NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – Network Group Ops Centers
B. Specific Terms and Conditions of Award for the Key Components of the NCTN Program
1. Specific Awardee Rights & Responsibilities - Network Group Operations Centers
Throughout these Terms and Conditions of Award, “Network Group Operations Center” refers to the
organizational structure which is composed of the key personnel (including the scientific and administrative
leaders of the Center and its scientific research and administrative committees) and the member
institutions/sites (including the institution/site physicians and clinical research associates), responsible for
implementing clinical trials and collaborating on research goals of the NCTN Program through the Network
Group Operations Center. In addition, throughout these Terms and Conditions of Award, “Network Group
Operations Center,” refers to all of its member institutions/sites no matter how the membership is defined
by a particular Network Group Operations Center.
1.1 Clinical Trial Development Program
1.1.1 Overall Research Strategy
It is the responsibility of the Network Group Operations Center to develop and articulate an
overall research strategy for the Network Group which reflects an integrated scientific approach
both within and across specified disease areas, addresses important unmet clinical needs and
national research goals, includes disease areas appropriate and beneficial to the NCTN, and
within the confines of ethical constraints applicable to early and late phase clinical trials for
oncology patients, includes novel or improved ways and/or methods to enhance the Network
Group’s research strategy and the goals of the entire NCTN.
1.1.2 Scientific Research and Administrative Committees
The Network Group Operations Center is responsible for establishing scientific research
committees and administrative committees and developing a process for the selection of
leadership for these committees. The Network Group Operations Center should ensure that
committees include appropriate representation from the various stakeholders involved in cancer
clinical trial research including a range of scientific and clinical experts and patient advocates.
The Network Group Operations Center is responsible for establishing clear operating principles
and procedures for committees and facilitating their operations by arranging meetings and
establishing and maintaining electronic communication tools.
Scientific research committees are defined as committees that function primarily to develop and
oversee the conduct of clinical trials and studies within a defined research strategy (e.g., disease
committee such as a breast committee that conducts trials in breast cancer, other scientific
committees such as an experimental therapeutics committee or a correlative science
committee). Administrative Committees are defined as committees that provide essential core
service functions to help effect other aspects of the Network Group’s research strategy (e.g.,
Patient Advocacy, Clinical Research Associates, Auditing, Pathology, Surgery).
Correlative science studies, especially integral and integrated studies, are increasingly central to
the interpretation of clinical trials data, particularly for studies of molecularly targeted agents.
Scientific research committees play a key role in the development and conduct of correlative
science studies associated with Network Group protocols. Funding for integrated and integral
correlative science studies is not provided by the NCTN award (except in exceptional
circumstances via an administrative supplement by NCI/DCTD for a specific trial) but may be
applied for via BIQSFP funding for phase 3 and randomized phase 2 trials. Other sources of
funding may be sought for correlative science studies that are not eligible for BIQSFP funding
(e.g., other NCI and NIH grant funding, industry funding).
Organizational Structure: The Network Group Operations Center is responsible for the
Constitution and By-laws for the Network Group. The Constitution and By-laws should define
Page 36 of 241