Roswell Park Cancer Institute has opened one of the first Clinical Research Centers in the nation that focuses specifically on the development of new cancer treatments. The Center will provide more treatment options for patients through clinical research studies, and will make it possible to expand RPCI’s program of Phase I studies, which represent the first step toward FDA approval.
Housed in the Roswell Park hospital, the Clinical Research Center is designed to provide the highest level of patient safety and to quickly generate precise data on potential new treatments. These capabilities will help attract studies sponsored by the National Cancer Institute and sponsoring pharmaceutical companies, while supporting studies launched by RPCI’s own scientists.
Built with a $2 million gift from an anonymous benefactor and additional funds from RPCI, the Center features:
- Seven inpatient beds and ten outpatient chairs
- When fully staffed, 22 full-time Research Nurses, plus Hospital Clinical Assistants and Clinical Support Assistants
- A dedicated Investigational Drug Service staffed by Clinical Pharmacists and Pharmacy Technicians specializing in the drugs and agents used in clinical studies. The pharmacy dispenses all drugs used in clinical research studies for patients being treated in the Center.
- A dedicated Specimen Processing Center, with dedicated Lab Technicians and facilities for processing and storing biological samples needed for studies
- Computers in every room, so Research Nurses can record data in a timely manner
- A room equipped for video conferencing, so members of the clinical and research team can confer with study sponsors and colleagues at other institutions who are participating in RPCI clinical research studies
- A conference room for patient/family education
Before the Center opened, RPCI patients enrolled in clinical research studies received treatment either in the Chemotherapy Infusion Clinic or in regular hospital units. In the Center they will receive care from nurses who are specially educated to help patients manage the side effects of administered investigational medications, as well as implement all of the study data requirements.
While other medical research institutions have General Research Centers (GRCs), which are funded by the National Institutes of Health (NIH), GRCs are designed to conduct research on many types of diseases and are required by the NIH to enroll no more than 49% of patients with any one disease. That rule produces a juggling act to accommodate all the patients participating in oncology clinical research studies, notes Joyce Yasko, PhD, RN, former Vice President, Clinical Research Administration and Services.
The new Center adds even more muscle to a historically strong clinical research program. Among other milestones, Roswell Park participated in clinical studies that helped speed FDA approval of Gleevec®, now a first-line therapy for chronic myeloid leukemia (CML).
Alex Adjei, MD, PhD, Senior Vice President for Clinical Research, Chair of the Department of Medicine, and the Katherine Anne Gioia Chair in Cancer Medicine, says that the opening of the Center, combined with the recruitment of top-notch scientists and the high quality of ongoing research at Roswell Park, means “we’re going to have promising new drugs available here that we didn’t have in the past.”