NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 1: Overview of NCTN Program Section IV – Terms/Conditions of Award – Network Group Ops Centers
1.1.5 Publications
The Network Group Operations Center is responsible for ensuring timely preparation and
submission of all Network Group publications for peer review. Network Groups must adhere
strictly to the publication policy described in these Terms and Conditions of Award.
Acknowledgement of NCI Support and Scope of Publication Policy: Publication or oral
presentation of work done via the Network Group’s Cooperative Agreements requires
appropriate acknowledgment of NCI support. The definition of publications for this Cooperative
Agreement includes Network Group abstracts, press releases, print-media articles/manuscripts,
electronic media articles/presentations, letters, etc., related to findings and results from NCIsponsored
studies. All Network Group publications must reference the NCI protocol title in the
manuscript or abstract title whenever relevant to the publication.
Publication Timelines: Timely publication of major Network Group findings is central to the
mission of the Group and is a primary means by which the Network Group’s accomplishments
can be evaluated. Timely presentation of a study’s findings and results is especially important
when a DMSB recommends the public release of this information.
It is expected that preliminary results of major phase 3 trials will be presented at a scientific
meeting within 6 to 8 months of completion of the study analysis (if not sooner based on the
relevance of the results). It is a requirement under the Terms of Awards that a full manuscript
on the study results be prepared and submitted for publication in the peer-reviewed literature
(not as an abstract) within 1 year of the availability of the primary study results based on the
completion date of the study recorded in the U.S. National Library of Medicine database,
clinicaltrials.gov. Exceptions to this policy must be approved in writing by the Lead NCTN
Program Director (e.g., an exception may be made for results that are being analyzed for a
marketing/licensing application to the FDA by a company partner). Also, these timelines may be
modified in the future by NCI institute-wide requirements that are in development.
It is also a requirement of these Terms of Award that the results of all NCTN studies be
submitted as required by the Food and Drug Administration Amendments Act (FDAAA) Section
801 to comply with the rules defined for inclusion of clinical trial information in clinicaltrials.gov.
The Network Group Operations Center should have mechanisms for monitoring the performance
of the Center, its associated Statistics and Data Management Center, and scientific committees
in meeting these time-lines and should have corrective action plans in place for when these
time-lines are not met.
Pre-Publication Review:
� For any study using agent(s) supplied under CTEP Collaborative Agreements (e.g., CRADA,
CTA, or CSA), both CTEP and the NCI pharmaceutical/biotechnology collaborator(s) will have
a 30-day period in which to review any manuscripts for informational purposes as well as for
comment (as per the NCI Standard Protocol Language for CTEP Collaborative Agreements)
prior to submission of the manuscript by the Group for publication. An additional 30 days
may be requested in order to ensure that confidential and proprietary data, in addition to
the intellectual property rights of the Collaborator(s), are protected. In addition, the NCI
pharmaceutical/biotechnology collaborator(s) will have courtesy review of any abstracts as
soon as possible (preferably at least 3 days prior to submission), but in any case, prior to
presentation or publication. Manuscripts and abstracts should be provided to CTEP for
delivery to the NCI pharmaceutical/biotechnology collaborator(s). Pre-review timing for
publications other than abstracts or manuscripts for studies involving agents supplied under
CTEP Collaborative Agreements should be discussed with appropriate CTEP staff in the
Investigational Drug Branch and the Regulatory Affairs Branch.
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