and is rarely 3 feet from either of her humans and can often be found staring out the window anxiously waiting for them to get home from work so she can get more cuddles. 
Congratulations Ellie, Stella, and Sherri!

If you want your favorite pet featured in the next newsletter, reach out to us via clinicaltrials@rbhs.rutgers.edu