By Diane Paul, MS, RN, Vice President, NCCN Oncology Research Program
The NCCN Oncology Research Program (ORP) collaborates with pharmaceutical companies to obtain funding to support investigator-initiated trials at NCCN Member Institutions for approved oncology drugs as well as those in early to late phase development. The ultimate goal of the program is to improve the quality of life for patients and to reduce cancer-related deaths by advancing cancer therapies through research. Since its establishment in 1999, the NCCN ORP has successfully raised more than $26 million dollars to support research at its Member Institutions.
Just recently, the NCCN ORP received a $2.1 million research grant from Pfizer to develop a program to scientifically evaluate and define the clinical effectiveness of axitinib in various tumor types. The first phase of the program will involve the establishment of an NCCN Axitinib Request for Proposals Development Team to evaluate existing data and to discuss and define the types of studies necessary to further characterize the clinical effectiveness of axitinib.
Studies made possible through NCCN ORP funding evaluate innovative combinations and sequencing regimens of drugs, mechanisms of action of specific agents, drug resistance, and extended uses for specific agents. Additionally, the NCCN ORP organizes scientific advisory boards to advise companies on their drug development strategies.
The NCCN ORP collaborates with pharmaceutical companies through the use of two separate and unique research models: the Research Grant Model supports investigator- initiated research through a process of announcing a Request for Proposals and organizing expert scientific committees to support the peer review of proposals, or the Drug Development Research Grant Model that supports the development of a specific protocol in collaboration with industry. For both models, the NCCN ORP provides services for the projects from organizing scientific committees, contracting with sites, overseeing the regulatory aspects of the trials, ensuring serious adverse event reporting, fund disbursement, data monitoring, and the review of final manuscripts for publication.
A new initiative of the NCCN ORP in 2010 has been the establishment of the NCCN Specialized Imaging Research Consortium (SIRC). The mission of the SIRC is to advance the treatment of patients with cancer through the clinical application of specialized imaging technologies by performing high-quality clinical trials of emerging therapeutics integrated with evidence-based research to guide the use of advanced imaging in clinical cancer care.
In particular, the SIRC aims to:
NCCN’s ORP recognizes the need for multi-institutional trials in order to complete studies faster and has built an infrastructure in the SIRC to support them. An advisory group made up of medical oncologists and disease-specific specialized imaging experts serve as a resource to industry in their drug development strategies.
NCCN Member Institutions see a diverse patient population and all possess high-quality basic science laboratories and specialized imaging capabilities. Bringing sites together in the context of the SIRC has resulted in a consortium that is much more than the sum of its parts and enhances NCCN’s ability to evaluate and guide the use of imaging in clinical cancer care.