NCI National Clinical Trials Network (NCTN) Program Guidelines

PART 2: Submission of New/Competing Application Section III.B.2.6 – Review Criteria
Canadian Collaborating Clinical Trials Network
Approach
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to
accomplish the specific aims of the proposed Canadian Collaborating Clinical Trials
Network? 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 Canadian Collaborating Clinical Trials Network will 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 conducted by the proposed Canadian Collaborating Clinical Trials
Network benefit from unique features of the scientific environment, subject
populations, or collaborative arrangements?
Additional Review Criteria - Overall
As applicable for the research that the Canadian Collaborating Clinical Trials Network
applicant has proposed, reviewers will evaluate the following additional items A-C
listed below while determining scientific and technical merit, and in providing an
overall impact/priority score, but will not give separate scores for these items.
2.6.3 Additional Review Item A - Clinical Trial Development & Member Site Accrual Program
Overall Research Strategy: Does the applicant articulate a clear, well-developed,
overall research strategy to achieve the stated clinical research goals with respect to
complementing the research of the U.S. Network Groups of the NCTN Program? Is
the research strategy for complementing research activities of the NCTN Program
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 contribute to the development of and/or accrual to clinical trials in rare
cancers?
Clinical Trial Quality: Do the clinical trials currently being conducted as well as those
proposed by the applicant address important clinical treatment questions based on
strong hypotheses and preliminary data and indicate that the applicant can contribute
meaningfully in the NCTN? Do the trials use scientifically rigorous approaches to trial
design with use of innovative approaches as appropriate and with sound justification?
Do the trials contain integral and integrated translational science research questions
that are appropriate and well-justified to answer specific research questions? Is the
past record of results from the trials completed by the applicant scientifically
important? Do these results provide new information that advances the field and
provide guidance for future trials? Will (or have) the results lead (led) to meaningful
practice changes for cancer care, supported FDA approvals of oncologic drugs or
devices, changes in practice guidelines, or other meaningful impacts (e.g., phase 2
trials leading to phase 3 trials conducted by government or private sector, provision of
important toxicity or dosing information)? Does the applicant's record of past results
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