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Establishing Hematology Clinical Trial Hubs within the City of Hope Community and Affiliate Network

Dr. Siddiqi

Tanya Siddiqi


City of Hope National Medical Center

Project Term: October 1, 2022 - September 30, 2027

City of Hope (COH) has embarked on a strategic initiative to optimize our clinical network and increase research capacity at our Community and Affiliate Network (CAN) sites in Southern California. I would like to spearhead this endeavor for the Hematology program at our new Irvine campus in Orange county, which is set to open in August 2022. We are employing a hub-and-spokes model, in which the Duarte main campus is the main research center, with 3-5 multi-disciplinary CAN sites ultimately designated as research hubs. These CAN sites (hubs) will serve geographically proximal practice sites (spokes), which will refer patients for treatment on clinical trials at either the CAN site itself or at the main Duarte campus. Following a 6-month pilot for optimizing staffing, investigational pharmacy setup, specimen and data collection in Irvine, an additional CAN site will be initiated each year over a 5-year period to allow a wider area of Southern California residents to have access to high quality and impactful clinical trials in Hematology. Our ultimate goal is to accrue 20-50 patients per year from the community, depending on the number of sites activated each year.

Lay Abstract

The COH Comprehensive Cancer Center main campus in Duarte, California has a catchment area of 9,365 square miles, including Los Angeles, Orange, Ventura, Riverside, and San Bernardino counties serving a multi-racial, multi-ethnic community of 17 million people, including those living in urban, suburban, and rural areas. Many of these areas have significant economic, educational, and cancer disparities. To provide better access to state-of-the-art cancer care to all, COH has established numerous CAN sites. All sites share an electronic medical record system. With a population of 3 million, Orange County is the 2nd most populous county in CA and contains a diverse socioeconomic and ethnic population. Although there are some major medical centers in Orange County, there is no wealth of clinical trials with novel therapies to offer to hematology patients there. Repeated 1-2 hour travel each way for trials north to COH main campus or south to San Diego can be prohibitive for many patients. The new COH Irvine campus will be a full-service outpatient cancer center offering hematology/oncology specialist physician care. We will offer clinical trials to the various CAN sites. Our goal is that most of the trial activity will occur at the CAN sites. However, we will also refer patients from our CANs to the Duarte and Irvine COH campuses for therapies that cannot be implemented safely in community sites, for instance cellular therapies which are COH areas of excellence. For trials in these areas conducted in Duarte only, consenting, screening and follow-up could take place at the CAN site to save time and expense for patients. We plan to use IMPACT funding to hire clinical research staff, to develop and implement an electronic platform for ease of consenting and enrollment/screening of patients, to establish the investigational drug pharmacy, to navigate trial patients efficiently through the research processes, and to streamline data entry/analysis. The infusion room nurses will be trained so that all appropriate IRB approved study testing and procedures can be done correctly at the CAN sites. All IRB and regulatory/legal processes will be housed at the Duarte main campus. Our trial discussions within the disease teams/divisions will occur as part of the Duarte main campus weekly research meetings to ensure safe and correct conduct of these trials.

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