NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section III.B.1 – General Review Criteria Information
B. Review Criteria
1. General Information on Review Criteria and Evaluation for All Key Components of the NCTN
The five core review criteria for an application for any of the key components of the NCTN
Program are Significance, Investigators, Innovation, Approach, and Environment (see NIH Guide
Notice NOT-OD-09-025 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-024.html).
The sections below give more detail about how these review criteria are applied for each key
component of the NCTN Program. In addition, some of the key components of the NCTN
Program may have additional specific review criteria that may or may not be scored separately.
The goals of NIH supported research are to advance our understanding of biological systems, to
improve the control of disease, and to enhance health. For the NCTN Program, as previously
stated, the specific goal is to promote excellence in the conduct of clinical treatment and
advanced imaging studies that may lead to a reduction in the incidence of morbidity and
mortality attributable to cancer and the focus of the review is on the ability of each key
component of the NCTN Program to help develop, implement, and conduct meritorious clinical
trials. In their written critiques, reviewers will be asked to comment on each of the criteria in
order to judge the likelihood that the proposed research will have a substantial impact on the
pursuit of these goals. Each of the review criteria will be addressed and considered in assigning
the overall impact/priority score, and weighted as appropriate for each application. Note that an
application does not need to be strong in all categories to be judged likely to have major
scientific impact and thus deserve a high impact/priority score. For example, an investigator may
propose to carry out important work that by its nature is not innovative, but is essential to move
a field forward.
The emphasis of the review criteria for all the 6 key components of the NCTN Program is on the
capabilities and experience of the applicant team to successfully address the specific roles of the
key component in the development, organization, coordination, conduct, and/or support for
future NCTN trials, especially large scale definitive clinical trials. As all applications submitted in
response to the initial Funding Opportunity Announcements (FOAs) for the NCTN program will be
“new” applications, those aspects will be largely evaluated based on the prior performance and
productivity of the applicants. These capabilities and commensurate performance/productivity
must be appropriate and consistent with specific requirements stated in the FOAs with reference
to these Guidelines.
The required capabilities and experience are expected to reflect the properly documented
successful performance of the applicant team under the former NCI National Clinical Trials
Cooperative Group Program or equivalent large-scale NIH or other non-profit clinical trials
networks or programs for the specific key component. Reviewers will be using this information
as benchmarks in evaluating all aspects of an application. In order to provide information on
prior performance and productivity, applicants should provide information related to
performance/productivity in the 5 1/2 calendar years prior to the application receipt date (i.e.,
January 2007 through June 2012).
The complete review criteria for each of the 6 key components of the NCTN Program are
presented in the next sections.
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