This month we are highlighting a new investigator-initiated trial funded by a grant through the NIH/National Institute on Drug Abuse and being conducted in the University Hospital-Newark Emergency Department. The PI is Dr. Ethan Cowan, MD, MS, Professor of Emergency Medicine at NJMS and Associate Director, Treatment & Recovery, Rutgers Addiction Research Center. 

The trial, “Safety and Efficacy of High Dose BUP Induction in Fentanyl Positive Emergency Department Patients” is a Phase 3 clinical trial evaluating high-dose buprenorphine (BUP) (32 mg) induction for individuals experiencing opioid withdrawal. The study aims to determine whether higher-than-standard dosing not only remains safe and tolerable, but also significantly improves short-term engagement in comprehensive addiction treatment. Initial data suggest that the 32mg doses are well tolerated and could speed symptom relief, laying the groundwork for innovations in ED-based OUD care.

The study is actively recruiting now.  

Congratulations Dr. Cowan and team on this important work!

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!

How to engage in a person-centered consent process to facilitate informed decision making about study participation. Research teams will learn how to use an educational resource to understand considerations for ensuring participant consent is informed and voluntarily given, apply strategies for supporting a person-centered consent process for empowered decision making, and identify supplemental resources for increasing comprehension during the consent process.

Can I submit an IRB application before the contract and budget are final?

Study teams are often asked by sponsors or CROs during the feasibility process whether Rutgers requires us to wait until the contract and budget are final before submitting the IRB application. The answer is “No” – we can proceed with IRB review while the contract and budget are being negotiated.

Keep in mind, though, that last-minute changes may need to be made to the consent form. For example, the amount of a patient stipend may be different in the final version of the budget than what you put into the consent form initially.

You may have seen a recent announcement that Greenphire merged with Suvoda earlier this year. This will result in a number of branding changes that will impact our ClinCard program. Although “ClinCard” will continue to be the name on the debit card and virtual card payment methods, the overarching product name will become “Greenphire Patient Payments.”  Study coordinators and study participants will start to notice the branding changes on the portals by next month. 

Please also be reminded that Rutgers study participants must specifically consent to use ClinCard/Greenphire Patient Payments. This can be done by using either a standalone consent form or by inserting template language into the main study consent.

Revisions of these informed consent language templates to reflect the new branding are currently under review with the Rutgers IRB, and should be available on the HRPP website Toolkit under “Consent Addenda” shortly.

We will be updating both the Rutgers ClinCard Participant Portal and the CTO’s ClinCard information portal in the near future as well. Please shoot us an e-mail at clinicaltrials@rbhs.rutgers.edu with any questions.

Competing Studies

Is your department considering taking on a new study that may compete for the same participant population with a study you are already doing? Please consult the CTO before deciding to move forward. Many clinical trial agreements specifically prohibit an investigator from participating in a competing study. We can help figure out whether this applies in your situation and possibly find a solution that works for all parties.

You can find OnCore notes by clicking on the note icon in the top left corner of PC console. If no icon is present, a note has not been created yet. Alternatively, they can be found in Documents/Info -> Archive/Notes.

OnCore notes is updated in real time by the CTO team as progress is made in terms of calendar builds and budget/contract negotiations. All OnCore users should have access to notes.

Please shoot us an e-mail at clinicaltrials@rbhs.rutgers.edu with any questions about specific startup activities or access issues.

The CTO recently launched a new portal to streamline common requests. This portal replaces our old DocuSign request process, and serves as a “one-stop shop” to request access to the various electronic systems we manage (i.e. OnCore, eReg, Advarra University, ClinCard, Deep6, DocuSign, etc.) and to request various services related to these systems (for example, OnCore reports, CAM requests and more.)  We hope this process will be less burdensome for our users and that it will allow us to more efficiently address your needs. Please check it out by clicking here and letting us know what you think!

Clinical Research Pet of the Month

September's clinical research pet of the month is Bailey. Her pet parent is Kelly Saverino, a Clinical Research Coordinator at the NJMS Clinical Research Unit.

Bailey is a 10.5 year old beagle who loves long walks and lots of treats. Her favorite activities include lounging in the sun in the backyard, chasing squirrels, and going on family camping trips.

Congratulations to Kelly and Bailey!

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

We very much welcome your comments and suggestions – please drop us a line with your thoughts at clinicaltrials@rbhs.rutgers.edu.