By Bill Coleman,2014-05-28 14:36
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     The National Comprehensive Cancer Network (NCCN) is a nonprofit alliance of twenty (20) of the world??s leading cancer centers. NCCN member institutions are committed to conducting high-quality phase I through IV oncology clinical trials. NCCN is dedicated to supporting the research enterprises of its member institutions and, as such, has developed an Oncology Research Program (ORP) with an infrastructure that links industry-supported research to investigators throughout its network.

     We seek to reduce cancer-related deaths and improve the quality of life for patients by advancing cancer therapies through clinical trials. We believe that building centralized clinical trials infrastructure, in which sponsors have access to premier investigators, will help to provide patients with state-of-the-art clinical trials.


     To play an instrumental role in furthering the science of oncology through the conduct of translational and clinical research at NCCN member institutions and to quickly transfer knowledge gained through research to the practice setting.

     The NCCN ORP is organized to facilitate the implementation and conduct of cancer trials at NCCN member institutions using two unique models; the research grant model and the

     industry-directed research model. The research grant model is

     available to all pharmaceutical/biotechnology companies. The industry-directed research model is available only to those pharmaceutical/biotechnology companies who are members of the NCCN Industry Advisory Roundtable. The NCCN Investigator Steering Committee, comprising senior research physicians appointed by each member institution, sets policies and standards for the program. ??The grant obtained through the NCCN allowed me to develop and fund original research in the management of patients with advanced cervical carcinoma. The integration of novel chemotherapeutic agents to our standard treatments is an area of investigation that continues to show promising results.Through continuing collaboration and support of scientific investigators, the NCCN provides opportunities for growth and development of innovative cancer research.?? Pedro T. Ramirez, MD The

University of Texas M.D. Anderson Cancer Center


     The NCCN ORP has received millions of dollars in research grants from major pharmaceutical companies to support investigator-initiated trials which explore new avenues of clinical investigation that answer important scientific questions. Studies evaluate innovative combinations and sequencing regimens of drugs, mechanisms of action of specific agents, drug resistance, or are directed toward exploring extended uses for specific agents. The NCCN ORP organizes expert Project Advisory Teams to develop Requests for Proposals (RFPs). Scientific Review Committees are organized to provide scientific peer review and approval of study concepts, review and approval of study budgets, and to provide advice and guidance to investigators as needed and at annual Investigator Meetings. Multi-institutional trials are encouraged to foster interactive sharing of knowledge and expertise and to utilize the combined clinical strengths of member investigators and institutions. The NCCN ORP is responsible for contracting, ensuring general regulatory compliance, disbursing funds, monitoring accrual, eligibility and evaluability of study participants, and coordinating annual investigator meetings. Investigators receiving grants are encouraged to present study results at medical meetings and required to develop manuscripts for submission to peer-reviewed journals, thus disseminating knowledge gained through studies to practicing oncologists.

     ??Proposals from NCCN institutions are critically reviewed. As a participant in this review process, I was impressed with the quality of the applications.?? Neal J. Meropol, MD Fox Chase Cancer Center

     This model has proven very successful and mutually beneficial for NCCN??s industry partners as well as for NCCN investigators and member institutions.


     A variety of clinical trial services are available to members of the NCCN Industry Advisory Roundtable for industry-sponsored research. Services include: Expert Consultants and Panels Leading NCCN clinicians and investigators evaluate promising new chemical entities or biological agents. Our experts ?C the oncology community??s ??thought leaders?? ?C can work with industry to design scientifically valid clinical trials. They can serve as consultants or panelists to provide advice during any stage of protocol development, including post-approval activities. Rapid Site Identification The Investigator Steering Committee oversees the NCCN ORP. Its members serve as Principal Investigators (PIs) at each member institution. Our PIs have the ability to rapidly facilitate the identification of interested and qualified investigators for clinical trials at their institutions. The NCCN ORP

    can also conduct feasibility surveys to qualify sites for studies. ??There is a growing crisis facing institutions that conduct clinical trials, particularly in the area of investigator initiated translational research projects. Trials are increasing in complexity because there is the need to link efficacy data and biologic correlates. Unfortunately, as treatment opportunities and technology advances expand, adequate funding resources are diminishing, most notably funding from the government. It is more important than ever that we partner with others, including industry, if we are going to embrace these treatment and technology innovations and integrate such in clinical trial design. A recent NCCN peer-reviewed grant to support an esophagus project at Northwestern University is an example of an alternative funding source that made this project possible.?? Al B. Benson, III, MD Robert H. Lurie Comprehensive Cancer Center of Northwestern University

     Multiple sites can be identified for trial participation in as few as 10 business days.

     Broad Access to Academic and Community Physicians With more than 2,000 investigators at our member institutions, the NCCN ORP provides access to academic investigators and their diverse patient populations. Our investigator database enables us to perform real-time searches for professional profiles of physicians according to specialty, research interests, and specific areas of expertise. Access to Patients An estimated 150,000 new cancer patients are treated annually at NCCN member institutions. Expedited Site Initiation Our services expedite the start-up of a clinical trial, which can mean earlier patient enrollment and study completion. This translates into more rapid approval and availability of promising new treatments. Site Initiation services include: ??As a scientific advisor on the Angiogenesis Panel, I found working with the NCCN to be an effective way to bring together national experts to develop, implement and review clinical trials of new agents.The meetings were well-planned, robust, focused, and balanced - an important vehicle to translate discoveries from the laboratory to the bedside.?? Steven Brem, MD H. Lee Moffitt Cancer Center & Research Institute at the University of South Florida N Standard Contract N Master Confidentiality Agreement N Standard Budget Development N Standard IRB Forms N Study Placement through the Investigator Steering Committee


     NCCN member institutions are in a position to collectively impact the incidence, morbidity, and mortality of cancer by using their combined strengths in cancer research. Working with major pharmaceutical and biotechnology organizations, we identify investigators and initiate trials in all study phases. We have expertise

    in all areas of oncology including solid tumors, hematologic malignancies, and supportive care areas. ??We were so excited to have an opportunity to conduct the Phase II study of Celecoxib in patients with iodine-refractory metastatic differentiated thyroid carcinoma, the first study of its kind completed in the last three decades. Sponsorship from the NCCN for our study was extremely valuable, as it made it possible to conduct such a worthwhile study in patients with uncommon cancers. Experience gained from this study has paved the road for a series of several Phase II thyroid cancer clinical trials at Ohio State University.?? Manisha Shah, MD Arthur G. James Cancer Hospital & Richard J. Solove Research Institute at The Ohio State University

     CONTACT US To learn how we can help you develop and evaluate your promising new pharmaceutical or biological agent, or how to join the NCCN Industry Advisory Roundtable, contact the NCCN ORP at 215.690.0230 or OncologyResearch@nccn.org

     500 Old York Road Suite 250 Jenkintown, PA 19046 215.690.0300 Fax: 215.690.0280

     Fred Hutchinson Cancer Research Center/ Seattle Cancer Care Alliance Dana-Farber/Partners CancerCare Robert H. Lurie Comprehensive Cancer Center of Northwestern U. Roswell Park Cancer Institute Memorial Sloan-Kettering Cancer Center Fox Chase Cancer Center

     UCSF Comprehensive Cancer Center Stanford Hospital & Clinics

     Huntsman Cancer Institute at the U. of Utah

     UNMC Eppley Cancer Center at The Nebraska Medical Center

     U. of Michigan Comprehensive Cancer Center Siteman Cancer Center at Barnes-Jewish Hospital and Washington U. School of Medicine

     The Sidney Kimmel Comprehensive Cancer Arthur G. James Cancer Center at Johns Hopkins Hospital & Richard J. Solove Research Institute at The Ohio State U. Duke Comprehensive Cancer Center

     City of Hope Cancer Center

     St. Jude Children??s Research Hospital/ U. of Tennessee Cancer Institute

     The U. of Texas M. D. Anderson Cancer Center

     U. of Alabama at Birmingham Comprehensive Cancer Center

     H. Lee Moffitt Cancer Center & Research Institute at the U. of South Florida

     The National Comprehensive Cancer Network (NCCN), a not-for-profit alliance of 20 of the world??s leading cancer centers, is dedicated to improving the quality and effectiveness of care provided to patients with cancer.Through the leadership and expertise of clinical professionals at NCCN member institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. As the arbiter of high-quality cancer care, NCCN promotes the importance of continuous quality improvement and

    recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers.The primary goal of all NCCN initiatives is to improve the quality, effectiveness, and efficiency of oncology practice so patients can live better lives. For more information, visit www.nccn.org.

     2006 NCCN All rights reserved




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