Clinical Trials Office Newsletter
October 2024 Edition
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Shobha Swaminathan, MD, FIDSA, Professor of Medicine and Medical Director of HIV Programs, is leading the team at New Jersey Medical School Research with a Heart in two Phase II collaborative studies to assess lenacapavir, an investigational long-acting HIV prevention option. The studies are sponsored and funded by Gilead and are being implemented through the HIV Prevention Trials Network. Named PURPOSE 3 and PURPOSE 4, these studies are targeting cisgender women and people who inject drugs in the US respectively. These trials will assess the safety, acceptability and pharmacokinetics of lenacapavir administered via injection every 6 months as a pre-exposure prophylaxis option. Fun fact - Dr. Swaminathan is also serving as the national Protocol Chair for PURPOSE 3, an awesome achievement that continues to underscore her commitment to advancing women’s prevention options.
Congratulations, Dr. Swaminathan and the NJMS Research with a Heart team on launching this important initiative!
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(Left) Kaylee Chan, BS, Data Manager (Right) Asha Chintala, MPH, Clinical Research Associate | |
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!
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Research Resources Workshop Wednesday (R2W2) Series | |
Wednesday, October 16th, 2024
4:00 pm
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Reynold Panettieri Jr, MD | |
Offered as part of the ongoing R2W2 series, this session will provide an overview of the resources and services available through NJ ACTS, the Rutgers-led Clinical and Translational Science Award. | |
Regulatory Tip of the Month:
Medicare Coverage Analysis
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As part of study start-up activities, the CTO conducts a Medicare Coverage Analysis (MCA) for all clinical trials. You wouldn’t be alone if you don’t know exactly what that means or why it is done, so we thought we’d provide an explanation.
The origins of the MCA date back to the year 2000, when the Centers for Medicare and Medicaid Services first introduced the Clinical Trial Policy (National Coverage Determination on Routine Costs in Clinical Trials - NCD 310.1), which requires Medicare to cover routine care costs in qualifying clinical trials. Then, in 2014, The Affordable Care Act extended this requirement to all other insurers. While sponsors, particularly industry sponsors, often offer to cover all procedures in the study budget, many do not and expect that certain study procedures will be billed to a participant’s insurance. This is particularly common in cancer clinical trials, but we also see it other therapeutic areas.
The MCA is one of the first study start-up tasks we do, because it forms the basis for cost gathering and for negotiating the budget.
The first step in conducting an MCA is to determine whether the study is “qualifying” per the Clinical Trial Policy’s criteria. This is a specific and detailed definition, but it essentially includes any study with “therapeutic intent,” where the objective is to evaluate the efficacy (as opposed to safety or dose tolerance) of the investigational drug. Furthermore, a study can be “deemed qualifying” if it is conducted under an IND or if it is funded by one of the branches of the federal government (i.e. NIH, CDC, AHRQ, CMS, DOD or the VA). Thus, most of the externally sponsored clinical trials we conduct at Rutgers are “qualifying.”
The second step is to determine which procedures required in the study schedule of events would be considered “routine care,” meaning the procedures would be performed whether the patients were on a study or not (More information on RC vs. SOC here). Additionally, NCD 310.1 allows us to charge certain costs of the administration of an investigational drug, and the costs of monitoring for adverse events to Medicare.
The end result of an MCA is the billing grid in OnCore. You’ll notice that each item on the schedule of events has a billing designation of either Routine Care (RC) or Pure Research (PR.) The billing grid then serves as the guide for how each of the charges should be billed (i.e. whether to the participant’s insurance or to the study.) As always, please shoot us an email at clinicaltrials@rbhs.rutgers.edu if you have any questions about this process or how to find your study’s MCA.
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Faster Together, Enhancing the Recruitment of Marginalized Communities in Clinical Trials | |
This course aims to teach people how to enhance the recruitment and retention of individuals from minoritized and marginalized communities in clinical trials. We begin by discussing the importance of diversity in clinical research, the lasting impact of past research abuses, and barriers and facilitators to research participation. Next, we explore community engagement principles, effective communication strategies, ways to increase community knowledge and awareness of clinical research, and outreach to community providers. Last, we discuss recruitment planning, person-centered consent, and retention.
The course duration is listed as 8 weeks. However, you can work at your own pace and finish the course faster, if so desired. There is no cost to participate in the course; however, there is a fee for obtaining a completion certificate. Financial aid options are available.
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Rutgers Health Clinical Research
Work Group
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Monday, October 28th, 2024
12:00 pm
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Jonathan Carter, MBS
Business Systems Analyst
Clinical Trials Office
New Dashboards and Reporting Capabilities Through OnCore
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We are back with another joint work group call. Jonathan will be showing the new reporting capabilities through OnCore, Rutgers’ clinical trial management system. Detailed agenda will be sent closer to the meeting date. See you then! | |
Friday, October 18th, 2024
12:00 pm
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Joshua Betz, MS, Michael Rosenenblum, PhD, Kelly Kidwell, PhD, Jonathan Casey, MD & Frank Harrell, PhD | |
Join the JHU Trial Innovation Center for a virtual symposium highlighting contemporary methods for the efficient design and analysis of clinical trials. New tools and software will be discussed, and attendees will be provided with real-world examples using these innovative methods to aid in producing effective trials. | |
With the UH-Newark Epic Research/Resolute Module implementation going live at the end of this month, UH-Newark and the Clinical Trials Office have been working to assemble the study information that is required to be imported into Epic’s Research Module.
To ensure this information to accurate and up to date, the UH Epic team will be on-site on Tuesday (10/29) and Wednesday (10/20) between 9-12 pm and 1-4 pm at UH Cancer Center in Room D1150 to assist in validating your study information, as well as “associating” each of your active participants to the new Epic study record (to replace research flags).
We are asking study teams to have at least one study team member drop-in to perform this activity. If you are unable to attend any of these sessions, please contact any of the below:
Mary Uloth muloth@epic.com
Jack Kiley jkiley@epic.com
Arleen Wallen wallenar@uhnj.org
Eduardo Torres torresed@uhnj.org
Alexandra Young ay350@rutgers.edu
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Click here for the agenda
Register by scanning the QR code or clicking the button below
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Clinical Research Pet of the Month
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October's clinical research pet of the month is Spangler. Their pet parent is Travis Bergmann, Research Manager for RWJMS Cardiology.
Spangler is a two-year-old Bernese Mountain Dog, named after the Ghostbuster Egon Spangler. Spangler gives unconditional love and expects it to be reciprocated. He is also uncoordinated and has no ability to slow down once he is at his top speed, so his 90-pound body just slams into walls or anything that comes in his way. Spangler is loyal but so lazy. His favorite treats are frozen mangoes and cheese. His favorite activity is to deposit fur around the house.
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Congratulations to Spangler and Travis! | | | | |