Clinical Research Spotlight: Project Management Office
As part of the UF Health Cancer Center Clinical Research Office, the Project Management Office (PMO) provides a variety of services to support and promote successful Investigator Initiated Trials (IITs) for UFHCC members, from concept development to final result dissemination. By providing these services, the PMO plays a critical role in the startup and execution of these IITs.
The PMO team is committed to engaging with investigators in order to support the ultimate mission of the UF Health Cancer Center via:
- Aiding in development of innovative concepts
- Increasing efficiency of research projects
- Providing administrative support from project development through publication
Below, Project Management Office manager Shannon Alford, MPH, CCRP, gives us the inside scoop on the PMO’s services, goals and opportunities — and shares why YOU should consider using this resource for future clinical research.
WHAT’S THE MOST IMPORTANT THING FOR CANCER CENTER MEMBERS TO KNOW ABOUT THE PROJECT MANAGER OFFICE?
The Project Management Office (PMO) is here to provide investigators who are conducting interventional treatment investigator-initiated trials (IITs) with a full spectrum of services to help get these otherwise complex trials off the ground as seamlessly as possible. Such services include concept refinement, protocol development, interfacing with potential industry partners, regulatory approvals including the Food and Drug Administration (FDA), operational planning, full project management once the trial is open and all the way though to assisting with final result generation and dissemination.
We have an internal slogan of “From Concept to Care,” which really embodies the goal of the PMO office to help investigators translate innovative concepts into meaningful new treatments for people with cancer. We also have started trying to match IIT investigators with grant opportunities to help them fund their projects.
WHEN SHOULD A MEMBER CONSIDER REACHING OUT TO THE PMO AND WHY?
Cancer Center members should reach out to us at any step in their clinical trial development. It can be when they have a concept for an interventional treatment trial, a partial protocol or a full protocol and just need help navigating the next steps. We will meet with the investigator, see where they are in the process and detail out next steps and how we will be involved. The reason they should reach out is that we can assist in all aspects of starting an investigator-initiated treatment trial.
We submit to Office of Clinical Research, we submit to the FDA if needed, submit to Scientific Review and Monitoring Committee and work with Clinical Research Office regulatory team to submit to the Institutional Review Board (IRB). We also handle site activation and opening the study to accrual. Many of the important steps to support IIT study success can be time-consuming and confusing for physician-investigators, who are also so busy with other responsibilities like seeing patients, mentoring and conducting industry trials. We really help to lessen the burden of what the investigator needs to do to open an investigator-initiated clinical trial, which is so rewarding.
ARE THERE FEES ASSOCIATED WITH PMO’S SERVICES?
There are a variety of services we can provide, and our administrative fees can be provided upon request during the budget creation process that happens during our intake process with the Concept Development Group (CDG). There is no fee for our assistance with the CDG process or linking investigators with industry partners. Our office at this time is limited to assisting investigator-initiated interventional treatment trials for Cancer Center members.
WHAT IS/ARE A RECENT SUCCESSFUL INSTANCE WHERE THE PMO HAVE HELPED SUPPORT MEMBER RESEARCH?
We have just recently opened three interventional treatment IITs, with the fourth opening soon. We have also assisted several investigators in applications for funding for their IIT concepts, both industry and grants.
One of these IITs that has been especially rewarding to navigate involves a concept examining two agents in combination to treat any one of several different solid tumor cancers. In order to make the project financially feasible, we needed to reach out to industry to secure drug support for both agents. After many meetings between the investigator and various industry representatives facilitated by the PMO office, both agents were secured free of charge to be used in the trial, each from a different company. The investigators were also able to obtain funds to fully cover the project costs. In the process of getting this study open, there were many different touch points with both industry sponsors — a balancing act between rights and responsibilities to be negotiated within each contract, which the PMO office navigated on the investigator’s behalf.
The PMO office also helped draft the protocol from the Scientific Review and Monitoring Committee (SRMC) pre-review form, submitted the FDA and Investigational New Drug (IND), drafted study manuals, created the electronic data capture, developed and provided staff and coordinator training and served as a mediator between the companies to ensure both accepted the final protocol. As the study progresses, our office will also confirm eligibility of subjects, take care of adverse event reporting, conduct study team meetings and ensure reviews and reports to the IRB, FDA, Data Integrity and Safety Committee, and sponsors are completed. These are the tasks that can be very time-consuming and effortful for a physician-investigator, especially with two different sponsors, which is why our office is here to help alleviate some of the confusion and streamline some of the complex processes for them.
Once the study has successfully completed enrollment, PMO will assist with facilitating data analysis and result dissemination. Our office works closely with Clinical Research Office (CRO) coordinators, auditors and monitors to ensure all regulatory policies are followed and the study maintains compliance with FDA and Good Clinical Practice (GCP) guidelines.
WHAT IS THE INVESTIGATOR-INITIATED TRIAL CONCEPT DEVELOPMENT GROUP AND WHEN WOULD MEMBERS NEED TO SEEK ASSISTANCE?
The ITT Concept Development Group is a rapid review committee that all potential interventional treatment IIT concepts, or those proposing use of CRO resources, must go through prior to seeking funding. The aim of this comprehensive review is to improve the feasibility, scientific merit and ultimate success in completing IITs, shorten the time frame from concept approval to study activation (by anticipating and proactively addressing concerns that otherwise may come up later at SRMC or IRB), and maximize staff and investigator effort in trial execution. Our office has a form (SRMC Pre-Review form) we use to guide the concept through this process which includes statistical, scientific, and feasibility review and consultation. The CDG will also result in an approved budget that can be used to seek funding, knowing that all costs (even those that may not be anticipated initially by the Principal Investigator) are budgeted for. On our website, we have a link to the SRMC Pre-Review form for investigators to fill in or get started, and instructions on how to submit. Our office is also active in assisting with the completion of this form.
WHAT ELSE ABOUT THE PMO DO YOU WANT TO HIGHLIGHT FOR MEMBERS — A SPECIFIC SERVICE? ANY KEY TAKEAWAYS OR COMMON MISCONCEPTIONS?
We want Cancer Center members to know we are here to help with the heavy lifting associated with interventional treatment IITs, and we have an enthusiastic team of 3 project managers with clinical research expertise, specifically at UF, ready to assist with every step. We can take out the intimidation factor that some investigators have about opening interventional treatment IITs by making it a simpler process. We are always willing to answer additional questions about what we do and the scope of our services. Investigators can email myself firstname.lastname@example.org or the PMO group PMO@cancer.ufl.edu. Investigators can also go to our website for more information:
WHAT DO YOU ENJOY ABOUT YOUR ROLE AS THE MANAGER OF THE PROJECT MANAGER OFFICE?
There are many aspects of my role here at the Cancer Center that I love, but what I enjoy most about my position is interacting with investigators and doing whatever I can do to turn their concept into a successful clinical trial. It is so rewarding to know that I am helping make an IIT concept a reality for an investigator. Also, what is even more rewarding is knowing that in some small way, I am having an impact on the care cancer patients receive and contributing to the larger goal of improving cancer treatments and survivorship.