NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section III.B.2.1 – Review Criteria
Network Group Operations Center
Approach
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to
accomplish the specific aims of the proposed Network Group Operations Center? Are
potential problems, alternative strategies, and benchmarks for success presented? If the
project is in the early stages of development, will the strategy establish feasibility and
will particularly risky aspects be managed?
Are the plans for 1) protection of human subjects from research risks, and 2) inclusion of
minorities and members of both sexes/genders, as well as the inclusion of children,
justified in terms of the scientific goals and research strategy proposed?
Environment
Will the scientific environment in which the work will be done contribute to the
probability of success? Are the institutional support, equipment and other physical
resources available to the investigators adequate for the project proposed? Will the
clinical research conducted by the Network Group Operations Center benefit from
unique features of the scientific environment, subject populations, or collaborative
arrangements?
Additional Scored Review Criteria
In addition to the above review criteria, the following criteria will be applied to
applications in the determination of scientific merit and the impact/priority score.
Reviewers will consider each of the additional review criteria below in the
determination of scientific merit, and give a separate score for each.
A. Clinical Trials Development Program
B. Member Site Accrual Program
C. Operational Management
D. Program for Collaborations & Participation in Collective Management of NCTN
2.1.3 Scored Review Criteria – Criterion A. Clinical Trial Development Program
(Note: The entire Criterion A will receive one individual score; the subcategories and
aspects listed will be assessed but not scored separately).
Significance
Overall Research Strategy: How well does the applicant's research strategy reflect an
integrated scientific approach within oncology disease areas as well as across disease
areas? Does the research strategy address important unmet clinical needs? Is the
research strategy sufficiently practical and feasible? Are the disease areas included in
the applicant’s overall research strategy appropriate and beneficial to the NCTN? How
well would the applicant team contribute to the development of clinical trials for
patients with rare cancers and how well would the applicant address underserved
patient populations through trials that it leads or participates in across the NCTN?
Quality of Clinical Trials: Based on the clinical trials currently being conducted as well as
those proposed, what is the likelihood that the applicant's team can contribute
meaningfully to developing and implementing multi-disciplinary, multi-institutional trials
in a broad range of cancer types and special populations with specific scientific strategy
and goals? Do the trials contain important integral and integrated translational science
research questions that are appropriate and well justified? To what degree do their
results reflect qualitatively new knowledge that advances the field and may inspire
future clinical trials? Will (or have) the results lead (led) to meaningful practice changes
for cancer care or other meaningful results (e.g., Phase 2 trials leading to Phase 3 trials
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