NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – Joint Responsibilities
advance for general advice and guidance regarding whether the advantages of international collaboration
will outweigh the expected resource costs.
Network Group Operations Centers are required to have a binding collaborative agreement in place with
the international clinical trial organization that addresses the major components of clinical trial conduct by
the international organization to ensure that the conduct is consistent with all appropriate federal and
other appropriate regulations for the clinical research trial. This agreement must be reviewed and approved
by the Lead NCTN Program Director in consultation with the Associate Director of CTEP and the Chief, CTEP
Regulatory Affairs Branch, and all appropriate U.S. State Department approvals must be in place for
countries that will be participating in the research as well as other appropriate approvals (e.g., company
partner approvals for trials being conducted under an NCI/DCTD binding collaborative agreement or
CRADA).
With respect to participation of U.S. Network Groups in trials led by a non-U.S. organization (other than the
Canadian Collaborating Clinical Trials Network of the NCTN), there are also numerous logistical, regulatory,
and company-sponsor issues that must be addressed in addition to approval of the non-U.S. trial by the NCI
via the appropriate NCI Scientific Steering Committee (if applicable) and NCI/DCTD/CTEP. Again, it is critical
for any proposal for participation of a U.S. Network Group in a non-U.S. trial to be discussed in advance
with CTEP staff to determine whether participation in such a study is feasible. These trials are required to
have a U.S. Network Group Operations Center identified as the primary or lead sponsor for the trial for the
NCTN Program. A binding collaborative agreement is also required with the international clinical trial
organization that addresses the major components of clinical trial conduct by the international organization
to ensure that the conduct is consistent with all appropriate federal and other appropriate regulations for a
clinical research trial sponsored by the NCTN Program. This will usually also require a trial specific Steering
Committee be in place to address oversight of the trial conduct with respect to regulatory compliance for
the U.S. Network Group Operations Centers participating in the trial as well as to address issues related to
data ownership and biospecimen collection.
In addition, the lead U.S. Network Group Operations Center that is the primary or lead sponsor for the trial
in the U.S. must have U.S. State Department approvals in place for countries that will be participating in the
research even though federal funds will only be used to support the participants from the NCTN Program
enrolling patients on study. The research agreement between the U.S. Network Group Operations Center
that is the primary or lead sponsor for the trial in the U.S. and the international organization leading the
trial that governs the conduct of the study must be reviewed and approved by the Lead NCTN Program
Director in consultation with the Associate Director of CTEP and the Chief, CTEP Regulatory Affairs Branch.
A guidance document from NCI/DCTD/CTEP entitled, Cooperative Group Guidelines for the Development,
Conduct and Analysis of Clinical Trials with International Collaborating Institutions, is available on the CTEP
website at: http://ctep.cancer.gov/investigatorResources/default.htm#guidelines_policies. This document
addresses the various regulatory issues involved in the conduct of international trials that involve
participation/leadership of Network Groups under the NCTN Program.
4. Collective Management of the Network
In order to provide for collaboration and coordination of policies and procedures for the NCTN, collective
management of the Network is needed. To achieve this goal, a core collective management team (i.e., the
NCTN Leadership Management Committee) composed of senior leadership from each of the following key
components of the NCTN Program (i.e., 1 representative from each of the Network Group Operations
Centers, 1 representative from each of the Network Group Statistics and Data Management Centers, 2
representatives from the Canadian Collaborating Clinical Trials Network Organization representing
Operations and Statistics/Data Management, and 1 representative from the Radiotherapy Core Service
Center and 1 representative from the Imaging Core Service Center) and key NCI/DCTD staff (Director
Division DCTD, Associate Director CTEP, Chief and Associate Chiefs of the Clinical Investigations Branch
CTEP, Cancer Diagnosis Branch Associate Director, Tumor Banks Program Director) and the project
scientists/program directors involved in the NCTN Program and key NCI/DCP staff (Deputy Director DCP,
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