NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section III.B.2.4 – Review Criteria
Network Lead Academic Participating Site
Approach
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to
accomplish the specific aims of the proposed Network Lead Academic Participating
Site? 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?
Since the proposed Network Lead Academic Participating Site will help conduct
clinical research, 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, if applicable, 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 analyzed and the clinical data managed by the Network Lead
Academic Participating Site 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 Trial Program
B. Site Accrual Program
2.4.3 Scored Review Criteria – Criterion A. Clinical Trial Program
(Note: The entire Criterion A will receive one individual score; the subcategories and
aspects listed will be assessed but not scored separately).
How complete and comprehensive are the expertise of the PD(s)/PI(s) and the entire
team of investigators assembled by the applicants in terms of their ability to provide
scientific leadership for state-of-the-art early and late phase clinical trials in adults
with cancer? Will these investigators be able to work as a cohesive research team at
the institution and with their associated adult Network Groups to efficiently and
expeditiously complete NCTN clinical trials? Are the proposed governance structure,
decision-making processes, and interactions among the leadership at the site optimal
for participating in multi-disciplinary, multi-institutional trials in a range of cancer
types and special populations with diverse scientific strategies?
Do the research experience and qualifications of the Program Director(s)/Principal
Investigator(s) provide multi-disciplinary representation in several relevant fields (e.g.,
in medical oncology, radiation oncology, imaging, surgery) and across a broad range
of cancers? Have the PD(s)/PI(s) and other investigators involved in NCTN research at
the site have a track record of successful multi-institutional early phase and,
especially, late phase clinical trials research as evidenced by publications?
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