NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 1: Overview of NCTN Program Section III – General Management & Network Operating/Funding Principles
C. Network Operating Principles
As described in the background section of these Guidelines, the purpose of the new NCTN Program is to provide
standing support for a consolidated and integrated national Network that conducts treatment trials and
advanced imaging trials in oncology for both adult and pediatric patients on an ongoing basis. In this Network,
Groups will collaborate with each other and with NCI to achieve the research objectives of the Network based
on operating principles that stress harmonization of procedures used by the individual Network Groups and
their member institutions/sites, required use of standard tools and services for clinical trial conduct (e.g.,
centralized patient enrollment and regulatory support, common data management system, core services
support for radiotherapy and imaging in clinical trials) to ensure that NCTN trials are developed and conducted
as efficiently as possible and with collaboration and coordination among the Network Groups and other NCIsupported
program and investigators.
1. Access to NCTN Trials & Crediting for Patients Accrual to Trials
Network Groups member institutions/sites will be able to enroll patients on all adult phase 3 trials (and
selected phase 2 trials) conducted by the Network, irrespective of the specific Network Group which is
leading the trial and providing data management and statistical analysis for it. Lead Academic Participating
Sites (as well as any affiliates included in their award) and CCOPs/MB-CCOPs will be able to credit any
Network Group to which they belong for any treatment or advanced imaging trial for adult cancer patients.
Other member institutions/sites of the adult Network Groups are also allowed to credit any Network Group
of which they are a member for patient accrual except that non-Canadian international sites must credit the
Network Group that is leading the NCTN trial if they are a member of that Group to ensure consistency of
regulatory oversight outside North America. Canadian sites that belong to more than 1 Network Group may
also need to credit the Network Group that holds a Clinical Trial Application (CTA) for the trial in Canada per
the Health Canada regulations.
It is also anticipated that affiliates of main members for a particular Network Group will follow the crediting
decision of the main member for a particular trial; however, that is at the discretion of the Network Groups
through their membership rules. Institutions/sites that are members of the pediatric Network Group must
credit the pediatric Network Group when it is leading a trial.
Earlier adult phase trials will also be open Network-wide, depending on the accrual needs of the trial and its
suitability for broad enrollment. In addition, it is anticipated that selected trials for adolescent and young
adults will be open Network-wide.
Note: International sites (i.e., non-U.S. sites) that are full members of any of the Network Group
Operations Center or the Canadian Collaborating Clinical Trials Network may not be able to participate in all
NCTN trials because of special regulatory issues specific to the country of the international member. The
Network Group Operations Centers must specify any potential restrictions related to enrollment from
international members prior to trial activation. For trials being conducted under an NCI/DCTD IND, this
information must be reviewed and approved by NCI prior to trial activation.
2. Submission of Data and Biospecimens for NCTN Trials
All data, as well as any biospecimens collected, for an NCTN trial must be sent by the institutions/sites
participating in the trial to the Network Group that is leading the trial, unless an exception is approved by
the NCI to accommodate the needs of a specific trial.
3. Use of the NCI Central Institutional Review Board
All U.S. institutions/sites participating in NCTN trials as members of 1 or more Network Groups (including
Network Lead Academic Participating Sites, CCOPs, and MB-CCOPs) are required to use the pediatric and/or
adult NCI Central Institutional Review Board for any NCTN trial under an NCI CIRB’s purview. See
http://www.ncicirb.org for information on the requirements for a signatory institution under the NCI CIRBs.
This requirement may be waived by the Lead NCTN Program Director through an exemption review process
if the institution/site can adequately show that NCTN studies can be reviewed in a timely manner by its
local IRB (or other Central IRB) that is equivalent to the review timelines for the NCI CIRB (i.e., about 35 to
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