Oct 25, 2012
Following NCI’s announcement of six contract awards available through the new National Clinical Trials Network (NCTN), ASCO and the Institute of Medicine (IOM) will host a workshop on the continuing efforts to reorganize the National Clinical Trials Cooperative Groups. “The workshop provides an opportunity for the research community to discuss and strategize about how we can work together to improve this system for our patients and advance cancer prevention, detection, and treatment for future generations,” commented Dr. Monica Bertagnolli (Chief, Division of Surgical Oncology, Brigham and Women’s Hospital; Group Chair, Alliance for Clinical Trials in Oncology), who is chairing the IOM-ASCO workshop planning committee.
The workshop, scheduled for February 11-12, 2013, will be the second of its kind. In March 2011, IOM’s National Cancer Policy Forum and ASCO brought together clinical trials stakeholders, ASCO members, and federal agency representatives to discuss how to increase the efficiency and productivity of the clinical trials system, including efforts to consolidate the existing Cooperative Groups, public-private collaboration, funding, and ensuring broad involvement of patients and health care providers. The 2011 agenda was focused on strategies to implement the IOM’s 2010 consensus report A National Cancer Clinical Trials System for the 21st Century. This second workshop will build upon these goals and is slated to address funding challenges, prioritization of research, effective partnerships, and regulatory challenges.
Under the NCTN, four adult groups and one pediatric group will be created, according to the NCI document, “National Clinical Trials Network Program Guidelines,” published July 23, 2012. These groups will have the opportunity to apply for two awards: 1) the Network Group Operations Centers, and 2) the Network Group Statistics and Data Management Centers. Under these two categories, only five awards will be given—and so the existing National Clinical Trials Cooperative Groups have already begun efforts to consolidate.
Reorganized entities must submit applications to the NCTN program by January 15, 2013. If approved, the earliest funding start date is March 1, 2014.
In preparation for the workshop, IOM has formed an independent planning committee to develop an agenda and identify speakers. The planning committee includes several ASCO leaders, although they are strictly involved as informed and active stakeholders in the NCTN and not representing an ASCO position. Past ASCO Board of Directors member Monica M. Bertagnolli, MD, serves as planning committee Chair. The planning committee also includes past ASCO President George W. Sledge, MD, current ASCO Board of Directors member Robin Zon, MD, FACP, as well as ASCO members Renzo Canetta, MD; Michaele C. Christian, MD; Michael A. Caligiuri, MD; James H. Doroshow, MD; Amy P. Aber¬nethy, MD; Gregory H. Reaman, MD; and Ralph R. Weichselbaum, MD.
ASCO’s role in the workshop will be to help shape the agenda and to provide funding to make the workshop hap-pen. The Society’s goal is continued transparency and an opportunity for dialogue and public engagement in the reorganization of the national clinical trials system.
The NCTN is being designed to replace and reinvigorate the 50-year-old National Clinical Trials Cooperative Group program. The contract awards are expected to comprise a total of $160.5 million in fiscal year 2014. Furthermore, an NCI presentation in November 2011 to the NCI Board of Scientific Advisors discussed an additional $25.6 million annually for increased payments to “high performance” sites and for studies involving biomarkers, imaging, and quality of life.
For information on the upcoming workshop, visit iom.edu; for information on revitalization efforts, visit asco.org/GroupReorganization; for investigator resources, visit ctep.cancer.gov/InvestigatorResources.
The workshop, scheduled for February 11-12, 2013, will be the second of its kind. In March 2011, IOM’s National Cancer Policy Forum and ASCO brought together clinical trials stakeholders, ASCO members, and federal agency representatives to discuss how to increase the efficiency and productivity of the clinical trials system, including efforts to consolidate the existing Cooperative Groups, public-private collaboration, funding, and ensuring broad involvement of patients and health care providers. The 2011 agenda was focused on strategies to implement the IOM’s 2010 consensus report A National Cancer Clinical Trials System for the 21st Century. This second workshop will build upon these goals and is slated to address funding challenges, prioritization of research, effective partnerships, and regulatory challenges.
Under the NCTN, four adult groups and one pediatric group will be created, according to the NCI document, “National Clinical Trials Network Program Guidelines,” published July 23, 2012. These groups will have the opportunity to apply for two awards: 1) the Network Group Operations Centers, and 2) the Network Group Statistics and Data Management Centers. Under these two categories, only five awards will be given—and so the existing National Clinical Trials Cooperative Groups have already begun efforts to consolidate. Reorganized entities must submit applications to the NCTN program by January 15, 2013. If approved, the earliest funding start date is March 1, 2014.
In preparation for the workshop, IOM has formed an independent planning committee to develop an agenda and identify speakers. The planning committee includes several ASCO leaders, although they are strictly involved as informed and active stakeholders in the NCTN and not representing an ASCO position. Past ASCO Board of Directors member Monica M. Bertagnolli, MD, serves as planning committee Chair. The planning committee also includes past ASCO President George W. Sledge, MD, current ASCO Board of Directors member Robin Zon, MD, FACP, as well as ASCO members Renzo Canetta, MD; Michaele C. Christian, MD; Michael A. Caligiuri, MD; James H. Doroshow, MD; Amy P. Aber¬nethy, MD; Gregory H. Reaman, MD; and Ralph R. Weichselbaum, MD.
ASCO’s role in the workshop will be to help shape the agenda and to provide funding to make the workshop hap-pen. The Society’s goal is continued transparency and an opportunity for dialogue and public engagement in the reorganization of the national clinical trials system.
The NCTN is being designed to replace and reinvigorate the 50-year-old National Clinical Trials Cooperative Group program. The contract awards are expected to comprise a total of $160.5 million in fiscal year 2014. Furthermore, an NCI presentation in November 2011 to the NCI Board of Scientific Advisors discussed an additional $25.6 million annually for increased payments to “high performance” sites and for studies involving biomarkers, imaging, and quality of life.
For information on the upcoming workshop, visit iom.edu; for information on revitalization efforts, visit asco.org/GroupReorganization; for investigator resources, visit ctep.cancer.gov/InvestigatorResources.