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LUNCH WITH LAURA Clinical Trial Streamlining Initiatives

The University of Miami (UM) conducts more clinical research than any other institution in South Florida. To ensure UM remains on the cutting edge of translating research breakthroughs into more effective treatments, a number of initiatives are underway to make the clinical trial process as efficient and streamlined as possible.

ORA Reorganization

Managing the negotiation of clinical trial agreements, in addition to other agreements, can be challenging. This is especially true when other non-clinical trial agreements (like some from foundations) have deadlines which can delay the negotiation of clinical trial agreements that do not have hard deadlines. To address this, ORA is creating a contracting team that is dedicated to clinical research agreements. Currently, this team (lead by Stewart MacIntyre, Director, Pre-Award) handles foundation and industry agreements in addition to clinical trials. Early in the new year, these agreements will transition to our other contracting team lead by Karen Hurdle, Director, Pre-Award. This will leave us with a Clinical Research Contracts Team and a Non-Clinical Research Contracts Team. ORA is currently working on the transition plan to minimize the impact to the community and more information will be coming soon.

ONENESS Initiative

Earlier this year, Jackson Health System (JHS) and the University of Miami kicked off the ONENESS in Research initiative with a joint mission:

One aspect of our joint mission is to advance research through a collaborative effort, built on a shared foundation of diverse and unique patient data and resources integral to the broader missions of UHealth and JHS. Together, as leading academic teaching hospitals and as a national model for public-private partnership, we can accelerate the discovery and delivery of groundbreaking findings to both foster industry engagement and improve the health and welfare of South Florida and beyond.

Five separate working groups have been established to realize this mission. The first working group lead by Dr. Carl Schulman and myself representing UM and Katuska Barbery representing JHS is focused on evaluating the end-to-end clinical trial process (up to activation) to identify and eliminate redundancies, implement parallel processing, eliminating unnecessary handoffs and using metrics to evaluate success. We have engaged with Dr. Howard Gitlow, Professor of Management Science at the Miami Herbert Business School to evaluate and analyze and facilitate the change necessary to streamline our processes. Our goal is to drastically reduce turnaround times which allow us to enroll patients earlier, increase revenue and improve our combined competitiveness.

Please join me on Thursday, December 9th at 12:00 p.m. to discuss this topic further, I would love to hear from you!

Registration is through ULearn.  


Letter from Laura

Lunch wiith Laura is a monthly newsletter and discussion session with me, Laura Kozma, Associate Vice President for Research Administration. There will be new focus each month, including hot topics in research administration, new and significant policies, and changes in the Office of Research Administration (ORA).

The newsletter will be distributed to the University of Miami community and will also be available online. Each newsletter will briefly discuss key points about the monthly focus, including available resources. 
The discussion session, Lunch with Laura, will be held shortly after the newsletter is sent out. All are welcome to come and discuss the monthly focus and ask questions. I look forward to having an opportunity to discuss your concerns and questions in depth. My goal is to make this an opportunity for you and one for me as I can better understand your struggles and challenges. You may submit questions in advance to allow us to engage in a lively discussion.  
Please register for the the Lunch with Laura sessions in ULearn.