NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 1: Overview of NCTN Program Section I – Description of Essential Features & Key Components
7.5.1 NCI Clinical Trials and Translational Research Advisory Committee (CTAC)
The NCI Clinical Trials and Translational Research Advisory Committee (CTAC) is an external
oversight committee, governed by the provisions of the Federal Advisory Committee Act, that
advises the NCI Director on the NCI-supported national clinical and translational research
enterprises, including both intramural and extramural research. Committee members include
leading authorities in clinical trials and translational research. The CCCT Director serves as the
Executive Secretary for CTAC and the CCCT staff facilitates operations. General information on
CTAC is available at: http://deainfo.nci.nih.gov/advisory/ctac/ctac.htm.
The CTAC Strategic Planning Subcommittee for the NCTN evaluates the clinical trial portfolio
across the entire NCTN and provides recommendations to CTAC regarding the
evaluation/prioritization decisions of the NCI Scientific Steering Committees (e.g., NCI diseasespecific
Steering Committees, Clinical Imaging Steering Committee) and reviews the overall trial
portfolio for gaps and balance among the different disease areas and modalities.
7.5.2 NCI Scientific Steering Committees (SSCs)
The NCI Scientific Steering Committees strive to enhance the NCI’s entire clinical trials enterprise
through implementation of prioritization and scientific quality initiatives under the purview of
the NCI Clinical Trials and Translational Research Advisory Committee (CTAC)
As part of that process, NCI disease-specific Scientific Steering Committees (SSCs)
evaluate/prioritize phase 3 and large, early-phase clinical trials conducted by the NCTN Program.
A Clinical Imaging Steering Committee evaluates/prioritizes large primary advanced imaging
studies. The NCI SSCs and Clinical Imaging Steering Committee are composed of leading cancer
experts and advocates from outside the Institute, NCTN Network Group representatives, and NCI
senior investigators who meet regularly to:
� increase the transparency and openness of the trial design and prioritization process;
� enhance patient advocate and community oncologist involvement in clinical trial design
and prioritization; and
� convene Clinical Trials Meetings to identify critical questions, unmet needs, and
prioritize key strategies.
These Committees may also establish one or more Task Forces and/or Working Groups that
focus on specific sub-categories of disease or other scientific areas of interest. General
information on the NCI Steering Committees is available at:
http://transformingtrials.cancer.gov/steering/overview.
7.5.3 NCI Clinical and Translational Research Operations Committee (CTROC)
The Clinical and Translational Research Operations Committee (CTROC), an internal NCI advisory
committee composed of representatives from NCI Divisions, Offices, and Centers involved in
NCI-supported clinical trials and translational research, provides strategic oversight for NCI
clinical trials and translational research programs and infrastructures, including informatics. The
Committee reviews and prioritizes clinical trials and translational research programs proposed
by Divisions, Centers, and Offices to coordinate efforts Institute-wide. CTROC also oversees and
approves applications under the Biomarker, Imaging, and Quality of Life Studies Funding
Program (BIQSFP) to support essential biomarker, imaging, and quality of life studies as well as
Cost-Effectiveness Analysis (CEA) proposals which are associated with Network Group clinical
trial concepts approved for conduct under the NCTN Program that are eligible for BIQSFP
funding. Information on the BIQSFP is available at: http://biqsfp.cancer.gov/.
Page 20 of 241