NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – NCI/DCTD Responsibilities
C. NCI/DCTD Staff Responsibilities
The role of the NCI Division of Cancer Treatment and Diagnosis (DCTD) staff, as described throughout these
Terms and Conditions of Award, is to assist, facilitate, and ensure optimal coordination of NCTN activities. The
NCTN is part of a larger NCI-sponsored clinical trials program that also includes investigational agent
development. The Cancer Therapy Evaluation Program (CTEP) staff has very specific and well-defined
responsibilities for the oversight and review of Network Group clinical trials and for investigational agent
development that meets DCTD/CTEP responsibilities as sponsor of Investigational New Drug Applications (INDs)
and Investigational Device Exemption (IDE) as defined in the Code of Federal Regulations (CFR) 21 Part 312. The
Cancer Imaging Program (CIP) staff has similar responsibilities with respect to INDs for investigational imaging
agents in applicable NCTN trials. The responsibilities of NCI/DCTD staff are described below.
1. Coordination of National Priorities
NCI/DCTD staff is responsible for maintaining a clear set of national priorities for treatment research, based
upon substantial consultation with experts in the field. In selected disease areas, particularly when
spontaneous planning does not occur within the Network Groups, NCI/DCTD staff with support from the
Coordinating Center for Clinical Trials (CCCT) will help in coordinating the organization of Clinical Trials
Planning Meetings under the auspices of the NCI Scientific Steering Committees. In addition, NCI/DCTD
staff may support ad hoc scientific meetings to help achieve consensus on critical clinical problems. These
Clinical Trials Planning meeting and ad hoc meetings will be composed of investigators with established
expertise in the particular field of interest and will consist primarily of extramural scientists. NCI staff will
be responsible for prompt dissemination of the recommendations from these meetings, particularly
regarding statements of research priorities from Clinical Trials Planning meetings, and the Network Groups
will be encouraged to address these priorities.
2. Scientific Resource and Liaison Activities
NCI/DCTD staff serves as both a resource and liaison for Network Groups and their members, as well as the
other key components of the NCTN Program.
2.1 Scientific Resource for NCTN Clinical Investigations
The Lead NCTN Program Director, the Associate Director (AD), CTEP, DCTD and staff of the various CTEP
branches, including the Clinical Investigations Branch (CIB), the Investigational Drug Branch (IDB), the
Regulatory Affairs Branch (RAB), the Pharmaceutical Management Branch (PMB), and the Clinical Trials
Monitoring Branch (CTMB), as well as staff from other DCTD programs, including the Biometric
Research Branch (BRB), the Cancer Imaging Program (CIP), the Radiation Research Program (RRP), and
the Cancer Diagnosis Program (DCP), all serve as resources available to Network Groups for specific
scientific information with respect to treatment regimens, clinical trial design, investigational agent
management, regulatory issues, etc. The NCI/DCTD staff also work closely with the NCI/DCP staff to
coordinate operating processes and procedures for the Network Groups as well as to ensure there is a
high level of integration of complementary research efforts on specific trials.
The NCI DCTD staff listed above will assist the Network Groups, their members, and other key
components of the NCTN Program, as appropriate, in developing information concerning the scientific
basis for specific trials, operational and regulatory issues, and will also be responsible for advising the
Network Groups of the nature and results of relevant trials being carried out nationally or
internationally. CIB and IDB staff will also provide updated information to the Network Groups on the
efficacy and adverse events associated with new investigational agents supplied to Network Group
members under a CTEP-sponsored IND. In addition, CIB staff advises the Groups of potential
agents/interventions that will be relevant to new avenues of cancer therapy.
2.2 Scientific and Administrative Program Directors & Liaison Activities
The Lead NCTN Program Director is the NIH/NCI Program Official responsible for the routine scientific
and programmatic stewardship of all the awards for the NCTN Program and will be named in the award
notice. Co-Program Directors may also be named in the award notice for some of the key components
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