trials network to accelerate the development and translation of innovative cancer therapies for Connecticut residents; and co-investing in shared core resources. Refining and Creating Research Facilities There is no doubt that the former gcrc, which is now known as the Hospital Research Unit (hru), is crucial to furthering Yale’s clinical research enterprise. This facility, located at Yale-New Haven Hospital, plays a central role in advancing clinical research at Yale by ensuring optimal patient care and safety for moderate- to high-risk studies. Well known for its skilled nursing staff, the hru supports many nih-sponsored intensive research studies. It is in great demand by a large contingent of well-funded investigators from numerous departments conducting high-impact clinical studies. Although the gcrc had many elements that functioned well, one of YCCI’s tasks has been to examine the efficiency with which clinical research is conducted. A targeted review of the hru by external advisors from other ctsa sites resulted in an in-depth efficiency evaluation by Carpedia International, a consulting firm with deep expertise in evaluating similar facilities. Carpedia worked directly with unit managers to address inefficiencies and reduce labor expenses. The project was challenging because it required change management at all levels, but the result is a “leaner and meaner” inpatient research unit poised to continue Yale’s longstanding track record of high-quality nih-funded patient-based research.
A team meets monthly to devise innovative ways of reducing the time it takes to finalize contracts in order to get studies off the ground more quickly. From l to r: Tanisha Asbery, senior grant and contract administration (GCA) Manager; Michael Glasgow, executive director, GCA; Donald Deyo, director, clinical trials, GCA; Henry Durivage, PharmD, associate director for clinical trials, YCCI
The hru offers investigators core laboratory services and a bionutrition unit, which played an important role along with its expert nursing staff in the research of both Shulman and O’Malley. Shulman relied for his metabolic research on diabetes on the hru for overnight studies, during which he employed the bionutrition unit to control food intake and the core lab to analyze blood samples. These services also helped O’Malley implement studies on EtG. During patients’ overnight stays in the hru, they consume menus devised to minimize variability in alcohol absorption, while the core lab is used to measure levels of EtG both during and after hospitalization. O’Malley has also used the bionutrition unit in studies examining whether food deprivation undermines a smoker’s ability to resist smoking. Such studies would not be feasible without the ability to carefully monitor patients. While the hru is focused on complex inpatient studies, YCCI also recognized the need for a facility for investigators conducting low-risk outpatient studies. To accommodate this need, YCCI opened the Church Street Research Unit (csru), which is located on the medical campus near the ycci.yale.edu
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