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Clinical Trials Office Newsletter
April 2024 Edition
We very much welcome your comments and suggestions – please drop us a line with your thoughts at clinicaltrials@rbhs.rutgers.edu.
Research Spotlight:
React-AF
This month we are highlighting REACT-AF (The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation), which is being conducted by the RWJMS Cardiology research team under the direction of Dr. Partho Sengupta (PI).
 
REACT-AF seeks to determine the best strategy of using oral anti-coagulants to prevent stroke in patients with Atrial Fibrillation (AF.) AF is the most common heart arrythmia and one of the most important causes of stroke. This study, which will ultimately enroll more than 5000 patients, is supported by the NIH and is being conducted across 100 academic and private practice sites throughout the country. RWJMS was invited to participate because of our affiliation as a Clinical and Translational Science Award (CTSA) awardee through Trial Innovation Network (TIN.)
 
Once a patient is diagnosed with AF, the current standard of care is to take oral anti-coagulants continuously to prevent stroke. While the risk of stroke is greatest during recurrent episodes of AF (which may be infrequent), patients on continuous oral anti-coagulants are continuously exposed to the risk of bleeding. Thus, there is a need to balance the risk of stroke vs. the risk of bleeding in patients with AF. 
 
In REACT-AF, patients are randomized to either receive the current standard of care with continuous oral anti-coagulants vs a novel, experimental approach using an Apple smartwatch equipped with an AF-detecting algorithm. In the experimental arm, patients are only prescribed anticoagulants if AF is detected through the smartwatch algorithm and the episode lasts more than one hour. Anticoagulants are then discontinued after 30 days, provided there have been no further AF episodes.  
 
RWJMS has been a top recruiting site study-wide for the past three months, including landing in first place in the recent “March Madness” competition! Congratulations, Dr. Sengupta (PI), Dr. Maglione (Co-I), Dr. Kostis (Co-I) and the RWJMS Cardiology team for the stellar work on this incredibly important trial!
Left to Right: Omar Hamam (lead CRC), Dr. Sengupta (PI). Dr. Kostis (Co-I). Dr. Yanamala (CRU Director), Dr. Maglione (Co-I), Heena Gandhi (RC), Anita Subramanian (CRC-II) and Christopher Stradford (CRA).
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!
Calling all trailblazers! This year we will be marking Clinical Trials Day (which celebrates the first randomized clinical trial in 1774) by hosting events on both campuses. This year’s theme is to celebrate the work of clinical research professionals (i.e. the “Trailblazers among us.”) If you have a clinical trial you would like to promote, or would like to highlight your group’s accomplishments, please join one of our events. To be a part of the New Brunswick event, please contact Therese Pagulayan tup1@rwjms.rutgers.edu or for Newark, reach out to Yanille Taveras taveraya@njms.rutgers.edu. Scan the QR code for more information on Clinical Trials Day
Upcoming Events
Rutgers Health
Clinical Research Work Group Call
Monday, May 13th, 2024
12:00 pm
Hila Berger, MPH, CIP, CHC
Assistant Vice President for Research Regulatory Affairs
Welcome back for another joint call for our work group series. Our speaker will be Hila Berger. She will speak about the eIRB+ rollout and other important updates from Rutgers HRPP.

Full agenda to be sent out in early May.
Paying participants in Research: Time to Move Forward...
Monday, May 6th, 2024
12:00 pm
Neal Dickert, MD, PhD
Dr. Dickert will discuss practical and ethical considerations related to paying research participants for participation. In particular, he will discuss available data that suggest many traditional concerns about payment are not grounded in evidence, address the potential for payment to function differently in different research contexts, and consider the potential role of payment in addressing rather than exacerbating concerns about distributive justice.
RWJMS Corner
Reminder: RWJUH Institutional Research Committee (IRC) requirements
As a reminder, any study which uses RWJUH resources requires review and approval by the hospital’s IRC (formerly known as the “RUG.”) This committee meets monthly on the third Wednesday of each month at 10:00 AM. The link to submit a study is : https://thebridge.rwjbh.org/rwj-university-hospital/rug-form.aspx
 
We are kindly remind you to forward a copy of your IRC submission and your approval letter once you receive it to clinicaltrials@rbhs.rutgers.edu
NJMS Corner
University Hospital-Newark Laboratory Reference Range Changes
See below for an important announcement about key reference range changes.
OnCore Quick Tip:
How to document summary accrual
In some scenarios, OnCore can allow for limited subject accrual information, without requiring individual subject PHI. If the CTO deems a study suitable for “Summary Accrual Only,” you’ll only need to document of the number of subjects enrolled and general demographic information periodically. Below is a quick guide for documenting summary accruals.

As seen in the screenshot below, you want to start in PC Console. Next, go to Accrual on the left sidebar, then click Update.
You will see 4 required fields on the next page. Please fill out the date ranges of the accrual documentation using from and thru dates (CTO requires a minimum of reporting accrual quarterly). Please use research center for "Internal Accrual Reporting Group" unless you have affiliates at Rutgers who are recruiting in parallel. This would be documented separately. We encourage study teams to document demographic data if available, but it is not a required field.

The last step is to click Add and then Close.
Clinical Research Pets of the Month
April's clinical research pets of the month are Vasco and Smokey. Their pet parent is Anoja, regulatory coordinator for the Clinical Research Center at RWJMS.

Nestled in a cozy little home filled with warmth, lives two furry friends named Smokey and Vasko. Smokey, with his luxurious coat of ebony that shimmered like the night sky, has a passion for food and cuddles, while Vasko, a mischievous replica with a playful twinkle in his one remaining eye, is a catalyst for chaos. It's a mystery where Vasko picked up the habit of standing on his hind legs in order to be pet.

In the quiet moments of dawn, Smokey can often be found perched by the windowsill, watching the birds and squirrels outside with curiosity. Meanwhile, Vasko will be exploring every nook and cranny of the house, his adventurous spirit leading him to new discoveries. Despite Vasko's playful stunts, Smokey was the more active of the two (He used to play fetch). But since Vasko's arrival and his monopolization of the toys, Smokey has taken on a more mature air, content to watch from the sidelines as Vasko dashes about in his energetic pursuits.

Their days are filled with playful antics and affectionate moments. Vasko patiently grooms Smokey's fur, while his gentle purrs echo through the room. He then chases after his favorite feather toy with boundless energy, his one-eyed gaze focused intently on his elusive prey. He dashes around, pouncing to catch it, and then happily drags the prized trophy over to the couch afterwards.

But amidst their playful acts, jealousy simmers between the two, in a subtle dance of rivalry and companionship. While Vasko's jealousy often erupts in intense stares and the occasional pounces, Smokey's envy is a quieter affair. The one thing they both agree on is eagerly escorting Anoja to the food bowls whenever they anticipate a meal.
Anoja has had Smokey for a few years now, whereas Vasko was a more recent addition after the passing of Sheigwa, a member of the family for almost 19 years. Seeing Vasko (who had only recently lost an eye) at the shelter, it seemed fitting to welcome him to the home. The void from Vasko's lost eye seemed to mirror the recent loss of Sheigwa, forming a bond through shared loss and understanding.
They are more than just pets; they are cherished members of Anoja's family, bringing warmth and boundless joy to every corner of the home. Every time they curl up together, it is clear that Smokey and Vasko are truly meant to be together.
Congratulations Anoja, Smokey, and Vasco!
If you want your favorite pet featured in the next newsletter, reach out to us via clinicaltrials@rbhs.rutgers.edu